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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 10 USDMF, 5 CEP/COS, 2 JDMF, 5 EU WC, 1 KDMF, 10 NDC API, 16 Listed Suppliers, $ API Reference Price

26 API Suppliers
10 USDMF
5 CEP/COS
2 JDMF
5 EU WC
1 KDMF
10 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

132 FDF Dossiers, 66 FDA Orange Book, 33 Europe, 8 Canada, 4 Australia, 8 South Africa, 13 Listed Dossiers

132 FDF Dossiers
66 FDA Orange Book
33 Europe
8 Canada
4 Australia
8 South Africa
13 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 50MG, CAPSULE;ORAL - 75MG

drugProductComposition
CAPSULE;ORAL - 25MG
CAPSULE;ORAL - 50MG
CAPSULE;ORAL - 75MG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 8 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 2 DFE Pharma, 1 Finar, 3 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 15 Kerry, 3 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 8 Roquette, 2 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders, 21 Direct Compression, 13 Granulation, 12 Lubricants & Glidants, 10 Co-Processed Excipients, 10 Coating Systems & Additives, 10 Thickeners and Stabilizers, 8 Empty Capsules, 8 Solubilizers, 6 Taste Masking, 6 Controlled & Modified Release, 5 Disintegrants & Superdisintegrants, 5 Film Formers & Plasticizers, 4 Parenteral, 4 Topical, 4 Emulsifying Agents, 3 Coloring Agents, 3 Chewable & Orodispersible Aids, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

18 NEWS #PharmaBuzz

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18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 21 Finished Drug Prices

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2 US Medicaid Prescriptions
21 Finished Drug Prices

MARKET PLACE

8 APIs, 1 FDF Dossiers

marketPlace
8 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

5 EDQM , 5 USP , 8 Others

otherSolutions
5 EDQM
5 USP
8 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 384

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

132

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

33,171,557

Annual Reports (USD Million)

Finished Drug Prices

110 RELATED EXCIPIENT COMPANIES

185EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 17321-77-6, Clomipramine hcl, Anafranil, 3-(3-chloro-10,11-dihydro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethylpropan-1-amine hydrochloride, Chlorimipramine hydrochloride, 3-chloroimipramine hydrochloride

Molecular Formula

C₁₉H₂₄Cl₂N₂

Molecular Weight

351.3 g/mol

InChI Key

WIMWMKZEIBHDTH-UHFFFAOYSA-N

FDA UNII

2LXW0L6GWJ

A tricyclic antidepressant similar to IMIPRAMINE that selectively inhibits the uptake of serotonin in the brain. It is readily absorbed from the gastrointestinal tract and demethylated in the liver to form its primary active metabolite, desmethylclomipramine.

1 2D Structure

Clomipramine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

3-(2-chloro-5,6-dihydrobenzo[b][1]benzazepin-11-yl)-N,N-dimethylpropan-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C19H23ClN2.ClH/c1-21(2)12-5-13-22-18-7-4-3-6-15(18)8-9-16-10-11-17(20)14-19(16)22;/h3-4,6-7,10-11,14H,5,8-9,12-13H2,1-2H3;1H

2.1.3 InChI Key

WIMWMKZEIBHDTH-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN(C)CCCN1C2=CC=CC=C2CCC3=C1C=C(C=C3)Cl.Cl

2.2 Other Identifiers

2.2.1 UNII

2LXW0L6GWJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Anafranil

2. Chlomipramine

3. Chlorimipramine

4. Clomipramine

5. Clomipramine Maleate (1:1)

6. Clomipramine Monohydrochloride

7. Hydiphen

8. Hydrochloride, Clomipramine

9. Monohydrochloride, Clomipramine

2.3.2 Depositor-Supplied Synonyms

1. 17321-77-6

2. Clomipramine Hcl

3. Anafranil

4. 3-(3-chloro-10,11-dihydro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethylpropan-1-amine Hydrochloride

5. Chlorimipramine Hydrochloride

6. 3-chloroimipramine Hydrochloride

7. Chloroimipramine Monohydrochloride

8. Clomipramine (hydrochloride)

9. Clomipramine Monohydrochloride

10. 2lxw0l6gwj

11. Nsc-759323

12. G 34586

13. Mls000028511

14. Chebi:3755

15. G-34586

16. 3-chloro-5-(3-(dimethylamino)propyl)-10,11-dihydro-5h-dibenz(b,f)azepine Monohydrochloride

17. 5h-dibenz(b,f)azepine-5-propanamine, 3-chloro-10,11-dihydro-n,n-dimethyl-, Monohydrochloride

18. Anaphranil

19. Smr000058295

20. Anafranil (tn)

21. 3-(2-chloro-5,6-dihydrobenzo[b][1]benzazepin-11-yl)-n,n-dimethylpropan-1-amine;hydrochloride

22. (3-{5-chloro-2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-yl}propyl)dimethylamine Hydrochloride

23. 3-(3-chloro-10,11-dihydro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethylpropan-1-aminium Chloride

24. 5h-dibenz[b,f]azepine-5-propanamine, 3-chloro-10,11-dihydro-n,n-dimethyl-, Hydrochloride (1:1)

25. Anafranil Hydrochloride

26. Sr-01000003088

27. Einecs 241-344-3

28. Unii-2lxw0l6gwj

29. Cas-17321-77-6

30. Clomipramine, Hcl

31. Prestwick_72

32. Mfcd00069234

33. Vr-776

34. Cpd000058295

35. I615

36. Opera_id_368

37. Clomipramine Hydrochloride [usan:usp:jan]

38. Dsstox_cid_22633

39. Dsstox_rid_80064

40. Dsstox_gsid_42633

41. Schembl41747

42. Mls001074205

43. Mls002222159

44. Mls002548879

45. Spectrum2300061

46. Regid_for_cid_68539

47. Chembl1200710

48. Clomipramine-[d6] Hydrochloride

49. Dtxsid3042633

50. Clomipramine Hydrochloride- Bio-x

51. Hms1568f20

52. Pharmakon1600-02300061

53. Amy40405

54. Bcp28468

55. Hy-b0457

56. Tox21_301819

57. Tox21_500307

58. Ccg-39492

59. Nsc759323

60. S2541

61. Anafranil Hydrochloride; Chloripramine

62. Akos015895084

63. Clomipramine Hydrochloride (anafranil)

64. Ac-8082

65. Clomipramine Hydrochloride (jp17/usp)

66. Clomipramine Hydrochloride [mi]

67. Ks-1044

68. Lp00307

69. Nc00678

70. Nsc 759323

71. (non-labelled)clomipramine-13c-d3 Hcl

72. Clomipramine Hydrochloride [jan]

73. Clomipramine Hydrochloride [usan]

74. Ncgc00093756-01

75. Ncgc00093756-02

76. Ncgc00093756-03

77. Ncgc00093756-04

78. Ncgc00178275-01

79. Ncgc00178275-02

80. Ncgc00255897-01

81. Ncgc00260992-01

82. 5h-dibenz(b,f)azepine, 10,11-dihydro-3-chloro-5-(3-(dimethylamino)propyl)-, Monohydrochloride

83. Bc164325

84. Clomipramine Hydrochloride [mart.]

85. Clomipramine Hydrochloride [vandf]

86. Clomipramine Hydrochloride [usp-rs]

87. Clomipramine Hydrochloride [who-dd]

88. Eu-0100307

89. Ft-0623989

90. Sw196384-4

91. C 7291

92. Clomipramine Hydrochloride [green Book]

93. Clomipramine Hydrochloride [orange Book]

94. D00811

95. Mls-0090819.0001

96. Clomipramine Hydrochloride [ep Monograph]

97. 321c776

98. Clomipramine Hydrochloride [usp Monograph]

99. Clomipramine Hydrochloride, >=98% (hplc), Powder

100. Sr-01000003088-2

101. Sr-01000003088-4

102. Sr-01000003088-5

103. Sr-01000003088-9

104. Q27106187

105. Clomipramine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

106. Clomipramine Hydrochloride, British Pharmacopoeia (bp) Reference Standard

107. 3-chloro-10,11-dihydro-n,n-dimethyl-5h-dibenz(z)[b,f]azepine-5-propanamine Hydrochloride

108. Clomipramine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

109. Clomipramine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

110. 3-(3-chloro-10,11-dihydro-5h-dibenzo[b,f]azepin-5-yl)-n,n-dimethylpropan-1-amine Hcl

111. Clomipramine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

112. Clomipramine Hydrochloride, For Microbiological Assay, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₄Cl₂N₂
Molecular Weight	351.3 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	4
Exact Mass	350.1316542 g/mol
Monoisotopic Mass	350.1316542 g/mol
Topological Polar Surface Area	6.5 Å²
Heavy Atom Count	23
Formal Charge	0
Complexity	346
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Anafranil
PubMed Health	Clomipramine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Anafranil (clomipramine hydrochloride) Capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Anafranil is available as capsules of 25, 50, and 75 mg for oral a...
Active Ingredient	Clomipramine hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	75mg; 25mg; 50mg
Market Status	Prescription
Company	Mallinckrodt

2 of 4
Drug Name	Clomipramine hydrochloride
Drug Label	Clomipramine hydrochloride capsules USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50 and 75 mg for oral...
Active Ingredient	Clomipramine hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	75mg; 25mg; 50mg
Market Status	Prescription
Company	Teva; Taro; Sandoz; Mylan

3 of 4
Drug Name	Anafranil
PubMed Health	Clomipramine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Anafranil (clomipramine hydrochloride) Capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Anafranil is available as capsules of 25, 50, and 75 mg for oral a...
Active Ingredient	Clomipramine hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	75mg; 25mg; 50mg
Market Status	Prescription
Company	Mallinckrodt

4 of 4
Drug Name	Clomipramine hydrochloride
Drug Label	Clomipramine hydrochloride capsules USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50 and 75 mg for oral...
Active Ingredient	Clomipramine hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	75mg; 25mg; 50mg
Market Status	Prescription
Company	Teva; Taro; Sandoz; Mylan

4.2 Drug Indication

As an aid in the treatment of separation related disorders in dogs manifested by destruction and inappropriate elimination (defecation and urination) and only in combination with behavioural modification techniques.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antidepressive Agents, Tricyclic

Substances that contain a fused three-ring moiety and are used in the treatment of depression. These drugs block the uptake of norepinephrine and serotonin into axon terminals and may block some subtypes of serotonin, adrenergic, and histamine receptors. However, the mechanism of their antidepressant effects is not clear because the therapeutic effects usually take weeks to develop and may reflect compensatory changes in the central nervous system. (See all compounds classified as Antidepressive Agents, Tricyclic.)

Selective Serotonin Reuptake Inhibitors

Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Tricyclic Antidepressant [EPC]

5.3 ATC Code

QN06AA04

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API Reference Price

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LUNDBECK AS","supplierCountry":"ITALY","foreign_port":"VENICE","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"12.75","actualQuantity":"12.75","unit":"KGS","unitRateFc":"850","totalValueFC":"11919.1","currency":"EUR","unitRateINR":"78412.5","date":"05-Aug-2024","totalValueINR":"999759.38","totalValueInUsd":"11919.1","indian_port":"Bombay Air","hs_no":"29212990","bill_no":"4889529","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"VENICE","supplierAddress":"A.QUARTA STRDA 235129 PADOVASDNFSDNF ITALY","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722796200,"product":"CLOMIPRAMINE HYDROCHLORIDE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"H. LUNDBECK AS","supplierCountry":"ITALY","foreign_port":"VENICE","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"16.85","actualQuantity":"16.85","unit":"KGS","unitRateFc":"850","totalValueFC":"15752","currency":"EUR","unitRateINR":"78412.5","date":"05-Aug-2024","totalValueINR":"1321250.63","totalValueInUsd":"15752","indian_port":"Bombay Air","hs_no":"29212990","bill_no":"4889529","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"VENICE","supplierAddress":"A.QUARTA STRDA 235129 PADOVASDNFSDNF ITALY","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"CLOMIPRAMINE HYDROCHLORIDE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"LUNDBACK PHARMACEUTICALS ITALY S.P.A.","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"920.9","totalValueFC":"139857.2","currency":"USD","unitRateINR":"78134.7","date":"03-Sep-2024","totalValueINR":"11720202","totalValueInUsd":"139857.2","indian_port":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","hs_no":"29339990","bill_no":"1002112","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"CLOMIPRAMINE HYDROCHLORIDE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"H. LUNDBECK AS","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"151.58","actualQuantity":"151.58","unit":"KGS","unitRateFc":"790","totalValueFC":"128846.7","currency":"EUR","unitRateINR":"71732","date":"18-Nov-2024","totalValueINR":"10873136.56","totalValueInUsd":"128846.7","indian_port":"Bombay Air","hs_no":"29212990","bill_no":"6737620","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"A.QUARTA STRDA 235129 PADOVA SDNF SDNF ITALY","customerAddress":"ALEMBIC ROAD"}]

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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DOSAGE - CAPSULE;ORAL - 25MG

USFDA APPLICATION NUMBER - 19906

DOSAGE - CAPSULE;ORAL - 50MG

USFDA APPLICATION NUMBER - 19906

DOSAGE - CAPSULE;ORAL - 75MG

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ABOUT THIS PAGE

Clomipramine Hydrochloride Manufacturers

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

Clomipramine Hydrochloride Suppliers

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

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

Clomipramine Hydrochloride USDMF

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

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

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

Clomipramine 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 Clomipramine Hydrochloride Drug Master File in Japan (Clomipramine Hydrochloride JDMF) empowers Clomipramine 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 Clomipramine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Clomipramine 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 Clomipramine Hydrochloride suppliers with JDMF on PharmaCompass.

Clomipramine Hydrochloride KDMF

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

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

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

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

Clomipramine Hydrochloride CEP

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

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

Clomipramine Hydrochloride WC

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

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

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

Finished drug products

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

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

Clomipramine Hydrochloride GMP

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

Clomipramine Hydrochloride CoA

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

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

Clomipramine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Clomipramine Hydrochloride EP), Clomipramine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clomipramine 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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CAPSULE;ORAL - 25MG

CAPSULE;ORAL - 50MG

CAPSULE;ORAL - 75MG

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