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30 API Suppliers, 15 USDMF, 10 CEP/COS, 3 EU WC, 3 KDMF, 8 NDC API, 16 Listed Suppliers, $ API Reference Price

30 API Suppliers
15 USDMF
10 CEP/COS
3 EU WC
3 KDMF
8 NDC API
16 Listed Suppliers
$ API Reference Price

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24 Drugs in Development

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4 Intermediates Suppliers

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202 FDF Dossiers, 58 FDA Orange Book, 70 Europe, 12 Canada, 18 Australia, 13 South Africa, 31 Listed Dossiers

202 FDF Dossiers
58 FDA Orange Book
70 Europe
12 Canada
18 Australia
13 South Africa
31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG, CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 30MG, CAPSULE;ORAL - 35MG, CAPSULE;ORAL - 40MG

drugProductComposition
CAPSULE;ORAL - 10MG
CAPSULE;ORAL - 20MG
CAPSULE;ORAL - 25MG
CAPSULE;ORAL - 30MG
CAPSULE;ORAL - 35MG
CAPSULE;ORAL - 40MG

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69 Finished Drug Prices

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4 FDF Dossiers

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12 US Patents

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12 US Patents

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Synopsis

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CEP/COS

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Listed Suppliers

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202

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

24DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

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US Patents

US Exclusivities

Health Canada Patents

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Data Compilation #PharmaFlow

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US Medicaid (USD)

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Annual Reports (USD Million)

Finished Drug Prices

98 RELATED EXCIPIENT COMPANIES

176EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 4759-48-2, 13-cis-retinoic acid, Accutane, Roaccutane, Claravis, Neovitamin a acid

Molecular Formula

C₂₀H₂₈O₂

Molecular Weight

300.4 g/mol

InChI Key

SHGAZHPCJJPHSC-XFYACQKRSA-N

FDA UNII

EH28UP18IF

A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.

Isotretinoin is a Retinoid.

1 2D Structure

Isotretinoin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid

2.1.2 InChI

InChI=1S/C20H28O2/c1-15(8-6-9-16(2)14-19(21)22)11-12-18-17(3)10-7-13-20(18,4)5/h6,8-9,11-12,14H,7,10,13H2,1-5H3,(H,21,22)/b9-6+,12-11+,15-8+,16-14-

2.1.3 InChI Key

SHGAZHPCJJPHSC-XFYACQKRSA-N

2.1.4 Canonical SMILES

CC1=C(C(CCC1)(C)C)C=CC(=CC=CC(=CC(=O)O)C)C

2.1.5 Isomeric SMILES

CC1=C(C(CCC1)(C)C)/C=C/C(=C/C=C/C(=C\C(=O)O)/C)/C

2.2 Other Identifiers

2.2.1 UNII

EH28UP18IF

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 13 Cis Retinoic Acid

2. 13-cis-retinoic Acid

3. Accutane

4. Isotretinoin Zinc Salt, 13 Cis Isomer

5. Isotretinoin Zinc Salt, 13-cis-isomer

6. Ro 4 3780

7. Ro 4-3780

8. Ro 43780

9. Roaccutane

2.3.2 Depositor-Supplied Synonyms

1. 4759-48-2

2. 13-cis-retinoic Acid

3. Accutane

4. Roaccutane

5. Claravis

6. Neovitamin A Acid

7. 13-cis-vitamin A Acid

8. Amnesteem

9. Isotrex

10. Sotret

11. 13-cis Retinoic Acid

12. Teriosal

13. Isotretinon

14. Isotretinoino

15. Isotretinoine

16. Isotretinoinum

17. Absorica

18. Roaccutan

19. 13-ra

20. Retinoic Acid, 13-cis-

21. Roacutan

22. Isotretinoine [inn-french]

23. Isotretinoinum [inn-latin]

24. Isotretinoino [inn-spanish]

25. Cip-isotretinoin

26. Ro-4-3780

27. Accutane (tn)

28. Isotretinoin (usp)

29. Ro 4-3780

30. Cis-ra

31. (7e,9e,11e,13z)-retinoic Acid

32. Ro-43780

33. (13cis)-retinoic Acid

34. 13-cis Ra

35. Vitamin A Acid, 13-cis

36. Chembl547

37. Nsc-758156

38. Eh28up18if

39. Chebi:6067

40. 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)2-cis-4-trans-6-trans-8-trans-nonatetraenoic Acid

41. Retinoic Acid, (9,13-cis)-

42. Pat-001

43. 13-cis-retinoic Acid,isotretinoin

44. (2z,4e,6e,8e)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic Acid

45. Isotane

46. (2z,4e6e,8e)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic Acid

47. Cis-retinoic Acid

48. Myorisan

49. Zenatane

50. Isosuprea Lidose

51. 286464-92-4

52. Sotret (tn)

53. Ccris 4286

54. Hsdb 3929

55. 13 Cis-retinoic Acid

56. Sr-01000076103

57. Einecs 225-296-0

58. Unii-eh28up18if

59. Brn 1885770

60. Isotretinoina

61. Cis-retinoate

62. Bml2-e07

63. Isotretinoin [usan:ban:inn]

64. Cis Retinoic Acid

65. Trans-retinoicacid

66. Absorica (tn)

67. Prestwick_642

68. Cas-4759-48-2

69. Isotretinoin [usan:usp:inn:ban]

70. (2z,4e,6e,8e)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic Acid

71. Absorica Ld

72. (13-cis)-retinoate

73. Cpd000471891

74. 13cra

75. Prestwick2_000256

76. Prestwick3_000256

77. Spectrum5_001795

78. Spectrum5_001937

79. Isotretinoin [mi]

80. (13-cis)-retinoic Acid

81. Dsstox_cid_3177

82. Isotretinoin [inn]

83. Isotretinoin [hsdb]

84. Isotretinoin [usan]

85. R 3255

86. Retinoic Acid 13-cis-form

87. Retinoic Acid, (13cis)-

88. Dsstox_rid_76906

89. Isotretinoin [vandf]

90. Dsstox_gsid_23177

91. Lopac0_001081

92. Schembl38299

93. Bspbio_000072

94. Bspbio_001331

95. Bspbio_003345

96. Isotretinoin [mart.]

97. 4-09-00-02388 (beilstein Handbook Reference)

98. Mls001074662

99. Isotretinoin [usp-rs]

100. Isotretinoin [who-dd]

101. Spectrum1502013

102. Bpbio1_000080

103. Gtpl7600

104. Dtxsid4023177

105. Hms1361c13

106. Hms1568d14

107. Hms1791c13

108. Hms1921d08

109. Hms1989c13

110. Hms2092n07

111. Hms2095d14

112. Hms2233a07

113. Hms3259j09

114. Hms3263i04

115. Hms3402c13

116. Hms3712d14

117. Hms3884a13

118. Isotretinoin [orange Book]

119. Pharmakon1600-01502013

120. Isotretinoin [ep Monograph]

121. Bcp18950

122. Zinc3792789

123. Isotretinoin [usp Monograph]

124. Tox21_200093

125. Tox21_501081

126. Bdbm50031459

127. Lmpr01090021

128. Mfcd00079542

129. Nsc758156

130. Akos015841158

131. Ccg-205158

132. Cs-1864

133. Db00982

134. Ds-3367

135. Lp01081

136. Nc00635

137. Nsc 758156

138. Sdccgsbi-0051051.p004

139. Idi1_033801

140. Ncgc00094358-01

141. Ncgc00094358-02

142. Ncgc00094358-03

143. Ncgc00094358-04

144. Ncgc00094358-05

145. Ncgc00094358-06

146. Ncgc00094358-07

147. Ncgc00094358-08

148. Ncgc00094358-09

149. Ncgc00094358-10

150. Ncgc00094358-11

151. Ncgc00094358-12

152. Ncgc00094358-13

153. Ncgc00094358-14

154. Ncgc00094358-15

155. Ncgc00094358-26

156. Ncgc00257647-01

157. Ncgc00261766-01

158. Retinoic Acid 13-cis-form [mi]

159. Br164589

160. Hy-15127

161. Smr000471891

162. 13-cis-retinoic Acid, >=98% (hplc)

163. Sbi-0051051.p003

164. Tretinoin Impurity A [ep Impurity]

165. Eu-0101081

166. R0088

167. 59i482

168. C07058

169. D00348

170. A917531

171. Q287029

172. Sr-01000076103-2

173. Sr-01000076103-5

174. Sr-01000076103-6

175. Sr-01000076103-9

176. Brd-k76723084-001-05-9

177. Sr-01000076103-10

178. Isotretinoin, European Pharmacopoeia (ep) Reference Standard

179. Isotretinoin, United States Pharmacopeia (usp) Reference Standard

180. (2z,4e)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)-2,4,6,8-nonatetraenoic Acid

181. Isotretinoin For Peak Identification, European Pharmacopoeia (ep) Reference Standard

182. Isotretinoin, Pharmaceutical Secondary Standard; Certified Reference Material

183. (2z,4e,6e,8e)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic Acid

184. (2z,4e,6e,8e)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenoic Acid

185. (2z,4e,6e,8e)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoicacid

186. 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-cis-4-trans-6-trans-8-trans-nonatetraenoic Acid

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₈O₂
Molecular Weight	300.4 g/mol
XLogP3	6.3
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	5
Exact Mass	300.208930132 g/mol
Monoisotopic Mass	300.208930132 g/mol
Topological Polar Surface Area	37.3 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	567
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	4
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Absorica
PubMed Health	Isotretinoin (By mouth)
Drug Classes	Antiacne, Dermatological Agent
Drug Label	ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ranbaxy

2 of 8
Drug Name	Amnesteem
PubMed Health	Isotretinoin (By mouth)
Drug Classes	Antiacne, Dermatological Agent
Drug Label	Isotretinoin, USP a retinoid, is available as Amnesteem (isotretinoin capsules, USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated v...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	10mg; 40mg; 20mg
Market Status	Prescription
Company	Mylan Pharms

3 of 8
Drug Name	Claravis
Drug Label	Isotretinoin, USP, a retinoid, is available as Claravis (isotretinoin capsules USP) in 10 mg, 20 mg, 30 mg and 40 mg hard gelatin capsules for oral administration. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic ac...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Teva Pharms Usa

4 of 8
Drug Name	Sotret
PubMed Health	Isotretinoin (By mouth)
Drug Classes	Antiacne, Dermatological Agent
Drug Label	Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ranbaxy

5 of 8
Drug Name	Absorica
PubMed Health	Isotretinoin (By mouth)
Drug Classes	Antiacne, Dermatological Agent
Drug Label	ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ranbaxy

6 of 8
Drug Name	Amnesteem
PubMed Health	Isotretinoin (By mouth)
Drug Classes	Antiacne, Dermatological Agent
Drug Label	Isotretinoin, USP a retinoid, is available as Amnesteem (isotretinoin capsules, USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated v...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	10mg; 40mg; 20mg
Market Status	Prescription
Company	Mylan Pharms

7 of 8
Drug Name	Claravis
Drug Label	Isotretinoin, USP, a retinoid, is available as Claravis (isotretinoin capsules USP) in 10 mg, 20 mg, 30 mg and 40 mg hard gelatin capsules for oral administration. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic ac...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Teva Pharms Usa

8 of 8
Drug Name	Sotret
PubMed Health	Isotretinoin (By mouth)
Drug Classes	Antiacne, Dermatological Agent
Drug Label	Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil...
Active Ingredient	Isotretinoin
Dosage Form	Capsule
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ranbaxy

4.2 Therapeutic Uses

Dermatologic Agents; Teratogens

National Library of Medicine's Medical Subject Headings. Isotretinoin. Online file (MeSH, 2018). Available from, as of August 29, 2018: https://meshb.nlm.nih.gov/search

/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Isotretinoin is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of August 29, 2018: https://clinicaltrials.gov/

Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. /Included in US product labeling/

NIH; DailyMed. Current Medication Information for Isotretinoin Capsule, Liquid Filled (Updated: June 30, 2017). Available from, as of September 13, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c2917c3d-3499-48a0-ba53-120cb979195d

Isotretinoin has been used in the treatment of cutaneous disorders of keratinization that are resistant to treatment with other agents (e.g., corticosteroids, topical tretinoin); however, the specific role of isotretinoin in the treatment of these disorders and the safety of long-term use and high dosages of the drug have not been determined. /NOT included in US product labeling/

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

Isotretinoin has been used in a limited number of patients in the prevention, treatment, and adjunctive treatment of various cutaneous and extracutaneous malignant neoplasms (of epithelial origin); however, the specific role of the drug in the treatment of these conditions has not been determined and additional study is needed. /NOT included in US product labeling/

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

4.3 Drug Warning

/BOXED WARNING/ Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a female patient who is taking isotretinoin, isotretinoin must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements Because of isotretinoin's teratogenicity and to minimize fetal exposure, isotretinoin is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE. Isotretinoin must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Isotretinoin must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE.

Pregnancy risk category: X /CONTRAINDICATED IN PREGNANCY. Studies in animals or humans, or investigational or post-marketing reports, have demonstrated positive evidence of fetal abnormalities or risk which clearly outweights any possible benefit to the patient./

Isotretinoin is teratogenic in humans and is contraindicated during pregnancy. Unless abstinence is the chosen method, it is recommended that the patient use two forms of effective contraception to prevent pregnancy, starting 1 month before initiation of treatment, during treatment, and for 1 month after discontinuation of treatment.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1696

Although not every fetus exposed to isotretinoin has been affected, the risk is high that an infant will have a deformity or abnormality if the pregnancy occurred while the mother was taking isotretinoin, even for a short period of time. Whenever an unexpected pregnancy occurs during the time of teratogenic risk, the risk-benefit ratio of continuing the pregnancy must be considered. The risks include: 15% incidence of major malformations, 5% incidence of perinatal mortality, 16% incidence of premature birth, and 40% incidence of spontaneous abortion.

For more Drug Warnings (Complete) data for 13-cis-Retinoic acid (40 total), please visit the HSDB record page.

4.4 Drug Indication

Isotretinoin is indicated to treat severe recalcitrant nodular acne and patients 12 years enrolled in the iPLEDGE program.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

The pharmacodynamics of isotretinoin are poorly understood.

5.2 MeSH Pharmacological Classification

Dermatologic Agents

Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)

Teratogens

An agent that causes the production of physical defects in the developing embryo. (See all compounds classified as Teratogens.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

ISOTRETINOIN

5.3.2 FDA UNII

EH28UP18IF

5.3.3 Pharmacological Classes

Retinoids [CS]; Retinoid [EPC]

5.4 ATC Code

D - Dermatologicals

D10 - Anti-acne preparations

D10A - Anti-acne preparations for topical use

D10AD - Retinoids for topical use in acne

D10AD04 - Isotretinoin

D - Dermatologicals

D10 - Anti-acne preparations

D10B - Anti-acne preparations for systemic use

D10BA - Retinoids for treatment of acne

D10BA01 - Isotretinoin

5.5 Absorption, Distribution and Excretion

Absorption

Patients reach a maximum concentration of 74-511ng/mL after 1-4 hours following a 100mg oral dose. Isotretinoin is better absorbed with a high fat meal and bioavailability may change from one brand to another. Following a 40mg oral dose, fasted subjects reached a maximum concentration of 314ng/mL in 2.9 hours with an area under the curve of 4055ng/mL\*hr. Subjects given a high fat meal and a 40mg oral doses reached a maximum concentration of 395ng/mL in 6.4 hours with an area under the curve of 6095ng/mL\*mL.

Route of Elimination

Isotretinoin and its metabolites are conjugated and excreted in the urine and feces in similar amounts. 53-74% of an oral dose is eliminated as unchanged isotretinoin in the feces.

Volume of Distribution

The volume of distribution in humans is unknown because there is no intravenous preparation. In a study of pediatric patients with neuroblastoma the volume of distribution was found to be 85L. The volume of distribution was also found to be 2432mL/kg in guinea pigs and 1716mL/kg in obese rats.

Clearance

The clearance of isotretinoin is 15.9L/h in pediatric patients with neuroblastoma. Clearance is also 21.3mL/min/kg in guinea pigs and 7.2mL/min/kg in obese rats.

Following oral administration of isotretinoin, there is an apparent lag time of about 0.5-2 hours before the drug appears in systemic circulation. The lag time is thought to result from disintegration of the capsule and subsequent dissolution of the drug in GI contents. Absorption of the drug after this lag time is rapid. The actual bioavailability of orally administered isotretinoin has not been determined in humans, but studies in animals indicate that about 25% of an oral dose of the drug reaches systemic circulation as unchanged isotretinoin The low bioavailability observed in animals may result from biodegradation of the drug in the GI lumen and/or metabolism of the drug during absorption (in the GI mucosa) and first pass through the liver. Food and/or milk increase GI absorption of isotretinoin. Peak blood isotretinoin concentrations are slightly delayed and substantially increased and the area under the blood concentration-time curve (AUC) of the drug is approximately 1.5-2 times greater when isotretinoin is administered 1 hour before, concomitantly with, or 1 hour after a meal than when the drug is administered in the fasting state. Because of its high lipophilicity, oral absorption of isotretinoin is enhanced when the drug is administered with a high-fat meal. In a crossover study of 74 healthy adults who received a single 80-mg isotretinoin dose (as two 40-mg capsules) under fasted and fed conditions, both the peak plasma concentration and total area under the plasma concentration-time curve (AUC) of the drug were more than doubled when isotretinoin was administered immediately after a standardized high-fat meal compared with administration in the fasted state. Because the observed elimination half-life of the drug remained unchanged, it is suggested that food appears to increase the bioavailability of isotretinoin without altering its disposition. The time to peak concentration was also increased with food and may be related to a longer absorption phase. Consequently, the manufacturers recommend that isotretinoin capsules always be administered with food.

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

The harmonic mean elimination for the simultaneous iv and oral administration of isotretinoin was approx 5.5 hr. The mean blood clearance, following iv admin, and the intrinsic clearance, following oral administration, were 5.19 and 6.63 mL/min/kg, respectively. The average abs bioavailability was approx 21% indicating an overall 1st-pass effect of approx 80%. Analysis of gut contents for total (14)-C activity suggested that a fraction of the isotretinoin dose was biologically or chemically degraded in the gut lumen prior to absorption.

PMID:6138231 Cotler S et al; DRUG METAB DISPOS 11 (5): 458-62 (1983)

Clinical doses of isotretinoin range from 0.5 to 8 mg/kg/day, with acute side effects appearing following doses of 1 mg/kg/day or greater. Plasma concn of isotretinoin following single and multiple doses peak between 2 to 4 hr and exhibit elimination half-lives of 10 to 20 hr. Isotretinoin blood concn-time curves following a single- or multiple-dose regimen are well described by a linear model with biphasic disposition characteristics. ... In most conditions, the retinoids produce a maximal effect in about 8 weeks (at the highest tolerated dose), with a slow recurrence of symptoms usually occurring within several weeks following cessation of treatment - except in the treatment of cystic acne with isotretinoin. Maintenance or intermittent dosing usually results in a prolongation of remission.

PMID:3882304 Lucek RW, Colburn WA; Clin Pharmacokinet 10 (1): 38-62 (1985)

A case study involving the disposition of 13-cis retinoic acid in embryonic tissues from a woman who unintentionally took 40 mg/day of isotretinoin from day 8-28 of gestation was discussed. When the pregnancy was terminated on day 31, between 72 and 80 hr after the last dose of isotretinoin, maternal serum samples were obtained. Retinoid concn in the maternal serum, embryonic tissue, and 6 samples of placental tissue were later measured by high performance liquid chromatography. The results showed that in humans, the intake of isotretinoin during pregnancy results in high placental and embryonic concn of all-trans-retoinic acid, in contrast to what was previously discovered in mice experiments. It was concluded that the metabolic activation of isotretinoin to the all-trans isomer could be responsible for the teratogenicity of isotretinoin.

Kraft JC et al; N Engl J Med 321 (Jul 27): 262 (1989)

For more Absorption, Distribution and Excretion (Complete) data for 13-cis-Retinoic acid (11 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Isotretinoin, or 13-cis-retinoic acid can undergo reversible cis-trans isomerization to all-trans-retinoic acid. Isotretinoin undergoes 4-hydroxylation to 4-hydroxy-13-cis-retinoic acid, which is oxidized to the main metabolite 4-oxo-13-cis-retinoic acid.. All-trans-retinoic acid undergoes 4-hydroxylation to 4-hydroxy-all-trans-retinoic acid, which is oxidized to 4-oxo-all-trans-retinoic acid. 4-oxo-13-cis-retinoic acid can undergo reversible cis-trans isomerization to 4-oxo-all-trans-retinoic acid.

... In human volunteers and patients, one major blood metabolite of isotretinoin is 4-oxo-isotretinoin which undergoes slower elimination than isotretinoin and may itself be a participant in teratogenesis.

PMID:3478842 Kochhar DM, Penner JD; Teratology 36 (1): 67-75 (1987)

This paper reviews the teratogenicity of isotretinoin in regard to aspects of species variation, toxicokinetics, and metabolism. The insensitive species (rat, mouse) eliminate the drug rapidly through detoxification to the beta-glucuronide; also, placental transfer is limited in these species. On the other hand, in sensitive species (primates), the drug is predominantly metabolized to the active 13-cis-4-oxo-retinoic acid; placental transfer is more extensive here. The beta-glucuronides showed limited placental transfer in all species examined; these metabolites exhibited very low, if any, measurable concentrations in the human. The 13-cis-retinoic acid is not appreciably bound to cellular retinoid-binding proteins or nuclear receptors and exhibits low tissue distribution and placental transfer. Its access to the nucleus may be extensive. Because of the long half life of 13-cis-retinoic acid, continuous isomerization results in significant area under the concentration-time curve levels of all-trans-retinoic acid in the mouse, monkey and the human; the all-trans-retinoic acid formed is extensively distributed across the placenta and may be an important factor that contributes to the teratogenic potency of 13-cis-retinoic acid. Isomerization cannot explain the teratogenic effects of 13-cis-retinoic acid in the rat and rabbit. It is concluded that the high teratogenic activity of isotretinoin in sensitive species (human, monkey) is related to slow elimination of the 13-cis-isomer, to metabolism to the 4-oxo-derivative, to increased placental transfer, to continuous isomerization and significant exposure of the target tissue to all-trans-retinoic acid; and to lack of binding to cytoplasmic retinoid binding proteins that could possibly result in ready access to the nucleus.

Nau H; J Am Acad Dermatol 45 (5): S183-7 (2001)

Isotretinoin is metabolized in the liver by the cytochrome P-450 (CYP) microsomal enzyme system, principally by CYP2C8, CYP2C9, CYP3A4, and CYP2B6 isoenzymes, to several metabolites (e.g., 4-oxo-isotretinoin, retinoic acid [tretinoin], and 4-oxo-retinoic acid [4-oxo-tretinoin]). Retinoic acid and 13-cis-retinoic acid are geometric isomers and show reversible interconversion, and the administration of one isomer will give rise to the other. Isotretinoin also is irreversibly oxidized to 4-oxo-isotretinoin, which forms its own geometric isomer, 4-oxo-tretinon. All of these metabolites possess retinoid activity that is more than that of the parent compound in some in vitro models. However, the clinical importance of these models is unknown. Concurrent administration of food has been shown to increase the extent of formation of all metabolites in plasma when compared to administration of isotretinoin under fasted conditions. In addition, the exposure of patients to 4-oxo-isotretinoin at steady-state under fasted and fed conditions was approximately 3.4 times higher than that of isotretinoin.

In vitro studies indicate that the primary P450 isoforms involved in isotretinoin metabolism are 2C8, 2C9, 3A4 and 2B6. Isotretinoin and its metabolites are further metabolized into conjugates, which are then excreted in urine and feces.

For more Metabolism/Metabolites (Complete) data for 13-cis-Retinoic acid (6 total), please visit the HSDB record page.

Isotretinoin has known human metabolites that include (2Z,4E,6Z,8E)-6-hydroxy-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.7 Biological Half-Life

The half life ranges from 7-39 hours with a mean elimination half life of 20 hours. The half life of 4-oxo-13-cis-retinoic acid ranges from 17-50 hours with a mean elimination half life of 25 hours.

Following oral administration of an 80 mg dose of (14)C-isotretinoin as a liquid suspension, (14)C-activity in blood declined with a half-life of 90 hours.

After a single 80 mg oral dose of isotretinoin to 74 healthy adult subjects under fed conditions, the mean +/- SD elimination half-lives of isotretinoin and 4-oxo-isotretinoin were 21 +/- 8.2 hours and 24 +/- 5.3 hours, respectively.

Blood concentrations of isotretinoin decline in a biphasic manner. In adults with normal renal function, the half-life in the initial phase averages 0.5 hours and the half-life in the terminal phase averages 10-20 hours (range: 7-39 hours).

American Society of Health-System Pharmacists; Drug Information 2018. Bethesda, MD. 2018

... Plasma concentration of isotretinoin following single and multiple doses peak between 2 to 4 hr and exhibit elimination half-lives of 10 to 20 hr ...

PMID:3882304 Lucek RW, Colburn WA; Clin Pharmacokinet 10 (1): 38-62 (1985)

For more Biological Half-Life (Complete) data for 13-cis-Retinoic acid (6 total), please visit the HSDB record page.

5.8 Mechanism of Action

Isotretinoin produces its effects through altering progress through the cell cycle, cell differentiation, survival, and apoptosis. These actions reduce sebum production, preventing the blockage of pores, and growth of acne causing bacteria. Isotretinoin and 4-oxo-isotretinoin both significantly reduce the production of sebum. Isotretinoin has little to no affinity for retinol binding proteins (RBPs) and retinoic acid nuclear receptors (RARs). Tretinoin and 4-oxo-tretinion bind to the RAR- receptor, which is suspected to be part of the action of acne treatment by isotretinoin. Isotretinoin induces apoptosis in sebocytes, leading to a decrease in sebum production. Isotretinoin also reduces the formation of comedones by reducing hyperkeratinization through an unknown mechanism. Isotretinoin does not directly kill bacteria but it does reduce the size of sebum ducts and makes the microenvironment less hospitable to acne causing bacteria. It may also increase immune mechanisms and alter chemotaxis of monocytes to reduce inflammation. There is preliminary evidence suggesting isotretinoin may interact with FoxO1, which may explain a substantial number of isotretinoin's unexplained actions.

Nau H; J Am Acad Dermatol 45 (5): S183-7 (2001)

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Rev. Date : 2014-05-13

Pay. Date : 2013-09-25

DMF Number : 27484

Submission : 2013-09-27

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Type : II

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"109.00","actualQuantity":"109","unit":"KGS","unitRateFc":"2729.5","totalValueFC":"302878.9","currency":"USD","unitRateINR":"220953","date":"28-Jul-2022","totalValueINR":"24083880","totalValueInUsd":"302878.9","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29362100","bill_no":"1000264","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"DIREZIONE E UFFICI STRADA RIVOLTANA KM 6\/7 20090 RODANO (MI) IT","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669314600,"product":"ISOTRETINOIN","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"85.00","actualQuantity":"85","unit":"KGS","unitRateFc":"2300","totalValueFC":"197865.1","currency":"USD","unitRateINR":"189980","date":"25-Nov-2022","totalValueINR":"16148300","totalValueInUsd":"197865.1","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29362100","bill_no":"1001510","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"N\/A","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669573800,"product":"ISOTRETINOIN","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"32.00","actualQuantity":"32","unit":"KGS","unitRateFc":"2300","totalValueFC":"74490.4","currency":"USD","unitRateINR":"189980","date":"28-Nov-2022","totalValueINR":"6079360","totalValueInUsd":"74490.4","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29362100","bill_no":"1001514","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"N\/A","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671042600,"product":"ISOTRETINOIN","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"HANGZHOU YOUNGCHEM BIOTECH ","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"760","totalValueFC":"88754.3","currency":"USD","unitRateINR":"73139.1","date":"15-Dec-2022","totalValueINR":"7313913.24","totalValueInUsd":"88754.3","indian_port":"BOMBAY AIR","hs_no":"29362390","bill_no":"3753709","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673029800,"product":"ISOTRETINOIN (QTY-8.54 KGS X 2300 USD)","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"8.54","actualQuantity":"8.54","unit":"KGS","unitRateFc":"2300","totalValueFC":"20108.2","currency":"USD","unitRateINR":"192510","date":"07-Jan-2023","totalValueINR":"1644035.4","totalValueInUsd":"20108.2","indian_port":"HYDERABAD AIR","hs_no":"29362990","bill_no":"4071900","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678905000,"product":"ISOTRETINOIN","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"2000","totalValueFC":"40607.7","currency":"USD","unitRateINR":"167000","date":"16-Mar-2023","totalValueINR":"3340000","totalValueInUsd":"40607.7","indian_port":"HYDERABAD AIR","hs_no":"29362100","bill_no":"5080076","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681324200,"product":"ISOTRETINOIN (LICENCE VALID UP TO 30 JUN 2025)","address":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3","city":"","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"SYNGENE INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"1885","totalValueFC":"7622.5","currency":"USD","unitRateINR":"156172.3","date":"13-Apr-2023","totalValueINR":"624689","totalValueInUsd":"7622.5","indian_port":"Biocon-SEZ","hs_no":"29362990","bill_no":"1005032","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"N\/A","customerAddress":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682274600,"product":"ISOTRETINOIN USP\/EP CURRENT EDITION (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"303.00","actualQuantity":"303","unit":"KGS","unitRateFc":"1999.3","totalValueFC":"614642.4","currency":"USD","unitRateINR":"166245.1","date":"24-Apr-2023","totalValueINR":"50372270","totalValueInUsd":"614642.4","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29362100","bill_no":"1000196","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM 6\/7 20090 RODANO(MI) Milano, ITALY 0 ITALY","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686853800,"product":"ISOTRETINOIN USP\/EP (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"301.00","actualQuantity":"301","unit":"KGS","unitRateFc":"1999.8","totalValueFC":"608191.9","currency":"USD","unitRateINR":"166083.4","date":"16-Jun-2023","totalValueINR":"49991117","totalValueInUsd":"608191.9","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29362100","bill_no":"1000303","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"Strada Rivoltana km 6\/7 Rodano, milano 20090","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688409000,"product":"ISOTRETINOIN IP","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"HANGZHOU YOUNGCHEM BIOTECH","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"130.00","actualQuantity":"130","unit":"KGS","unitRateFc":"800","totalValueFC":"118272.1","currency":"USD","unitRateINR":"74775.1","date":"04-Jul-2023","totalValueINR":"9720725.987","totalValueInUsd":"118272.1","indian_port":"BOMBAY AIR","hs_no":"29362390","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691346600,"product":"ISOTRETINOIN USP (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"202.00","actualQuantity":"202","unit":"KGS","unitRateFc":"2000.5","totalValueFC":"407825.5","currency":"USD","unitRateINR":"167241.4","date":"07-Aug-2023","totalValueINR":"33782760","totalValueInUsd":"407825.5","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29362100","bill_no":"1000406","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"Strada Rivoltana km 6\/7 Rodano, milano 20090","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692642600,"product":"ISOTRETINOIN IP","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL","city":"MUMBAI","supplier":"HANGZHOU YOUNGCHEM BIOTECH","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"800","totalValueFC":"130618.2","currency":"USD","unitRateINR":"71411.6","date":"22-Aug-2023","totalValueINR":"10819934.45","totalValueInUsd":"130618.2","indian_port":"SAHAR AIR","hs_no":"29362390","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703529000,"product":"ISOTRETINOIN UPS\/EP (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"148.00","actualQuantity":"148","unit":"KGS","unitRateFc":"2000.9","totalValueFC":"298110.9","currency":"USD","unitRateINR":"167673.6","date":"26-Dec-2023","totalValueINR":"24815694","totalValueInUsd":"298110.9","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29362100","bill_no":"1000663","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"DIREZIONE E UFFICI: STR RIVOLTANA KM 6\/7 20090 RODANO (MI ) ITALY","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705516200,"product":"ISOTRETINOIN","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"135.00","actualQuantity":"135","unit":"KGS","unitRateFc":"2000","totalValueFC":"273697.9","currency":"USD","unitRateINR":"168500","date":"18-Jan-2024","totalValueINR":"22747500","totalValueInUsd":"273697.9","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29362100","bill_no":"1000064","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"N\/A","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707244200,"product":"ISOTRETINOIN IP","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"HANGZHOU YOUNGCHEM BIOTECH","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"800","totalValueFC":"92793.4","currency":"USD","unitRateINR":"76994.2","date":"07-Feb-2024","totalValueINR":"7699417.25","totalValueInUsd":"92793.4","indian_port":"Bombay Air","hs_no":"29362390","bill_no":"2018521","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"CO., LTDNO.217 MINLE ROAD, XINGHUODEVELOPMENT ZONE, FENGXIAN CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709058600,"product":"ISOTRETINOIN","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CHONGQING HUAPONT PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"23.00","actualQuantity":"23","unit":"KGS","unitRateFc":"2300","totalValueFC":"53490.5","currency":"USD","unitRateINR":"192970","date":"28-Feb-2024","totalValueINR":"4438310","totalValueInUsd":"53490.5","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29362100","bill_no":"1000258","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"N\/A","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709231400,"product":"ISOTRETINOIN PH.EUR","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"HANGZHOU NEOSTEROL BIOCHEM ","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"2500","totalValueFC":"30312.2","currency":"USD","unitRateINR":"209750","date":"01-Mar-2024","totalValueINR":"2517000","totalValueInUsd":"30312.2","indian_port":"Delhi Air","hs_no":"29362100","bill_no":"2385905","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"R802 UNIT BUILDING NO.11 VANKELIGHT OF CITY TONG YUN STREET YUHANGZHOU SDNF","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710181800,"product":"ISOTRETINOIN USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"8.74","actualQuantity":"8.74","unit":"KGS","unitRateFc":"3200","totalValueFC":"30953.6","currency":"EUR","unitRateINR":"294080","date":"12-Mar-2024","totalValueINR":"2570259.2","totalValueInUsd":"30953.6","indian_port":"Bombay Air","hs_no":"29362100","bill_no":"2540010","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STR. RIVOLTANA KM 6\/7 20090 RODANO(MI) MILAN, , ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715625000,"product":"ISOTRETINOIN USP\/EP (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"201.00","actualQuantity":"201","unit":"KGS","unitRateFc":"2004.3","totalValueFC":"407672.9","currency":"USD","unitRateINR":"169060.9","date":"14-May-2024","totalValueINR":"33981241","totalValueInUsd":"407672.9","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29362100","bill_no":"1000254","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"DIREZIONE E UFFICI: STR RIVOLTANA KM 6\/7 20090 RODANO (MI ) ITALY","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722018600,"product":"ISOTRETINOIN USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"38.05","actualQuantity":"38.045","unit":"KGS","unitRateFc":"3200","totalValueFC":"135010.5","currency":"EUR","unitRateINR":"296640","date":"27-Jul-2024","totalValueINR":"11285668.8","totalValueInUsd":"135010.5","indian_port":"Bombay Air","hs_no":"29362100","bill_no":"4742015","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STR. RIVOLTANA KM 6\/7 20090 RODANO(MI) MILAN, , ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATES SUPPLIERS

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

01

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

02

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

03

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

04

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

05

Douglas CDMO

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Contact Supplier

New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

Corporate PDF

06

Douglas CDMO

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Contact Supplier

New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

Corporate PDF

07

Douglas CDMO

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Contact Supplier

New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

Corporate PDF

08

Douglas CDMO

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Contact Supplier

New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

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09

Douglas CDMO

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

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10

Pharmathen SA

Greece

Pharma, Lab & Chemical Expo

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Greece

Virtual Booth

Digital Content

Regulatory Info : EU Approved

Registration Country : Greece

Isotretinoin

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Dosage Form : Soft Gel Capsule

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

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FDA Orange Book

01

ACTAVIS LABS FL

Ireland

Pharma, Lab & Chemical Expo

Not Confirmed

02

ACTAVIS LABS FL

Ireland

Pharma, Lab & Chemical Expo

Not Confirmed

03

AUROBINDO PHARMA

India

Israel

Pharma, Lab & Chemical Expo

Not Confirmed

07

UPSHER SMITH LABS

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

08

UPSHER SMITH LABS

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

09

DR REDDYS LABS LTD

Gabon

Pharma, Lab & Chemical Expo

Not Confirmed

10

DR REDDYS LABS LTD

Gabon

Pharma, Lab & Chemical Expo

Denmark

Pharma, Lab & Chemical Expo

Not Confirmed

04

PIERRE FABRE ITALIA SpA

France

Italy

Pharma, Lab & Chemical Expo

Not Confirmed

08

Sandoz Pharmaceuticals AG

Switzerland

Pharma, Lab & Chemical Expo

Not Confirmed

09

Sandoz Pharmaceuticals AG

Switzerland

Pharma, Lab & Chemical Expo

Not Confirmed

10

2care4 ApS

Country

Pharma, Lab & Chemical Expo

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Listed Dossiers

01

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

02

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

03

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

04

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Isotretinoin

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Product Web Link

05

Douglas Pharmaceuticals Ltd.

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

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06

Douglas Pharmaceuticals Ltd.

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

Corporate PDF

07

Douglas Pharmaceuticals Ltd.

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Contact Supplier

New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

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08

Douglas Pharmaceuticals Ltd.

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Contact Supplier

New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

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09

Douglas Pharmaceuticals Ltd.

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Contact Supplier

New Zealand

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : New Zealand

Isotretinoin

Brand Name :

Dosage Form : SOFT GEL CAPSULES

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

Corporate PDF

10

Pharmathen SA

Greece

Pharma, Lab & Chemical Expo

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Greece

Virtual Booth

Digital Content

Regulatory Info : EU Approved

Registration Country : Greece

Isotretinoin

Brand Name :

Dosage Form : Soft Gel Capsule

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 10MG

USFDA APPLICATION NUMBER - 21951

DOSAGE - CAPSULE;ORAL - 20MG

USFDA APPLICATION NUMBER - 21951

DOSAGE - CAPSULE;ORAL - 25MG

USFDA APPLICATION NUMBER - 21951

DOSAGE - CAPSULE;ORAL - 30MG

USFDA APPLICATION NUMBER - 21951

DOSAGE - CAPSULE;ORAL - 35MG

USFDA APPLICATION NUMBER - 21951

DOSAGE - CAPSULE;ORAL - 40MG

USFDA APPLICATION NUMBER - 21951

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Chewable & Orodispersible Aids

01

Rochem International Inc

U.S.A

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

Brand Name : Sorbitol

Application : Taste Masking

Excipient Details : Sorbitol’s bulk sweetness and compatibility with active ingredients makes it an ideal taste masking agent in pharmaceutical formulations.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Sorbitol

02

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Compressol SM

Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, lower disintegration time & hygroscopicity

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

Shijiazhuang Huaxu Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

04

Zhejiang Huakang Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

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Soft Gelatin

Disintegrants & Superdisintegrants

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DATA COMPILATION #PharmaFlow

J&J’s diabetes drug reduces heart risk at the cost of toes; Google’s AI eye doctor initiative

This week in Phispers, we bring you news on J&J’s Invokana, a drug that reduces heart risk while increasing the risk of amputation of toes. There is news from Google, which is tying up with India’s Aravind Eye Care System for its artificial intelligence eye doctor initiative. And WHO takes a step towards reducing antibiotic resistance by grouping antibiotics into ‘Access’, ‘Watch’ and ‘Reserve’. Manufacturing errors trigger drug recalls by Lupin and Dr. Reddy’s in the US Earlier this month, we carried an article on the end of India’s pharma honeymoon. News this week from Lupin and Cipla added another dimension to the problem as manufacturing errors triggered drug recalls in the United States. Lupin voluntarily recalled a lot of its birth control pills — Mibelas 24 Fe — in the US. A market complaint indicated a packaging error, making the lot number and expiration date no longer visible. This product is an oral contraceptive for women. As a result of the packaging error, the FDA says the first four days of the birth control packet have four non-hormonal placebo tablets as opposed to the active tablets. This may place the user at risk for contraceptive failure and unintended pregnancy. Similarly, Dr. Reddy’s had to recall hundreds of thousands of cartons of a popular acne medicine — Zenatane — manufactured by Cipla’s plant in Pune. According to FDA enforcement reports, Dr. Reddy’s is recalling 190 lots, consisting of 778,279 cartons of its Zenatane brand isotretinoin capsules, in four dose sizes. The voluntary Class II recall was initiated in late May after the products failed dissolution testing. During this period of turmoil, the Indian company which is generating a lot of positive press is Cadila Healthcare. Cadila’s US division Zydus Pharmaceuticals’ subsidiary Nesher Pharmaceuticals has received final FDA approval to market Nystatin Topical Powder, an anti-fungal antibiotic used to treat skin infections caused by yeast. There is more good news from Zydus Cadila. After years of patent battles, the FDA has approved Zydus Cadila’s generic version of Shire’s ulcerative colitis drug Lialda. This came as a rude shock to Shire investors who had believed the US$ 800 million drug was safe for a few more years. However, there is a chance that instead of a flood of generics, the Zydus' generic may be the only competition for Lialda for sometime. Zydus Cadilla has indicated that its version will have a six-month exclusivity. J&J’s diabetes drug saves heart at the cost of toes; Sanofi’s insulin slashes hypoglycemia risks for seniors Would you like to sacrifice your toes to save yourself from a heart attack? Well, a diabetes drug made by Johnson & Johnson (J&J), does just that. The drug — Invokana — decreases the risk of heart attacks and strokes, while increasing the risk of amputation, particularly of toes. According to the results of the 10,142-patient study, funded by J&J, for every three heart attacks, strokes, or cardiovascular deaths prevented by Invokana, there were two amputations, 71 percent of them of toes or the lower foot. While this is a setback to J&J, its rivals — Eli Lilly and Boehringer Ingelheim — who make a similar drug called Jardiance, may be cheering the findings of this study, performed on sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs prevent the kidney from absorbing sugar from the blood. But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” Harlan Krumholz of Yale University said. Another study examining an at-risk population of seniors who had switched to basal insulin found Sanofi’s Toujeo to outdo its peers at cutting the risk of hypoglycemia in older patients. During a six-month follow-up, the study found that amongst the ‘at-risk’ seniors, those taking Toujeo were 57 percent less likely to experience hypoglycemia than those who switched to competing insulins—such as Novo Nordisk’s Tresiba and Levemir, and Toujeo’s predecessor, Lantus. Google ties up with Indian hospital chain for artificial intelligence eye doctor initiative Google will soon begin work on a grand experiment that would use machines to widen access of healthcare. If successful, this initiative will protect millions of diabetes patients from an eye disease that leads to blindness. Last year, researchers at Google had said they had trained image recognition algorithms to detect signs of diabetic retinopathy roughly as accurately as human experts. Left untreated, diabetic retinopathy causes blindness. The software examines photos of a patient’s retina to spot tiny aneurisms that would help detect early stages of the disease. Google is working with the Aravind Eye Care System in India, a network of eye hospitals, in order to integrate this technology. “This kind of blindness is completely preventable, but because people can’t get screened, half suffer vision loss before they’re detected,” Lily Peng, a product manager with the Google Brain AI research group, said. “One of the promises of this technology is being able to make healthcare more accessible.” There are more than 400 million people worldwide with diabetes, including 70 million in India. FDA tells Endo to pull out its opioid pain medication, as Gottlieb attacks addiction Last week, the US FDA asked drugmaker Endo Pharmaceuticals to remove its powerful opioid pain medication — Opana ER — from the market, due to “the public health consequences of abuse”. “We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” he added. Opioid overdoses killed 33,000 Americans in 2015, with half of those involving a prescription opioid. Opana ER, which is oxymorphone hydrochloride, is used to manage severe pain. The FDA approved it for this use in 2006. The drug is about twice as powerful as OxyContin, another often abused opioid. In 2012, Endo reformulated the drug to make it more resistant to physical and chemical tampering. While the drug met the standards for approval, FDA says Endo never showed that the reformulation would reduce abuse. Amgen loses bid to delay Novartis’ biosimilar; FDA rejects Coherus’ biosimilar for Neulasta Amgen lost a case in the Supreme Court of the United States that sought to delay biosimilars of its rivals. Amgen had argued that its biosimilar rivals should be forced to delay their 180-day marketing notices until the FDA had made up its mind on the marketing application. However, on Monday, the Supreme Court took a decision by determining that the law never imposed a two-tier timing system for these notices. Therefore “the applicant may provide notice either before or after receiving FDA approval.” This has proven to be a clear win for Sandoz — the generic unit of Novartis that is fielding an array of copycat biologics. The group is launching a copy of Amgen’s Neupogen. And in the process, Sandoz has unleashed a fresh wave of biosimilars hitting the US market. However, Amgen won somewhere else — the FDA rejected Coherus Biosciences’ application for a biosimilar of Amgen’s blockbuster Neulasta (a drug that fights infections in cancer patients). This action effectively delays any rival until 2018, at the earliest. The FDA's response comes as Amgen gears up for biosimilar competition for Neulasta, which generated about US$ 4.6 billion in sales last year. The FDA requested Coherus for a re-analysis of certain data and asked the drug developer for more manufacturing information. WHO updates list of essential medicines; groups antibiotics into three categories Last week, the World Health Organization (WHO) released its Essential Medicines List (EML), with a new advice on which antibiotics to use for common infections and which to preserve for serious circumstances. Amongst the additions to the WHO Model list of essential medicines for 2017 are medicines for HIV, hepatitis C, tuberculosis and leukaemia. The EML is used by many countries to increase access to medicines. The updated list has added 30 drugs for adults and 25 for children, and specifies new uses for 9 already-listed products. In all, it contains 433 drugs deemed essential to address the most important public health needs. This time, WHO has grouped antibiotics into three categories – ACCESS, WATCH and RESERVE – with recommendations on when each category should be used. Initially, the new categories apply only to antibiotics used to treat 21 of the most common general infections. If found useful, it could be broadened in future versions of the EML to apply to drugs to treat other infections. Antibiotics in the ACCESS group must be available at all times as treatments for a wide range of common infections. It includes drugs like amoxicillin, an antibiotic used to treat infections such as pneumonia. The WATCH group includes antibiotics that are recommended as first- or second-choice treatments for a small number of infections. For example, the use of ciprofloxacin, used to treat cystitis (a type of urinary tract infection) and upper respiratory tract infections (such as bacterial sinusitis and bacterial bronchitis), should be dramatically reduced to avoid further development of resistance. The third group, RESERVE, includes antibiotics that should be considered as last resorts, such as colistin and some cephalosporins. These must be used only in the most severe circumstances when all other alternatives have failed.

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Brand Name : Isotrex

United Kingdom

France

Duphat

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Market Place

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APIs

Isotretinoin (10 kg - 40 kg) API needed in India [ENA19304]

A CDMO that focuses on manufacturing and development of various finished formulations is looking for suppliers of Isotretinoin (10 kg - 40 kg) API for development purposes. The suppliers must support this enquiry with FDA dossier & CoA.

05 Apr 2024

Isotretinoin API needed in China [ENA18266]

A company that deals in various pharmaceutical products is looking for suppliers of Isotretinoin API for development purposes. The suppliers must support this enquiry with CoA.

09 Oct 2023

Isotretinoin API needed in Taiwan [ENA16650]

A company that focuses on research, development & manufacturing of tablets, capsules, semi-solid and liquids is looking for suppliers of Isotretinoin API. The required quantity is 1 kg - 5 kg for development & 25 kg for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.

18 Mar 2023

Isotretinoin (10 kg) API needed in Bangladesh [ENA16082]

A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Isotretinoin (10 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

13 Jan 2023

Isotretinoin API needed in India [ENA16047]

A CRO that focuses on the research and development of various finished formulations is looking for suppliers of Isotretinoin API for development purposes. The suppliers must support this enquiry with CEP & CoA.

10 Jan 2023

Isotretinoin (200 kg - 1 MT) API needed in Vietnam [ENA15601]

A company that deals in various pharmaceutical products is looking for suppliers of Isotretinoin (200 kg - 1 MT) API for commercial purposes. The suppliers must support this enquiry with GMP.

19 Nov 2022

BP Grade Isotretinoin API needed in India [ENA14027]

A research-based pharmaceutical organisation with over three decades of expertise in ophthalmology, ENT and dermatology formulations is looking for suppliers of BP Grade Isotretinoin API for development purpose. The suppliers must support this enquiry with DMF.

20 Jun 2022

Isotretinoin API needed in Greece [ENA13775]

A company that focused in the development, registration, manufacturing and life-cycle management of highly complex pharmaceutical technologies and generic formulations is looking for suppliers of Isotretinoin API.

27 May 2022

Isotretinoin (600 kg/ annum) API needed in Colombia [ENA11889]

A company based in Colombia that deals in the research, development, manufacturing & marketing of pharmaceutical formulations is looking for suppliers of Isotretinoin (600 kg/ annum) API for commercial purpose. The suppliers must support this enquiry with GMP & CoA.

18 Nov 2021

Various APIs needed in Vietnam [ENA11179]

Can Alliance Group, a trading and distributing company that deals in active pharmaceutical ingredients, herbal, nutraceutical and cosmetic ingredients is looking for suppliers of Various APIs. The suppliers must support this enquiry with CoA, GMP & DMF (open part). Interested suppliers can contact them via their email: erin@cangroup.com.sg. 1. Ledipasvir (10 kg) API 2. Velpatasvir (5 kg) API 3. Valproate Sodium (200 kg) API 4. Isotretinoin (5 kg) API

21 Aug 2021

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ABOUT THIS PAGE

Isotretinoin Manufacturers

A Isotretinoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isotretinoin, including repackagers and relabelers. The FDA regulates Isotretinoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isotretinoin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Isotretinoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Isotretinoin Suppliers

A Isotretinoin supplier is an individual or a company that provides Isotretinoin active pharmaceutical ingredient (API) or Isotretinoin finished formulations upon request. The Isotretinoin suppliers may include Isotretinoin API manufacturers, exporters, distributors and traders.

click here to find a list of Isotretinoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Isotretinoin USDMF

A Isotretinoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Isotretinoin active pharmaceutical ingredient (API) in detail. Different forms of Isotretinoin DMFs exist exist since differing nations have different regulations, such as Isotretinoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Isotretinoin DMF submitted to regulatory agencies in the US is known as a USDMF. Isotretinoin USDMF includes data on Isotretinoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isotretinoin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Isotretinoin suppliers with USDMF on PharmaCompass.

Isotretinoin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Isotretinoin Drug Master File in Korea (Isotretinoin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isotretinoin. The MFDS reviews the Isotretinoin KDMF as part of the drug registration process and uses the information provided in the Isotretinoin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Isotretinoin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Isotretinoin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Isotretinoin suppliers with KDMF on PharmaCompass.

Isotretinoin CEP

A Isotretinoin CEP of the European Pharmacopoeia monograph is often referred to as a Isotretinoin Certificate of Suitability (COS). The purpose of a Isotretinoin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isotretinoin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isotretinoin to their clients by showing that a Isotretinoin CEP has been issued for it. The manufacturer submits a Isotretinoin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isotretinoin CEP holder for the record. Additionally, the data presented in the Isotretinoin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isotretinoin DMF.

A Isotretinoin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isotretinoin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Isotretinoin suppliers with CEP (COS) on PharmaCompass.

Isotretinoin WC

A Isotretinoin written confirmation (Isotretinoin WC) is an official document issued by a regulatory agency to a Isotretinoin manufacturer, verifying that the manufacturing facility of a Isotretinoin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Isotretinoin APIs or Isotretinoin finished pharmaceutical products to another nation, regulatory agencies frequently require a Isotretinoin WC (written confirmation) as part of the regulatory process.

click here to find a list of Isotretinoin suppliers with Written Confirmation (WC) on PharmaCompass.

Isotretinoin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Isotretinoin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Isotretinoin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Isotretinoin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Isotretinoin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isotretinoin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Isotretinoin suppliers with NDC on PharmaCompass.

Isotretinoin GMP

Isotretinoin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Isotretinoin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Isotretinoin GMP manufacturer or Isotretinoin GMP API supplier for your needs.

Isotretinoin CoA

A Isotretinoin CoA (Certificate of Analysis) is a formal document that attests to Isotretinoin's compliance with Isotretinoin specifications and serves as a tool for batch-level quality control.

Isotretinoin CoA mostly includes findings from lab analyses of a specific batch. For each Isotretinoin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Isotretinoin may be tested according to a variety of international standards, such as European Pharmacopoeia (Isotretinoin EP), Isotretinoin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isotretinoin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers

15 USDMF

10 CEP/COS

3 EU WC

3 KDMF

8 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

202 FDF Dossiers

58 FDA Orange Book

70 Europe

12 Canada

18 Australia

13 South Africa

31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG

CAPSULE;ORAL - 20MG

CAPSULE;ORAL - 25MG

CAPSULE;ORAL - 30MG

CAPSULE;ORAL - 35MG

CAPSULE;ORAL - 40MG

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1 Minakem

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5 Nanjing Well Pharmaceutical

4 ACG Worldwide

4 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 Finar

7 Gangwal Chemicals

1 Kerry

3 Lonza Capsugel

2 Microlex e.U

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1 Novo Excipients

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11 Roquette

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1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

1 Valens Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

22 Solubilizers

16 Fillers, Diluents & Binders

15 Parenteral

15 Film Formers & Plasticizers

12 Coating Systems & Additives

11 Topical

11 Thickeners and Stabilizers

10 Direct Compression

10 Emulsifying Agents

8 Empty Capsules

8 Granulation

7 Taste Masking

6 Controlled & Modified Release

5 Surfactant & Foaming Agents

4 Lubricants & Glidants

4 Co-Processed Excipients