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Egis Promethazine Hydrochloride

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 10 USDMF, 3 CEP/COS, 2 JDMF, 3 EU WC, 15 NDC API, 7 Listed Suppliers, $ API Reference Price

19 API Suppliers
10 USDMF
3 CEP/COS
2 JDMF
3 EU WC
15 NDC API
7 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 174 FDA Orange Book, 1 Europe, 4 Canada, 16 South Africa, 21 Listed Dossiers

216 FDF Dossiers
174 FDA Orange Book
1 Europe
4 Canada
16 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 25MG/ML, INJECTABLE;INJECTION - 50MG/ML, SYRUP;ORAL - 6.25MG/5ML, SYRUP;ORAL - 5MG/5ML;6.25MG/5ML, SYRUP;ORAL - 10MG/5ML;6.25MG/5ML

drugProductComposition
INJECTABLE;INJECTION - 25MG/ML
INJECTABLE;INJECTION - 50MG/ML
SYRUP;ORAL - 6.25MG/5ML
SYRUP;ORAL - 5MG/5ML;6.25MG/5ML
SYRUP;ORAL - 10MG/5ML;6.25MG/5ML

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 3 SPI Pharma, 18 DKSH, 2 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 11 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 12 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 30 Thickeners and Stabilizers, 28 Direct Compression, 23 Controlled & Modified Release, 19 Solubilizers, 19 Film Formers & Plasticizers, 17 Parenteral, 17 Lubricants & Glidants, 17 Co-Processed Excipients, 16 Disintegrants & Superdisintegrants, 15 Granulation, 15 Taste Masking, 11 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Rheology Modifiers, 5 Chewable & Orodispersible Aids, 4 Coloring Agents, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

13 NEWS #PharmaBuzz

media
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

22 Finished Drug Prices

globalSalesInformation
22 Finished Drug Prices

MARKET PLACE

29 APIs, 2 FDF Dossiers

marketPlace
29 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 1 Others

otherSolutions
3 EDQM
1 USP
1 Others

Egis Promethazine Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

19

API Suppliers

10

USDMF

3

CEP/COS

CEP/COS Certifications

2

JDMF

3

EU WC

0

KDMF

15

NDC API

0

VMF

7

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 61

MARKET PLACE

29

API

2

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

216

FDF Dossiers

174

FDA Orange Book

FDA (Orange Book)

1

Europe

4

Canada

0

Australia

16

South Africa

21

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

3

EDQM

1

USP

0

JP

1

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

13

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

NA

Annual Reports (USD Million)

NA

Finished Drug Prices

245 RELATED EXCIPIENT COMPANIES

386EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

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Also known as: 58-33-3, Promethazine hcl, Phenergan, N,n-dimethyl-1-(10h-phenothiazin-10-yl)propan-2-amine hydrochloride, Fenergan, Remsed

Molecular Formula

C₁₇H₂₁ClN₂S

Molecular Weight

320.9 g/mol

InChI Key

XXPDBLUZJRXNNZ-UHFFFAOYSA-N

FDA UNII

R61ZEH7I1I

Promethazine Hydrochloride

A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals.

1 2D Structure

Promethazine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N,N-dimethyl-1-phenothiazin-10-ylpropan-2-amine;hydrochloride

2.1.2 InChI

InChI=1S/C17H20N2S.ClH/c1-13(18(2)3)12-19-14-8-4-6-10-16(14)20-17-11-7-5-9-15(17)19;/h4-11,13H,12H2,1-3H3;1H

2.1.3 InChI Key

XXPDBLUZJRXNNZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(CN1C2=CC=CC=C2SC3=CC=CC=C31)N(C)C.Cl

2.2 Other Identifiers

2.2.1 UNII

R61ZEH7I1I

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Atosil

2. Diphergan

3. Diprazin

4. Hydrochloride, Promethazine

5. Isopromethazine

6. Phenargan

7. Phenergan

8. Phensedyl

9. Pipolfen

10. Pipolphen

11. Proazamine

12. Promet

13. Prometazin

14. Promethazine

15. Prothazin

16. Pyrethia

17. Remsed

18. Rumergan

2.3.2 Depositor-Supplied Synonyms

1. 58-33-3

2. Promethazine Hcl

3. Phenergan

4. N,n-dimethyl-1-(10h-phenothiazin-10-yl)propan-2-amine Hydrochloride

5. Fenergan

6. Remsed

7. Promethazine (hydrochloride)

8. Diprasine

9. Diprazin

10. Fellozine

11. Pipolfen

12. Pipolphen

13. Ganphen

14. Plletia

15. Prometh Fortis

16. Prometh Plain

17. Promethazine.hcl

18. Mymethazine Fortis

19. Anergan 25

20. Promethacon

21. Promethegan

22. Romergan

23. Promethazine Chloride

24. Promethiazin

25. Zipan-25

26. V Gan

27. Lergigan

28. Pyrethia

29. Zipan-50

30. Promethazine Monohydrochloride

31. Hl 8700

32. N-(2-dimethylaminopropyl-1)phenothiazine Hydrochloride

33. 10-[2-(dimethylamino)propyl]phenothiazine Hydrochloride

34. N,n-dimethyl-1-phenothiazin-10-ylpropan-2-amine;hydrochloride

35. N-(2'-dimethylamino-2'-methyl)ethylphenothiazine Hydrochloride

36. R61zeh7i1i

37. 10-(3-dimethylaminoisopropyl)phenothiazine Hydrochloride

38. 3277 R.p.

39. Mls000069398

40. 10-(2-dimethylamino-1-propyl)phenothiazine Hydrochloride

41. Chebi:8462

42. Farganesse

43. Avomine

44. Nsc-231688

45. 58-33-3 (hcl)

46. Allerfen

47. Duplamin

48. Frinova

49. Goodnight

50. Hibechin

51. Histantil

52. Kinetosin

53. Phenadoz

54. Phencen

55. Primine

56. Promantine

57. Promine

58. Proneurin

59. Smr000058379

60. Soporil

61. Bonnox

62. Closin

63. Dorme

64. Prome

65. (+-)-10-(2-(dimethylamino)propyl)phenothiazine Monohydrochloride

66. Eusedon Mono

67. Phenergan Fortis

68. Dsstox_cid_1192

69. Pms Promethazine

70. Promethazine Plain

71. Dsstox_rid_76002

72. Dsstox_gsid_21192

73. 1435933-86-0

74. Anergan 50

75. Promethazine Hydrochloride 100 Microg/ml In Acetonitrile

76. Phenergan Plain

77. Promethiazin [german]

78. Ccris 5873

79. Phenergan Hydrochloride

80. Promethazine Hydrochloride [jan]

81. Promethazinehydrochloride

82. Einecs 200-375-2

83. Mfcd00012652

84. Unii-r61zeh7i1i

85. Nsc 231688

86. Genphen

87. Sr-01000002993

88. Phanergan D

89. Phenergan (tn)

90. Promethegan (tn)

91. 10-(2-dimethylaminopropyl)phenothiazine Hydrochloride

92. Component Of Mepergan

93. Promethazine Hydrochloride [usp:jan]

94. Promethazine-d3 Hcl

95. 10-(2-(dimethylamino)propyl)phenothiazine Monohydrochloride

96. Cpd000058379

97. Phenothiazine, 10-(2-(dimethylamino)-propyl)-, Hydrochloride

98. Pronase [jan]

99. Promethazine Hydrochlorine

100. Cas-58-33-3

101. Opera_id_1745

102. 10h-phenothiazine-10-ethanamine, N,n,alpha-trimethyl-, Monohydrochloride

103. Diprazinum [who-ip]

104. Schembl41904

105. Mls001074184

106. Mls002548850

107. Spectrum1500510

108. Chembl1200750

109. Dtxsid3021192

110. Promethazine Hydrochloride Solution

111. Hms1570b18

112. Hms1920l16

113. Pharmakon1600-01500510

114. Hy-b0781

115. N,n-dimethyl-1-phenothiazin-10-yl-propan-2-amine Hydrochloride

116. Phenothiazine, 10-(2-(dimethylamino)propyl)-, Monohydrochloride

117. Promethazine For Peak Identification

118. Tox21_202264

119. Tox21_302878

120. Tox21_500899

121. Nsc231688

122. Nsc757301

123. S4293

124. 10h-phenothiazine-10-ethanamine, N,n,.alpha.-trimethyl-, Monohydrochloride

125. Akos016339657

126. Ccg-207895

127. Cs-3543

128. Ks-1385

129. Lp00899

130. Nc00471

131. Nsc-757301

132. Promethazine Hydrochloride (jp17/usp)

133. Promethazine Hydrochloride [mi]

134. Rp-3389

135. 10h-phenothiazine-10-ethanamine, N,n,alpha-trimethyl-, Monohydrochloride, (+-)-

136. Ncgc00089735-04

137. Ncgc00094215-01

138. Ncgc00094215-02

139. Ncgc00094215-03

140. Ncgc00094215-04

141. Ncgc00094215-05

142. Ncgc00256588-01

143. Ncgc00259813-01

144. Ncgc00261584-01

145. Ac-12482

146. Bp166198

147. Promethazine Hydrochloride [mart.]

148. Promethazine Hydrochloride [vandf]

149. Promethazine Hydrochloride [usp-rs]

150. Promethazine Hydrochloride [who-dd]

151. Promethazine Hydrochloride [who-ip]

152. Db-053186

153. Eu-0100899

154. P2029

155. Sw197234-3

156. D00480

157. D92182

158. P 4651

159. Promethazine Hydrochloride [orange Book]

160. Promethazine Hydrochloride [ep Monograph]

161. Promethazine Hydrochloride [usp Impurity]

162. Wln: T C666 Bn Isj B1y1&n1&1 &gh

163. A831833

164. Promethazine Hydrochloride [usp Monograph]

165. Promethazini Hydrochloridum [who-ip Latin]

166. Mepergan Component Promethazine Hydrochloride

167. Sr-01000002993-2

168. Sr-01000002993-7

169. W-105399

170. Promethazine Hydrochloride Component Of Mepergan

171. Q27108086

172. F0138-3355

173. Phenergan Vc Component Promethazine Hydrochloride

174. Pherazine Dm Component Promethazine Hydrochloride

175. Pherazine Vc Component Promethazine Hydrochloride

176. Z1259273234

177. ((c)i)-promethazine-d4 Hcl (phenothiazine-1,3,7,9-d4)

178. Promethazine Dm Component Promethazine Hydrochloride

179. Promethazine Hydrochloride Component Of Phenergan Vc

180. Promethazine Hydrochloride Component Of Pherazine Dm

181. Promethazine Hydrochloride Component Of Pherazine Vc

182. Promethazine Vc Component Promethazine Hydrochloride

183. N,n-dimethyl-1-(10-phenothiazinyl)-2-propanamine Hydrochloride

184. N-(2'-dimethylamino-2'-methylaethyl)-phenothiazin Hydrochlorid

185. N-(2'-dimethylamino-2-methylethyl)phenothiazine Hydrochloride

186. Promethazine Hydrochloride Component Of Promethazine Dm

187. Promethazine Hydrochloride Component Of Promethazine Vc

188. Promethazine Hydrochloride, Vetranal(tm), Analytical Standard

189. N,n-dimethyl-1-phenothiazin-10-ylpropan-2-amine;hydron;chloride

190. (+/-)-10-(2-(dimethylamino)propyl)phenothiazine Monohydrochloride

191. 10h-phenothiazine-10-ethanamine,n,.alpha.-trimethyl-, Monohydrochloride

192. Dimethyl[1-(10h-phenothiazin-10-yl)propan-2-yl]amine Hydrochloride

193. N,n-dimethyl-1-(10h-phenothiazin-10-yl)-2-propanamine Hydrochloride

194. Promethazine Hydrochloride 1.0 Mg/ml In Dimethyl Sulfoxide (as Free Base)

195. Promethazine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

196. Promethazine Hydrochloride, Vial Of 25 Mg, Certified Reference Material

197. 10h-phenothiazine-10-ethanamine, N,n,.alpha.-trimethyl-, Monohydrochloride, (+/-)-

198. 10h-phenothiazine-10-ethanamine, N,n,alpha-trimethyl-, Hydrochloride (1:1)

199. Promethazine For Peak Identification, European Pharmacopoeia (ep) Reference Standard

200. Promethazine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

201. Promethazine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₂₁ClN₂S
Molecular Weight	320.9 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	320.1113975 g/mol
Monoisotopic Mass	320.1113975 g/mol
Topological Polar Surface Area	31.8 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	298
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Promethazine hydrochloride
Drug Label	DESCRIPTIONPromethazine hydrochloride is a racemic compound.Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,-trimethyl-, monohydrochloride, ()-with the following structural...
Active Ingredient	Promethazine hydrochloride
Dosage Form	Tablet; Syrup; Suppository; Injectable
Route	Rectal; Injection; Oral
Strength	25mg; 50mg/ml; 25mg/ml; 6.25mg/5ml; 50mg; 12.5mg
Market Status	Prescription
Company	Vintage Pharms; Amneal Pharms; Wockhardt; Hospira; Sun Pharm Inds; Teva Pharms Usa; Taro; Sandoz; Watson Labs; Amneal Pharms Ny; Hi Tech Pharma; Caraco; Hikma Maple; Kvk Tech; X-gen Pharms; Vintage; Emcure Pharms Usa; Perrigo New York; Luitpold; Zydus Pha

2 of 4
Drug Name	Promethazine plain
Active Ingredient	Promethazine hydrochloride
Dosage Form	Syrup
Route	Oral
Strength	6.25mg/5ml
Market Status	Prescription
Company	Wockhardt

3 of 4
Drug Name	Promethazine hydrochloride
Drug Label	DESCRIPTIONPromethazine hydrochloride is a racemic compound.Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,-trimethyl-, monohydrochloride, ()-with the following structural...
Active Ingredient	Promethazine hydrochloride
Dosage Form	Tablet; Syrup; Suppository; Injectable
Route	Rectal; Injection; Oral
Strength	25mg; 50mg/ml; 25mg/ml; 6.25mg/5ml; 50mg; 12.5mg
Market Status	Prescription
Company	Vintage Pharms; Amneal Pharms; Wockhardt; Hospira; Sun Pharm Inds; Teva Pharms Usa; Taro; Sandoz; Watson Labs; Amneal Pharms Ny; Hi Tech Pharma; Caraco; Hikma Maple; Kvk Tech; X-gen Pharms; Vintage; Emcure Pharms Usa; Perrigo New York; Luitpold; Zydus Pha

4 of 4
Drug Name	Promethazine plain
Active Ingredient	Promethazine hydrochloride
Dosage Form	Syrup
Route	Oral
Strength	6.25mg/5ml
Market Status	Prescription
Company	Wockhardt

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Allergic Agents

Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

Antipruritics

Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Phenothiazines [CS]; Phenothiazine [EPC]

API SUPPLIERS

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USDMF

01

Egis Pharmaceuticals Plc

Hungary

Duphat

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Contact Supplier

Contact Supplier

Hungary

Digital Content

PROMETHAZINE HCL

GDUFA

DMF Review : Complete

Rev. Date : 2021-06-10

Pay. Date : 2021-06-07

DMF Number : 7882

Submission : 1989-01-24

Status : Active

Type : II

Egis Pharmaceuticals

Product Web Link

Digital Content

02

Sanofi Winthrop Industrie

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

Contact Supplier

France

Digital Content

PROMETHAZINE HCL

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-13

DMF Number : 1949

Submission : 1972-06-09

Status : Active

Type : II

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

03

Emcure Pharmaceuticals Ltd

India

Duphat

Not Confirmed

04

Ipca Laboratories Ltd

India

Duphat

Not Confirmed

05

Loftus Bryan Chemicals Ltd

U.S.A

Duphat

Not Confirmed

06

Napp Chemicals Inc

U.S.A

Duphat

Not Confirmed

07

Sigma Aldrich Ireland Ltd

U.S.A

Duphat

Not Confirmed

08

Wanbury Ltd

India

Duphat

Not Confirmed

09

Zydus Lifesciences Ltd

India

Duphat

Not Confirmed

10

May And Baker Ltd

Country

Duphat

Not Confirmed

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CEP/COS

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JDMF

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Listed Suppliers

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API Reference Price

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HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"MEDREICH","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"227","totalValueFC":"18256.6","currency":"EUR","unitRateINR":"20259.8","date":"10-Oct-2023","totalValueINR":"1519481.25","totalValueInUsd":"18256.6","indian_port":"Bangalore Air","hs_no":"29359090","bill_no":"8230944","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1160 BUDAPEST KERESZTURI UT 30-38SDNFSDNF HUNGARY","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698690600,"product":"PROMETHAZINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"183","totalValueFC":"78583.1","currency":"EUR","unitRateINR":"16351.1","date":"31-Oct-2023","totalValueINR":"6540420","totalValueInUsd":"78583.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8554161","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1106 BUDAPEST KERESZTURI UT 30-38 KERESZTURI, HungarySDNF Hungary","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700591400,"product":"PROMETHAZINE HYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"228","totalValueFC":"25121.6","currency":"EUR","unitRateINR":"20919","date":"22-Nov-2023","totalValueINR":"2091900","totalValueInUsd":"25121.6","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"8876957","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1106 BUDAPEST KERESZTURI UT 30-38 ,, HUNGARYSDNF HUNGARY","customerAddress":"781, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702060200,"product":"PROMETHAZINE HYDROCHLORIDE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"MEDREICH","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"227","totalValueFC":"18683","currency":"EUR","unitRateINR":"20736.5","date":"09-Dec-2023","totalValueINR":"1555233.75","totalValueInUsd":"18683","indian_port":"Bangalore Air","hs_no":"29359090","bill_no":"9151659","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1160 BUDAPEST KERESZTURI UT 30-38SDNFSDNF HUNGARY","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702060200,"product":"PROMETHAZINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"N\/A","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"183","totalValueFC":"40164.4","currency":"EUR","unitRateINR":"16717.1","date":"09-Dec-2023","totalValueINR":"3343410","totalValueInUsd":"40164.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9150739","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST","supplierAddress":"N\/A","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706639400,"product":"PROMETHAZINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"11.72","actualQuantity":"11.72","unit":"KGS","unitRateFc":"183","totalValueFC":"2381.9","currency":"EUR","unitRateINR":"16890.9","date":"31-Jan-2024","totalValueINR":"197961.35","totalValueInUsd":"2381.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9911675","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1106 BUDAPEST KERESZTURI UT 30-38 KERESZTURI, , HungarySDNF Hungary","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718562600,"product":"PROMETHAZINE HYDROCHLORIDE","address":"SHANKAR TOWERS PLOT NO. A30,A.I.E","city":"HYDERABAD,TELANGANA","supplier":"SOLUPHARM PHARMAZEUTISCHE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ANTHEA PHARMA PVT LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"21","totalValueFC":"581.4","currency":"EUR","unitRateINR":"1941.5","date":"17-Jun-2024","totalValueINR":"48536.25","totalValueInUsd":"581.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4046736","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ERZEUGNISSE GMBH, INDUSTRIESTRASSE3, 34212 MELSUNGENSDNF GERMANY","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721413800,"product":"PROMETHAZINE HYDROCHLORIDE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"MEDREICH","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"227","totalValueFC":"12586.8","currency":"EUR","unitRateINR":"21042.9","date":"20-Jul-2024","totalValueINR":"1052145","totalValueInUsd":"12586.8","indian_port":"Bangalore Air","hs_no":"29359090","bill_no":"4623767","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1160 BUDAPEST KERESZTURI UT 30-38SDNFSDNF HUNGARY","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"PROMETHAZINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"183","totalValueFC":"81977.6","currency":"EUR","unitRateINR":"17174.6","date":"03-Sep-2024","totalValueINR":"6869820","totalValueInUsd":"81977.6","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5393069","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1106 BUDAPEST KERESZTURI UT 30-38 K ERESZTURI, , Hungary SDNF Hungary Hungary","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726597800,"product":"PROMETHAZINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"183","totalValueFC":"82763.7","currency":"EUR","unitRateINR":"17339.3","date":"18-Sep-2024","totalValueINR":"6935700","totalValueInUsd":"82763.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5668781","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"1106 BUDAPEST KERESZTURI UT 30-38 K ERESZTURI, , Hungary SDNF Hungary","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729362600,"product":"PROMETHAZINE HYDROCHLORIDE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"EGIS PHARMACEUTICALS PLC","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"MEDREICH","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"227","totalValueFC":"12555.3","currency":"EUR","unitRateINR":"21099.7","date":"20-Oct-2024","totalValueINR":"1054982.5","totalValueInUsd":"12555.3","indian_port":"Bangalore Air","hs_no":"29359090","bill_no":"6231503","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST","supplierAddress":"1106 BUDAPEST KERESXTURI UT 30-38 H UNGARY HUNGARY","customerAddress":"MEDREICH HOUSE, NO12\/8,"}]

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

01

ANI Pharmaceuticals Inc

U.S.A

Duphat

Not Confirmed

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FDF Dossiers

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FDA Orange Book

01

STRIDES PHARMA

India

Duphat

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

Contact Supplier

India

Digital Content

RLD : No

TE Code : AB

PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Approval Date : 2017-06-30

Application Number : 209177

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

Product Web Link

Digital Content

02

STRIDES PHARMA

India

Duphat

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

Contact Supplier

India

Digital Content

RLD : No

TE Code : AB

PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2017-06-30

Application Number : 209177

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

Product Web Link

Digital Content

03

STRIDES PHARMA

India

Duphat

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

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India

Digital Content

RLD : No

TE Code : AB

PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2017-06-30

Application Number : 209177

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

Product Web Link

Digital Content

04

WATSON LABS

Ireland

Duphat

Not Confirmed

05

WATSON LABS

Ireland

Duphat

Not Confirmed

06

CHARTWELL RX

U.S.A

Duphat

Not Confirmed

07

HOSPIRA

U.S.A

Duphat

Not Confirmed

08

KVK TECH

U.S.A

Duphat

Not Confirmed

09

PHARM ASSOC

U.S.A

Duphat

Not Confirmed

10

WOCKHARDT BIO AG

India

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

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Europe

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Canada

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South Africa

01

Pharmacare Limited, Woodmead

South Africa

Duphat

Not Confirmed

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South Africa

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

promethazine HCl

Brand Name : Histodor

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 1000X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Pharmacare Limited, Woodmead

South Africa

Duphat

Not Confirmed

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South Africa

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Promethazine HCl

Brand Name : Stilpane

Dosage Form : SYR

Dosage Strength : 6.5mg/5ml

Packaging : 100X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Adcock Ingram Limited

South Africa

Duphat

Not Confirmed

04

Adcock Ingram Limited

South Africa

Duphat

Not Confirmed

05

Cipla Medpro (Pty) Ltd

South Africa

Duphat

Not Confirmed

06

Cipla Medpro (Pty) Ltd

South Africa

Duphat

Not Confirmed

07

Fresenius Kabi Manufacturing SA (Pty) Lt...

Germany

Duphat

Not Confirmed

08

iNova Pharmaceuticals (Pty) Ltd

Singapore

Duphat

Not Confirmed

09

iNova Pharmaceuticals (Pty) Ltd

Singapore

Duphat

Not Confirmed

10

iNova Pharmaceuticals (Pty) Ltd

Singapore

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

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Listed Dossiers

01

Strides Pharma Science

India

Duphat

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

Contact Supplier

India

Digital Content

Regulatory Info :

Registration Country : India

Promethazine Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

Product Web Link

Digital Content

02

Strides Pharma Science

India

Duphat

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

Contact Supplier

India

Digital Content

Regulatory Info :

Registration Country : India

Promethazine Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

Product Web Link

Digital Content

03

Strides Pharma Science

India

Duphat

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

Contact Supplier

India

Digital Content

Regulatory Info :

Registration Country : India

Promethazine Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

Product Web Link

Digital Content

04

Glumex Pharmaceuticals Mfg. Pvt. Ltd

India

Duphat

Not Confirmed

05

Ind Swift Laboratories Limited

India

Duphat

Not Confirmed

06

Lifespan Biotech

India

Duphat

Not Confirmed

07

Maxheal Pharmaceuticals (India) Ltd

India

Duphat

Not Confirmed

08

MS Pharma

Jordan

Duphat

Not Confirmed

09

MS Pharma

Jordan

Duphat

Not Confirmed

10

Umedica Laboratories Pvt Ltd

India

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

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DRUG PRODUCT COMPOSITIONS

Do you need Business Intel? Ask us

DOSAGE - INJECTABLE;INJECTION - 25MG/ML

USFDA APPLICATION NUMBER - 83312

DOSAGE - INJECTABLE;INJECTION - 50MG/ML

USFDA APPLICATION NUMBER - 83312

DOSAGE - SYRUP;ORAL - 6.25MG/5ML

USFDA APPLICATION NUMBER - 87953

DOSAGE - SYRUP;ORAL - 5MG/5ML;6.25MG/5ML

USFDA APPLICATION NUMBER - 88761

DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML

USFDA APPLICATION NUMBER - 88763

Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

Coating Systems & Additives

Thickeners and Stabilizers

Direct Compression

Controlled & Modified Release

01

Gangwal Healthcare

India

Duphat

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

Brand Name : DiCOM-DC® SR300

Application : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

Excipient Details : DiCOM-DC SR300 is used as a directly compressible, rate-controlling, and co-processed excipient in sustained-release tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : EthylCellulose

Gangwal Healthcare DiCOM-DC® SR300

Excipients Web Link

Digital Content

02

Gangwal Healthcare

India

Duphat

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Controlled & Modified Release

Brand Name : Gellets-P®

Application : Controlled & Modified Release

Excipient Details : Gellets-P are Microcrystalline Cellulose based spheres for the manufacturing of pellets and modified release products.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Microcrystalline Cellulose

Gangwal Healthcare Gellets-P®

Excipients Web Link

Digital Content

03

Kerry

U.S.A

Duphat

Not Confirmed

04

Aeon Procare

India

Duphat

Not Confirmed

05

Kerry

U.S.A

Duphat

Not Confirmed

06

Ideal Cures Pvt Ltd

India

Duphat

Not Confirmed

07

Ideal Cures Pvt Ltd

India

Duphat

Not Confirmed

08

Kerry

U.S.A

Duphat

Not Confirmed

09

Sigachi Industries

India

Duphat

Not Confirmed

10

The Dow Chemical Company

U.S.A

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

Solubilizers

01

DKSH

Switzerland

CPhI WW Frankfurt

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Solubilizers

Brand Name : HPC-SSL SFP

Application : Solubilizers

Excipient Details : HPC-SSL SFP is used as a binder and solubilizer in solid dosage forms including tablets, capsules, granules, and pellets.

Pharmacopoeia Ref : EP, JP, USP/NF, CEP, GMP, Hala...

Technical Specs : N/A

Ingredient(s) : Hydroxypropyl Cellulose

HPC-SSL SFP

Excipients Web Link

Digital Content

02

Nanjing Well Pharmaceutical

China

Duphat

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 80

Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

Polysorbate 80

Excipients Web Link

Digital Content

03

Valens Pharmachem

India

Duphat

Not Confirmed

04

Nanjing Bold Chemical

China

Duphat

Not Confirmed

05

The Dow Chemical Company

U.S.A

Duphat

Not Confirmed

06

BASF

Germany

Duphat

Not Confirmed

07

Seppic

France

Duphat

Not Confirmed

08

Actylis

U.S.A

Duphat

Not Confirmed

09

BASF

Germany

Duphat

Not Confirmed

10

Actylis

U.S.A

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

Film Formers & Plasticizers

Parenteral

Lubricants & Glidants

Co-Processed Excipients

Disintegrants & Superdisintegrants

Granulation

Taste Masking

Topical

01

DKSH

Switzerland

CPhI WW Frankfurt

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Cream / Lotion / Ointment, Suspension, Solution, Syrup

Grade : Topical, Oral

Category : Rheology Modifiers, Thickeners and Stabilizers, Topical

Brand Name : XANTURAL® 11000

Application : Rheology Modifiers, Thickeners and Stabilizers, Topical

Excipient Details : Xantural 11000 is used as a stabilizer and rheology modifier in oral dosage forms such as syrups, suspensions & solutions & in topical formulations.

Pharmacopoeia Ref : JP, EP, USP/NF

Technical Specs : N/A

Ingredient(s) : Xanthan Gum

XANTURAL® 11000

Excipients Web Link

Digital Content

02

Nanjing Well Pharmaceutical

China

Duphat

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 80

Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

Polysorbate 80

Excipients Web Link

Digital Content

03

Pluviaendo

Turkey

Duphat

Not Confirmed

04

DKSH

Switzerland

CPhI WW Frankfurt

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Cream / Lotion / Ointment, Suspension, Solution, Syrup

Grade : Topical, Oral

Category : Rheology Modifiers, Thickeners and Stabilizers, Topical

Brand Name : XANTURAL® 180

Application : Rheology Modifiers, Thickeners and Stabilizers, Topical

Excipient Details : Xantural 180 is used as a rheology modifier & stabilizer in oral dosage forms such as solutions, suspensions, and syrups & in topical formulations.

Pharmacopoeia Ref : JP, EP, USP/NF

Technical Specs : N/A

Ingredient(s) : Xanthan Gum

XANTURAL® 180

Excipients Web Link

Digital Content

05

Nanjing Well Pharmaceutical

China

Duphat

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels

Grade : Parenteral, Oral, Topical

Category : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

Brand Name : Propylene Glycol

Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Propylene Glycol

Nanjing Well Propylene Glycol

Excipients Web Link

Digital Content

06

Finar

India

Duphat

Not Confirmed

07

Valens Pharmachem

India

Duphat

Not Confirmed

08

Nanjing Bold Chemical

China

Duphat

Not Confirmed

09

Seppic

France

Duphat

Not Confirmed

10

BASF

Germany

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

Empty Capsules

Emulsifying Agents

API Stability Enhancers

Rheology Modifiers

Chewable & Orodispersible Aids

Coloring Agents

Vegetarian Capsules

Surfactant & Foaming Agents

Soft Gelatin

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Finished Drug Prices

01

Brand Name : PROMETHAZINE HYDROCHLORIDE

United Kingdom

Duphat

Not Confirmed

02

Brand Name : PROMETHAZINE HYDROCHLORIDE

United Kingdom

Duphat

Not Confirmed

03

Brand Name : PROMETHAZINE HYDROCHLORIDE

U.S.A

Duphat

Not Confirmed

04

Brand Name : PROMETHAZINE HYDROCHLORIDE

U.S.A

Duphat

Not Confirmed

05

Brand Name : PROMETHEGAN

U.S.A

Duphat

Not Confirmed

06

Brand Name : PROMETHAZINE HYDROCHLORIDE

Israel

Duphat

Not Confirmed

07

Brand Name : PROMETHAZINE HYDROCHLORIDE

Israel

Duphat

Not Confirmed

08

Brand Name : PROMETHAZINE HYDROCHLORIDE

Ireland

Duphat

Not Confirmed

09

Brand Name : PROMETHAZINE HYDROCHLORIDE

Ireland

Duphat

Not Confirmed

10

Brand Name : PROMETHAZINE HYDROCHLORIDE

U.S.A

Duphat

Not Confirmed

Only 10 entries up to this point, click to access all

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APIs

Promethazine Hydrochloride API needed in India [ENA19547]

A company that focuses on the distribution of a wide spectrum of functional and reliable raw materials across various sectors, including pharmaceuticals, nutraceuticals, food, ink, paint, and more is looking for suppliers of Promethazine Hydrochloride API for commercial purposes. The suppliers must support this enquiry with CoA.

Reply

21 May 2024

IP Grade Promethazine HCl (750 g) API needed in India [ENA18525]

A company that focuses on the development & manufacturing of syrups, suspensions & drops is looking for suppliers of IP Grade Promethazine HCl (750 g) API for development purposes. The suppliers must support this enquiry with CoA.

Reply

02 Nov 2023

Promethazine HCl (500 kg) API needed in India [ENA18102]

A company that deals in various pharmaceutical products is looking for suppliers of Promethazine HCl (500 kg) API for commercial purposes. The suppliers must support this enquiry with CEP & CoA.

Reply

20 Sep 2023

Promethazine HCl (150 kg - 200 kg/ annum) API needed in the United States [ENA17811]

A pharmaceutical company that focuses on the development & manufacturing of generic finished formulations is looking for suppliers of Micronized Promethazine HCl (150 kg - 200 kg/ annum) API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.

Reply

15 Aug 2023

Various APIs needed in Bahrain [ENA17650]

A contract manufacturing organization that focuses on the development & manufacturing of parenteral formulations is looking for suppliers of Various APIs for initially development & later commercial purposes. The suppliers must support this enquiry with CEP and CoA. 1. EP Grade Acetylcysteine (42 kg) API 2. EP Grade Amiodarone HCl (10.5 kg) API 3. EP Grade Atropine Sulfate Monohydrate (84 g) API 4. EP Grade Biperiden Lactate (1.05 kg) API 5. EP Grade Dexamethasone Sodium Phosphate (924 g) API 6. EP Grade Diphenhydramine HCl (10.5 kg) API 7. EP Grade Hyoscine Butylbromide (4.2 kg) API 8. EP Grade Iron Sucrose (42 kg) API 9. Micronized & EP Grade Ketoprofen (10.5 kg) API 10. EP Grade Phenylephrine HCl (2.1 kg) API 11. EP Grade Phytonadione (2.1 kg) API 12. EP Grade Promethazine HCl (5.25 kg) API 13. EP Grade Ranitidine HCl (5.88 kg) API

Reply

24 Jul 2023

Various APIs needed in Turkey [ENA17241]

A pharmaceutical company that focuses on the development and marketing of various finished formulations such as tablets, capsules, injections, and infusions is looking for suppliers of Various APIs for development purposes. The suppliers must support this enquiry with CEP or DMF, GMP & CoA. 1. Dantrolene Sodium API 2. Clocortolone Pivalate API 3. Darifenacin Hydrobromide API 4. Nitrofurantoin API 5. Cyclobenzaprine HCl API 6. Ivermectin API 7. Clomiphene Citrate API 8. Mirabegron API 9. Diltiazem API 10. Metaxalone API 11. Promethazine HCl API

Reply

06 Jun 2023

Various APIs needed in Bahrain [ENA15399]

A contract manufacturing organization that specializes in the manufacturing of parenteral formulations is looking for suppliers of Various APIs for development purpose. The suppliers must support this enquiry with CEP (optional), GMP & CoA. 1. USP/ Injectable Grade Promethazine HCl (100 g) API 2. USP/ Injectable Grade Ranitidine HCl (100 g) API 3. USP/ Injectable Grade Rocuronium Bromide (15 g) API 4. Ph. Eur./ Injectable Grade Sodium Hyaluronate (45 g) API 5. Ph. Eur./ Injectable Grade Sodium Valproate API

Reply

24 Oct 2022

Promethazine HCl API needed in India [ENA13131]

A company that specializes in manufacturing a wide range of pharmaceutical products in general category is looking for suppliers of Promethazine HCl API for commercial purpose. The suppliers must support this enquiry with CoA.

Reply

29 Mar 2022

BP & Injectable Grade Promethazine Hydrochloride (MOQ) API needed in India [ENA12992]

A company that deals in distribution of various pharmaceutical products is looking for suppliers of BP & Injectable Grade Promethazine Hydrochloride (MOQ) API for commercial purpose. The suppliers must support this enquiry with CoA.

Reply

14 Mar 2022

Various APIs needed in Bangladesh [ENA11253]

A company that provides world-class solutions to the local pharmaceutical industry is looking for suppliers of Various APIs for one of their client. 1. BP Grade Promethazine HCl API 2. BP Grade Sitagliptin Phosphate Monohydrate API 3. BP Grade Simvastatin API 4. Ertugliflozin L-pyroglutamic Acid API 5. USP Grade Zileuton API 6. Ibrexafungerp Citrate API 7. Sterile Meropenem & Vaborbactam API 8. USP Grade Phenylephrine HCl API

Reply

31 Aug 2021

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FDF DOSSIERS

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REF. STANDARDS & IMPURITIES

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EDQM

01

EDQM, Council of Europe

Promethazine for peak identification

Duphat

Not Confirmed

02

EDQM, Council of Europe

Promethazine impurity D

Duphat

Not Confirmed

03

EDQM, Council of Europe

Promethazine hydrochloride

Duphat

Not Confirmed

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USP

01

USP

U.S.A

Duphat

Not Confirmed

Others

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ABOUT THIS PAGE

Promethazine Hydrochloride Manufacturers

A Promethazine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Promethazine Hydrochloride, including repackagers and relabelers. The FDA regulates Promethazine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Promethazine Hydrochloride 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 Promethazine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Promethazine Hydrochloride Suppliers

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

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

Promethazine Hydrochloride USDMF

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

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

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

Promethazine Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Promethazine Hydrochloride Drug Master File in Japan (Promethazine Hydrochloride JDMF) empowers Promethazine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Promethazine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Promethazine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Promethazine Hydrochloride suppliers with JDMF on PharmaCompass.

Promethazine Hydrochloride CEP

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

A Promethazine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Promethazine Hydrochloride 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 Promethazine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Promethazine Hydrochloride WC

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

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

Promethazine Hydrochloride 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 Promethazine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Promethazine Hydrochloride 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 Promethazine Hydrochloride 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 Promethazine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Promethazine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

Promethazine Hydrochloride GMP

Promethazine Hydrochloride 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 Promethazine Hydrochloride 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 Promethazine Hydrochloride GMP manufacturer or Promethazine Hydrochloride GMP API supplier for your needs.

Promethazine Hydrochloride CoA

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

Promethazine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Promethazine Hydrochloride 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.

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