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55 API Suppliers, 16 USDMF, 13 CEP/COS, 23 EU WC, 3 KDMF, 11 NDC API, 36 Listed Suppliers, $ API Reference Price

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23 EU WC
3 KDMF
11 NDC API
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24 FDA Orange Book
153 Europe
5 Canada
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54 Listed Dossiers

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TABLET;ORAL - 5MG, SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

drugProductComposition
TABLET;ORAL - 5MG
SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

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4 Nanjing Well Pharmaceutical
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1 Alcedo Pharmachem
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28 BASF
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1 Doshion Polyscience
2 Finar
11 Gangwal Chemicals
7 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
39 Kerry
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6 Lonza Capsugel
16 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
3 Novo Excipients
4 Pharmatrans-Sanaq
7 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
29 Roquette
13 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
2 The Dow Chemical Company
2 Valens Pharmachem
4 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

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Synopsis

ACTIVE PHARMA INGREDIENTS

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Listed Suppliers

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$ 912

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FDF

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277

FDF Dossiers

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153

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Canada

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South Africa

Listed Dossiers

3DRUGS IN DEVELOPMENT

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EDQM

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534EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 100643-71-8, Clarinex, Descarboethoxyloratadine, Desloratidine, Neoclarityn, Aerius

Molecular Formula

C₁₉H₁₉ClN₂

Molecular Weight

310.8 g/mol

InChI Key

JAUOIFJMECXRGI-UHFFFAOYSA-N

FDA UNII

FVF865388R

Desloratadine is a long-acting piperidine derivate with selective H1 antihistaminergic and non-sedating properties. Desloratadine diminishes the typical histaminergic effects on H1-receptors in bronchial smooth muscle, capillaries and gastrointestinal smooth muscle, including vasodilation, bronchoconstriction, increased vascular permeability, pain, itching and spasmodic contractions of gastrointestinal smooth muscle. Desloratadine is used to provide symptomatic relieve of allergic symptoms.

Desloratadine is a Histamine-1 Receptor Antagonist. The mechanism of action of desloratadine is as a Histamine H1 Receptor Antagonist.

1 2D Structure

Desloratadine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

13-chloro-2-piperidin-4-ylidene-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene

2.1.2 InChI

InChI=1S/C19H19ClN2/c20-16-5-6-17-15(12-16)4-3-14-2-1-9-22-19(14)18(17)13-7-10-21-11-8-13/h1-2,5-6,9,12,21H,3-4,7-8,10-11H2

2.1.3 InChI Key

JAUOIFJMECXRGI-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CC2=C(C=CC(=C2)Cl)C(=C3CCNCC3)C4=C1C=CC=N4

2.2 Other Identifiers

2.2.1 UNII

FVF865388R

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Aerius

2. Clarinex

3. Descarboethoxyloratadine

4. Descarboethoxyloratadine Acetate

5. Neoclarityn

6. Sch 34117

7. Sch-34117

2.3.2 Depositor-Supplied Synonyms

1. 100643-71-8

2. Clarinex

3. Descarboethoxyloratadine

4. Desloratidine

5. Neoclarityn

6. Aerius

7. Azomyr

8. Sch-34117

9. Denosin

10. Allex

11. Opulis

12. Sch 34117

13. 8-chloro-11-piperidin-4-ylidene-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

14. Descarboethoxyoratidine

15. Desloratadine Actavis

16. Dasselta

17. Desloratadine Teva

18. Mfcd00871949

19. 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

20. Nsc-759824

21. Chembl1172

22. Loratadine Related Compound A

23. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2-b)pyridine

24. Mls000559042

25. Chebi:291342

26. Fvf865388r

27. Nsc675447

28. 5h-benzo[5,6]cyclohepta[1,2-b]pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-

29. 13-chloro-2-piperidin-4-ylidene-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene

30. Ncgc00159325-02

31. Smr000149358

32. Desloratadine [usan]

33. Clarinex Reditabs

34. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

35. Dsstox_cid_24196

36. Dsstox_rid_80112

37. Dsstox_gsid_44196

38. Desalex

39. 5h-benzo(5,6)cyclohepta(1,2-b)pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-

40. 8-chloro-11-piperidin-4-ylidene-5,6-dihydrobenzo[1,2]cyclohepta[2,4-b]pyridine

41. 8-chloro-6,11-dihydro-11-(4-piperdinylidene)- 5h-benzo[5,6]cyclohepta[1,2-b]pyridine

42. Clarinex (tn)

43. 13-chloro-2-(piperidin-4-ylidene)-4-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaene

44. 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine (descarboethoxyloratadine; Desloratadine)

45. Cas-100643-71-8

46. Sr-01000668962

47. Unii-fvf865388r

48. Desloratadine [usan:inn:ban]

49. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine

50. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine

51. 4-{8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}-piperidine

52. 4-{8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}piperidine

53. Desloratadine-[d7]

54. Desloratadine- Bio-x

55. Mk-4117

56. Cpd000149358

57. Opera_id_1891

58. Desloratadine [mi]

59. Desloratadine [inn]

60. Desloratadine [jan]

61. Schembl4425

62. Desloratadine [vandf]

63. Mls000759406

64. Mls001201801

65. Mls001424247

66. Desloratadine [mart.]

67. Sch34117

68. Desloratadine Ratiopharm

69. Desloratadine [usp-rs]

70. Desloratadine [who-dd]

71. Desloratadine (jan/usp/inn)

72. Gtpl7157

73. Zinc1261

74. Desloratadine [ema Epar]

75. Dtxsid1044196

76. Loratadine Related Compound A Rs

77. Hms2052h05

78. Hms2090c06

79. Hms2093f19

80. Hms3394h05

81. Hms3652o15

82. Hms3715j15

83. Hms3885c18

84. Pharmakon1600-01505393

85. Desloratadine [orange Book]

86. Albb-027276

87. Bcp02340

88. Desloratadine For System Suitability

89. Hy-b0539

90. Desloratadine [ep Monograph]

91. Tox21_111574

92. Bbl010777

93. Bdbm50073179

94. Desloratadine [usp Monograph]

95. Nsc759824

96. S4012

97. Stk586537

98. Akos000280921

99. Tox21_111574_1

100. Ac-1279

101. Ccg-101162

102. Db00967

103. Ks-1048

104. Nc00412

105. Nsc 675447

106. Nsc 759824

107. Nsc-675447

108. Sb17503

109. Clarinex-d Component Desloratadine

110. Desloratadine 100 Microg/ml In Methanol

111. Desloratadine, Powder, >=98% (hplc)

112. Ncgc00159325-03

113. Ncgc00159325-04

114. Ncgc00159325-05

115. Bd164361

116. Loratadine Ep Impurity D (desloratadine)

117. Sbi-0206828.p001

118. Loratadine Impurity D [ep Impurity]

119. D3787

120. Desloratadine Component Of Clarinex-d

121. Ft-0602522

122. Ft-0666048

123. Sw197792-3

124. A19515

125. D03693

126. H11943

127. Loratadine Related Compound A [usp-rs]

128. Ab00456701-11

129. Ab00456701-13

130. Ab00456701_14

131. Ab00456701_15

132. 643d718

133. L001025

134. Q418060

135. Loratadine Related Compound A [usp Impurity]

136. Q-200936

137. Rupatadine Fumarate Impurity B [ep Impurity]

138. Sr-01000668962-4

139. Sr-01000668962-5

140. Sr-01000668962-8

141. Brd-k82357231-001-13-4

142. Desloratadine Teva (authorized: Rhinitis, Urticaria)

143. Desloratadine Actavis (authorized: Rhinitis, Urticaria)

144. Desloratadine, European Pharmacopoeia (ep) Reference Standard

145. Desloratadine Ratiopharm (authorized: Rhinitis, Urticaria)

146. Desloratadine, United States Pharmacopeia (usp) Reference Standard

147. 4-(8-chloro-5,6-dihydro-11 H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine

148. 4-(8-chloro-5,6-dihydro-11h-benzo-[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine

149. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta [1,2-b]pyridin-11-ylidene) Piperidine

150. 4-(8-chloro-5,6-dihydro-11h-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene) Piperidine

151. 8-chloro-11-(4-piperidinylidene)-6,11-dihydro-5h- Benzo[4,5]cyclohepta[2,1-b]pyridine

152. 8-chloro-11-(4-piperidyliden)-6,11-dihydro-5h-benzo[5,6]cyclohepta [1,2-b]pyridine

153. 8-chloro-11-(4-piperidyliden)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

154. 8-chloro-11-(4-piperidylidene)-6,11-dihydro-5h-benzo[5.6]cyclohepta[1,2-b]pyridine

155. 8-chloro-6,11-dihydro-11-(4-piperidylidene)-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

156. Desloratadine For System Suitability, European Pharmacopoeia (ep) Reference Standard

157. Desloratidine, Pharmaceutical Secondary Standard; Certified Reference Material

158. Loratadine Related Compound A, United States Pharmacopeia (usp) Reference Standard

159. 13-chloro-2-(piperidin-4-ylidene)-4-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3,5,7,12,14-hexaene

160. 8-chloro-11-(4-piperidylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

161. 8-chloro-6,11-dihydro-11(4-piperidylidene)-5h-benzo(5,6)cyclohepta(1,2-b) Pyridine

162. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2-bpyridine

163. 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5h-benzo(5,6)cyclohepta(1,2b)pyridine

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₁₉ClN₂
Molecular Weight	310.8 g/mol
XLogP3	4.5
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	0
Exact Mass	310.1236763 g/mol
Monoisotopic Mass	310.1236763 g/mol
Topological Polar Surface Area	24.9 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	425
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Clarinex
PubMed Health	Desloratadine (By mouth)
Drug Classes	Respiratory Agent
Drug Label	CLARINEX (desloratadine) Tablets are light blue, round, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. CLARINEX Tablets also contain the following excipients: dibasic calcium phosphate dihydrate USP, m...
Active Ingredient	Desloratadine
Dosage Form	Tablet, orally disintegrating; Tablet; Syrup; Solution
Route	oral; Oral
Strength	2.5mg; 5mg; 0.5mg/ml
Market Status	Prescription
Company	Merck Sharp Dohme; Schering

2 of 4
Drug Name	Desloratadine
PubMed Health	Desloratadine (By mouth)
Drug Classes	Respiratory Agent
Drug Label	Desloratadine tablets are blue, round, film-coated tablets debossed with logo L5 on one side containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine tablets also contain the following excipients: carnauba wax,...
Active Ingredient	Desloratadine
Dosage Form	Tablet, orally disintegrating; Tablet
Route	oral; Oral
Strength	2.5mg; 5mg
Market Status	Tentative Approval; Prescription
Company	Perrigo R And D; Mylan Pharms; Glenmark Generics; Belcher Pharms; Lupin Pharms; Sun Pharm Inds; Reddys; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare

3 of 4
Drug Name	Clarinex
PubMed Health	Desloratadine (By mouth)
Drug Classes	Respiratory Agent
Drug Label	CLARINEX (desloratadine) Tablets are light blue, round, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. CLARINEX Tablets also contain the following excipients: dibasic calcium phosphate dihydrate USP, m...
Active Ingredient	Desloratadine
Dosage Form	Tablet, orally disintegrating; Tablet; Syrup; Solution
Route	oral; Oral
Strength	2.5mg; 5mg; 0.5mg/ml
Market Status	Prescription
Company	Merck Sharp Dohme; Schering

4 of 4
Drug Name	Desloratadine
PubMed Health	Desloratadine (By mouth)
Drug Classes	Respiratory Agent
Drug Label	Desloratadine tablets are blue, round, film-coated tablets debossed with logo L5 on one side containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine tablets also contain the following excipients: carnauba wax,...
Active Ingredient	Desloratadine
Dosage Form	Tablet, orally disintegrating; Tablet
Route	oral; Oral
Strength	2.5mg; 5mg
Market Status	Tentative Approval; Prescription
Company	Perrigo R And D; Mylan Pharms; Glenmark Generics; Belcher Pharms; Lupin Pharms; Sun Pharm Inds; Reddys; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare

4.2 Drug Indication

For the relief of symptoms of seasonal allergic rhinitis, perennial (non-seasonal) allergic rhinitis. Desloratidine is also used for the sympomatic treatment of pruritus and urticaria (hives) associated with chronic idiopathic urticaria.

FDA Label

Azomyr is indicated for the relief of symptoms associated with:

- allergic rhinitis (see section 5. 1)

- urticaria (see section 5. 1)

Aerius is indicated for the relief of symptoms associated with:

- allergic rhinitis;

- urticaria.

Neoclarityn is indicated for the relief of symptoms associated with:

- allergic rhinitis

- urticaria

Treatment of allergic rhinitis and urticaria.

Desloratadine Teva is indicated for the relief of symptoms associated with:

- allergic rhinitis;

- urticaria.

Dasselta is indicated for the relief of symptoms associated with:

- allergic rhinitis;

- urticaria.

Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:

- allergic rhinitis

- chronic idiopathic urticaria as initially diagnosed by a physician

Aerius is indicated for the relief of symptoms associated with:

- allergic rhinitis (see section 5. 1)

- urticaria (see section 5. 1)

Opulis is indicated for the relief of symptoms associated with:

- allergic rhinitis (see section 5. 1)

- urticaria (see section 5. 1)

5 Pharmacology and Biochemistry

5.1 Pharmacology

Desloratadine is a long-acting second-generation H₁-receptor antagonist which has a selective and peripheral H1-antagonist action. Histamine is a chemical that causes many of the signs that are part of allergic reactions, such as the swelling of tissues. Histamine is released from histamine-storing cells (mast cells) and attaches to other cells that have receptors for histamine. The attachment of the histamine to the receptors causes the cell to be "activated," releasing other chemicals which produce the effects that we associate with allergies. Desloratadine blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of cells by histamine. Unlike most other antihistamines, Desloratadine does not enter the brain from the blood and, therefore, does not cause drowsiness.

5.2 MeSH Pharmacological Classification

Cholinergic Antagonists

Drugs that bind to but do not activate CHOLINERGIC RECEPTORS, thereby blocking the actions of ACETYLCHOLINE or cholinergic agonists. (See all compounds classified as Cholinergic Antagonists.)

Histamine H1 Antagonists, Non-Sedating

A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

DESLORATADINE

5.3.2 FDA UNII

FVF865388R

5.3.3 Pharmacological Classes

Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]

5.4 ATC Code

R06AX27

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

R - Respiratory system

R06 - Antihistamines for systemic use

R06A - Antihistamines for systemic use

R06AX - Other antihistamines for systemic use

R06AX27 - Desloratadine

5.5 Absorption, Distribution and Excretion

Absorption

Desloratadine administered orally for ten days to healthy volunteers as a 5 mg tablet once daily resulted in a mean T_max of approximately 3 hours, a mean steady-state C_max of 4 ng/ml, and a mean steady-state AUC of 56.9 ng\*hr/ml. A similar profile was observed using 10 ml of an oral solution containing 5 mg of desloratadine. Food was found not to affect desloratadine absorption.

Route of Elimination

Approximately 87% of a ¹⁴C-desloratadine dose was equally recovered in urine and feces as metabolic products.

5.6 Metabolism/Metabolites

Desloratadine is metabolized to the active metabolite 3-hydroxydesloratadine, which is subsequently glucuronidated.

Desloratadine is a known human metabolite of Rupatadine and loratadine.

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

5.7 Biological Half-Life

Desloratadine has a mean plasma elimination half-life of approximately 27 hours.

5.8 Mechanism of Action

Like other H1-blockers, Desloratadine competes with free histamine for binding at H₁-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine.

API SUPPLIERS

01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

DKSH

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

Booth #8.0P66

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

Contact Supplier

Switzerland

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF Others AUDIT

04

Jai Radhe Sales

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

05

Aptra Synthesis

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof

Not Confirmed

Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

06

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU, MX, ...

AUDIT

07

Octavius Pharma Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

08

Shandong Loncom Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Contact Supplier

China

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Shandong Loncom Pharmaceutical company banner

09

Tagoor Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC

NDC KDMF VMF Others AUDIT

10

Atman Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Cosmoprof

Not Confirmed

Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

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USDMF

01

Dr Reddys Laboratories Ltd

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

DESLORATADINE USP

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19456

Submission : 2006-05-24

Status : Active

Type : II

02

Teva Pharmaceutical Industries Ltd

Israel

World ADC London

Attending

TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

Contact Supplier

Israel

Virtual Booth

Digital Content

DESLORATADINE DRUG SUBSTANCE

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19403

Submission : 2006-05-02

Status : Inactive

Type : II

03

Cadila Pharmaceuticals Ltd

India

Cosmoprof

Not Confirmed

04

Cipla Ltd

India

India

Cosmoprof

Not Confirmed

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

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CEP/COS

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EU WC

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

Desloratadine USP/EP/IH

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0067

Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...

02

Tagoor Laboratories

India

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

Contact Supplier

India

Virtual Booth

Digital Content

Desloratadine EP/BP/USP

Date of Issue : 2024-12-09

Valid Till : 2027-02-26

Written Confirmation Number : WC-0494

Address of the Firm : Unit-1, Sy. No.29, Tupakulagudem (Village), Pochavaram Panchayat, Tallapudi (Man...

03

Abhilasha Pharma

India

Cosmoprof

Not Confirmed

04

Amsal Chem Private Ltd.

India

Cosmoprof

Not Confirmed

05

Divis Laboratories

India

Cosmoprof

Not Confirmed

06

Enaltec Labs Private Limited

India

India

Cosmoprof

Not Confirmed

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KDMF

01

Merck & Co

U.S.A

Cosmoprof

Not Confirmed

02

Merck & Co

U.S.A

Cosmoprof

Not Confirmed

03

Viatris

U.S.A

Cosmoprof

Not Confirmed

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NDC API

01

Dr.Reddy's Laboratories Limited

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

DESLORATADINE

NDC Package Code : 55111-073

Start Marketing Date : 2006-05-24

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Portfolio PDF

Product Web Link

Virtual Booth

Vasudha Pharma Chem Limited

India

Cosmoprof

Not Confirmed

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Listed Suppliers

01

LGM Pharma

U.S.A

Cosmoprof

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Desloratadine

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

02

DKSH

Switzerland

CPhI WW Frankfurt

Booth #8.0P66

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

Contact Supplier

Switzerland

Virtual Booth

Digital Content

Desloratadine

About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...

DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering growth for businesses in Asia and beyond for over 155 years. DKSH operates in 36 markets, is listed on the SIX Swiss Exchange, employs 33,100 specialists, and generated net sales of CHF 11.1 billion in 2021. It is the leading global distributor of innovative pharma ingredients for pharmaceutical synthesis and formulation. It offers a range of products, ranging from animal care products to packaging materials, intermediates to nutraceuticals, and APIs to excipients.

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

Desloratadine

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale

04

Jai Radhe Sales

India

Cosmoprof

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

India

Virtual Booth

Digital Content

Desloratadine

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.

05

Aptra Synthesis

India

Cosmoprof

Not Confirmed

Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

Contact Supplier

India

Virtual Booth

Digital Content

Desloratadine

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.

06

HRV Global Life Sciences

India

Cosmoprof

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

Desloratadine

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

07

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Contact Supplier

India

Virtual Booth

Digital Content

Desloratadine

About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...

Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a wide range of products such as tablets, capsules, syrups and ointments. Its portfolio includes finished dosage formulations, herbal/food supplements and APIs. It exports bulk drugs, finished formulations and APIs, while maintaining quality in compliance with WHO GMP norms. With an experienced team, Octavius Pharma provides consulting services for formulation development and marketing. Octavius exports to LATAM, Middle East, African, Asian and CIS countries.

08

Shandong Loncom Pharmaceutical

China

Cosmoprof

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Contact Supplier

China

Virtual Booth

Digital Content

Desloratadine

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.

09

Tagoor Laboratories

India

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

Contact Supplier

India

Virtual Booth

Digital Content

Desloratadine

About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...

Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-growth therapeutic areas, with an emphasis on affordability, quality and timely delivery. It also provides end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs is a fast-growing Indian pharma company that serves both branded and generic companies worldwide. The company’s organizational function includes R&D, supply chain, manufacturing, quality testing, quality assurance, regulatory affairs, marketing & sales, and packaging & warehousing departments.

10

Atman Pharmaceuticals

India

Cosmoprof

Not Confirmed

Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.

Contact Supplier

India

Virtual Booth

Digital Content

Desloratadine

About the Company : Atman Pharmaceuticals is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and overseas. ...

Atman Pharmaceuticals is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and overseas. With a heritage spanning over 33 years and vast experience, we have earned a reputation for delivering high-quality and abundant services within the industry. Our emergence as prominent solution providers in the pharmaceutical business underscores our commitment to excellence.

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API Reference Price

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","customerCountry":"PAKISTAN","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"440","totalValueFC":"8490.9","currency":"USD","unitRateINR":31050,"date":"27-Jan-2021","totalValueINR":"621000","totalValueInUsd":"8490.9","indian_port":"DELHI AIR","hs_no":"29420090","bill_no":"8171745","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"MOREPEN VILLAGE, NALAGARH ROAD,NEAR BADDI,, DISTT.SOLAN (HP)","customerAddress":""},{"dataSource":"API Export","activeIngredients":"DESLORATADINE","year":"2021","qtr":"Q1","strtotime":1611945000,"product":"DESLORATADINE EP BATCH NO.:20DD023","address":"CADILA CORPORATE CAMPUSSARKHEJ DHOLKA ROAD, BHAT","city":"AHMEDABAD, GUJARAT","supplier":"CADILA PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"BELAGA","customer":"GALENIKA A.D.","customerCountry":"SERBIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1469.4","totalValueFC":"1487.7","currency":"USD","unitRateINR":108809.23,"date":"30-Jan-2021","totalValueINR":"108809.23","totalValueInUsd":"1487.7","indian_port":"AHMEDABAD AIR","hs_no":"29333990","bill_no":"8266621","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SERBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"CADILA CORPORATE CAMPUSSARKHEJ DHOLKA ROAD, BHAT, AHMEDABAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"DESLORATADINE","year":"2021","qtr":"Q1","strtotime":1611945000,"product":"DESLORATADINE BP\/PH.EUR. 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NO: DESFC5_04032019 (FOR RESEARCH AND TESTING PURPOSES ONLY)","address":"210 - 210A, GALLERIA, HIRANANDANI GARDENS, POWAI,","city":"MUMBAI, MAHARASHTRA","supplier":"SPECIFAR S.A","supplierCountry":"GREECE","foreign_port":"ATHENS","customer":"ACTAVIS INC","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"0.3","totalValueFC":"31.8","currency":"EUR","unitRateINR":"46.7","date":"28-Jun-2021","totalValueINR":"2335.88","totalValueInUsd":"31.8","indian_port":"MADRAS AIR","hs_no":"29319090","bill_no":"4479200","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"ATHENS","supplierAddress":"","customerAddress":"210 - 210A, GALLERIA, HIRANANDANI GARDENS, POWAI,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1633717800,"product":"DESLORATADINE (DLP) MI IH(DESLORATADINE F-I (DLP) MI PH.EUR)(S.B NO:1215001 DATE:19.04.2021)COMMERCIAL USE ONLY (P.O.NO:","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"19.92","actualQuantity":"19.92","unit":"KGS","unitRateFc":"940","totalValueFC":"18921.8","currency":"USD","unitRateINR":"71158","date":"09-Oct-2021","totalValueINR":"1417467.36","totalValueInUsd":"18921.8","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"5784451","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655058600,"product":"DESLORATADINE (DLP) MI IH","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"VIATRIS","supplierCountry":"IRELAND","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"1.95","actualQuantity":"1.946","unit":"KGS","unitRateFc":"940","totalValueFC":"1840.6","currency":"USD","unitRateINR":"73790","date":"13-Jun-2022","totalValueINR":"143595.34","totalValueInUsd":"1840.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9089284","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662921000,"product":"DESLORATADINE PH.EUR, BATCH NO. TDDLTNF005, TDDLTNF006,TDDLTNF007,(RE-IMPORT AFTER REJECTED VIDE S.B. NO. 8682272 DT 4-3","address":"SPARC TANDALJA","city":"VADODARA","supplier":"GENEPHARM S.A","supplierCountry":"INDIA","foreign_port":"NA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"99.95","actualQuantity":"99.946","unit":"KGS","unitRateFc":"995","totalValueFC":"101150.3","currency":"USD","unitRateINR":"81106.7","date":"12-Sep-2022","totalValueINR":"8106287.51","totalValueInUsd":"101150.3","indian_port":"DELHI AIR","hs_no":"29420090","bill_no":"2402892","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SPARC TANDALJA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671474600,"product":"DESLORATADINE- \\'DESLORATADINE (DLP) MI IH ( FOR COMMERCIAL USE ONLY)","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"19.92","actualQuantity":"19.92","unit":"KGS","unitRateFc":"1068","totalValueFC":"21569.8","currency":"USD","unitRateINR":"89231.4","date":"20-Dec-2022","totalValueINR":"1777489.49","totalValueInUsd":"21569.8","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"3833383","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"DESLORATADINE(QTY:1 X 1 G, VALUE: USD 42.69) (FOC) SAMPLES FOR IN HOUSE R&D\/TESTING PURPOSE","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.001","unit":"KGS","unitRateFc":"44836","totalValueFC":"45","currency":"USD","unitRateINR":"3826760","date":"05-Dec-2024","totalValueINR":"3826.76","totalValueInUsd":"45","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7065348","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK, MD, US 21704, UNITED STATES OF AMER ICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"DESLORATADINE(QTY:3 X 0.2 G, VALUE: USD 19.77\/EACH) (FOC) SAMPLES FOR IN HOUSE R&D\/TESTING PURPOSE","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0006","unit":"KGS","unitRateFc":"103820","totalValueFC":"62.6","currency":"USD","unitRateINR":"8860983.3","date":"05-Dec-2024","totalValueINR":"5316.59","totalValueInUsd":"62.6","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7065348","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK, MD, US 21704, UNITED STATES OF AMER ICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]

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 F. Hoffmann-La Roche

Switzerland

BIO Partnering at JPM

Not Confirmed

02 F. Hoffmann-La Roche

Switzerland

BIO Partnering at JPM

Not Confirmed

03 F. Hoffmann-La Roche

Switzerland

BIO Partnering at JPM

Not Confirmed

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INTERMEDIATES SUPPLIERS

01

Vamsi Labs

India

DCAT Week

Attending

Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

N-Methyl-4- Chloro Piperidine

CAS Number : 5570-77-4

End Use API : Desloratadine

02

Tagoor Laboratories

India

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

2-Cyano-3-[2(3-chloro phenyl) ethyl]pyridine (L-5)

CAS Number : 31255-57-9

End Use API : Desloratadine

03

Tagoor Laboratories

India

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

N-Methyl-4-chloropiperidine

CAS Number : 5570-77-4

End Use API : Desloratadine

04

Tagoor Laboratories

India

CPhI China

Booth #E1Q18

Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylid...

CAS Number : 38092-89-6

End Use API : Desloratadine

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Virtual Booth

India

BIO Partnering at JPM

Not Confirmed

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Listed Dossiers

01

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

PharmaVenue

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Contact Supplier

Germany

Virtual Booth

Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

Desloratadine

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

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Virtual Booth

Digital Content

Website

Corporate PDF

02

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Desloratadine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

03

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : DMF Available|FDF Compliance-U...

Registration Country : India

Desloratadine

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-U...

Registration Country : India

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U.A.E

PharmaVenue

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 21165

DOSAGE - SOLUTION;ORAL - 0.5MG/ML **Federal R...DOSAGE - SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21300

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

USFDA APPLICATION NUMBER - 21313

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ABOUT THIS PAGE

Desloratadine Manufacturers

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

Desloratadine Suppliers

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

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

Desloratadine USDMF

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

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

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

Desloratadine KDMF

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

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

After submitting a Desloratadine 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 Desloratadine API can apply through the Korea Drug Master File (KDMF).

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

Desloratadine CEP

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

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

Desloratadine WC

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

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

Desloratadine 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 Desloratadine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Desloratadine GMP

Desloratadine 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 Desloratadine 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 Desloratadine GMP manufacturer or Desloratadine GMP API supplier for your needs.

Desloratadine CoA

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

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

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

55 API Suppliers

16 USDMF

13 CEP/COS

23 EU WC

3 KDMF

11 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

277 FDF Dossiers

24 FDA Orange Book

153 Europe

5 Canada

41 South Africa

54 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG

SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

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EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders

60 Coating Systems & Additives

SOLUTION;ORAL - 0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons