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Doxepin Hydrochloride

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

14 API Suppliers, 8 USDMF, 6 CEP/COS, 5 EU WC, 13 NDC API, 5 Listed Suppliers, $ API Reference Price

14 API Suppliers
8 USDMF
6 CEP/COS
5 EU WC
13 NDC API
5 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

190 FDF Dossiers, 180 FDA Orange Book, 7 Canada, 3 Listed Dossiers

190 FDF Dossiers
180 FDA Orange Book
7 Canada
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 9 DKSH, 3 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 9 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 18 BASF, 2 DFE Pharma, 3 Finar, 6 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 8 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 2 Nomisma Healthcare, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 24 Roquette, 2 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

41 Fillers, Diluents & Binders, 22 Thickeners and Stabilizers, 21 Direct Compression, 19 Topical, 16 Coating Systems & Additives, 15 Co-Processed Excipients, 14 Film Formers & Plasticizers, 13 Controlled & Modified Release, 13 Lubricants & Glidants, 12 Taste Masking, 10 Parenteral, 10 Granulation, 9 Disintegrants & Superdisintegrants, 9 Solubilizers, 8 Empty Capsules, 7 Chewable & Orodispersible Aids, 4 Emulsifying Agents, 3 Coloring Agents, 1 Rheology Modifiers, 1 Soft Gelatin, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

20 NEWS #PharmaBuzz

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20 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 8 Finished Drug Prices

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1 US Medicaid Prescriptions
8 Finished Drug Prices

MARKET PLACE

2 APIs

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2 APIs

PATENTS & EXCLUSIVITIES

32 US Patents

patents
32 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 1 Others

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1 EDQM
1 USP
1 Others

ANALYTICAL

1 Analytical Methods

otherMethods
1 Analytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 226

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

190

FDF Dossiers

180

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

3DRUGS 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)

1,379,343

Annual Reports (USD Million)

Finished Drug Prices

153 RELATED EXCIPIENT COMPANIES

250EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1229-29-4, Doxepin hcl, (e)-doxepin hydrochloride, 4698-39-9, Curatin, Novoxapin

Molecular Formula

C₁₉H₂₂ClNO

Molecular Weight

315.8 g/mol

InChI Key

MHNSPTUQQIYJOT-SJDTYFKWSA-N

FDA UNII

CU61C5RH24

A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.

1 2D Structure

Doxepin Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C19H21NO.ClH/c1-20(2)13-7-11-17-16-9-4-3-8-15(16)14-21-19-12-6-5-10-18(17)19;/h3-6,8-12H,7,13-14H2,1-2H3;1H/b17-11+;

2.1.3 InChI Key

MHNSPTUQQIYJOT-SJDTYFKWSA-N

2.1.4 Canonical SMILES

CN(C)CCC=C1C2=CC=CC=C2COC3=CC=CC=C31.Cl

2.1.5 Isomeric SMILES

CN(C)CC/C=C/1\C2=CC=CC=C2COC3=CC=CC=C31.Cl

2.2 Other Identifiers

2.2.1 UNII

CU61C5RH24

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Apo Doxepin

2. Apo-doxepin

3. Apodoxepin

4. Aponal

5. Deptran

6. Desidox

7. Doneurin

8. Doxepia

9. Doxepin

10. Doxepin Beta

11. Doxepin Hydrochloride, Cis-trans Isomer Mixture (approximately 1:5)

12. Doxepin Rph

13. Doxepin-rph

14. Espadox

15. Hydrochloride, Doxepin

16. Mareen

17. Novo Doxepin

18. Novo-doxepin

19. Prudoxin

20. Quitaxon

21. Sinequan

22. Sinquan

23. Xepin

24. Zonalon

2.3.2 Depositor-Supplied Synonyms

1. 1229-29-4

2. Doxepin Hcl

3. (e)-doxepin Hydrochloride

4. 4698-39-9

5. Curatin

6. Novoxapin

7. Silenor

8. Sinequan

9. Adapin

10. Aponal

11. Toruan

12. Doxepine Hydrochloride

13. Novoxapin Hydrochloride

14. Doxepin (hydrochloride)

15. Mls000069794

16. Cu61c5rh24

17. Mf 10 Hcl

18. Smr000058230

19. Sinequan (tn)

20. Nsc-108160

21. Dsstox_cid_25145

22. Dsstox_rid_80701

23. Dsstox_gsid_45145

24. Quitaxon

25. Sinequin

26. P-3693a

27. (3e)-3-(6h-benzo[c][1]benzoxepin-11-ylidene)-n,n-dimethylpropan-1-amine;hydrochloride

28. 3-(dibenzo[b,e]oxepin-11(6h)-ylidene)-n,n-dimethylpropan-1-amine Hydrochloride

29. Sr-01000075551

30. Ncgc00015344-03

31. Einecs 214-966-8

32. Cas-1229-29-4

33. Trans-doxepin Hydrochloride

34. Unii-3u9a0fe9n5

35. Unii-cu61c5rh24

36. Doxepin Hydrochloride (e)-isomer

37. (e)-3-(dibenzo[b,e]oxepin-11(6h)-ylidene)-n,n-dimethylpropan-1-amine Hydrochloride

38. Doxepin Hydrochloride [usan:usp]

39. Prestwick_187

40. Zonalon (tn)

41. (e)-doxepin Hcl

42. Mfcd00079135

43. Opera_id_675

44. 1-propanamine, 3-dibenz(b,e)oxepin-11(6h)ylidene-n,n-dimethyl-, Hydrochloride

45. 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin Hydrochloride

46. N,n-dimethyldibenz(b,e)oxepin-delta(sup 11(6h),gamma)-propylamine Hydrochloride

47. Doxepin Hydrochloride (usp)

48. Schembl60287

49. Mls001148235

50. Mls002207250

51. Mls002222181

52. Mls002548858

53. Doxepin For System Suitability

54. E-doxepin Hydrochloride

55. 3u9a0fe9n5

56. Chebi:4711

57. Chembl1200462

58. Dtxsid8045145

59. Hms1568f08

60. Hy-b0725

61. Doxepin Hydrochloride, (e)-

62. Tox21_110130

63. Tox21_500339

64. S3120

65. Akos015895087

66. Dibenz(b,e)oxepin-delta11(6h),gamma-propylamine, N,n-dimethyl-, Hydrochloride

67. Tox21_110130_1

68. Ccg-220263

69. Ccg-221643

70. Ks-5094

71. Lp00339

72. Nc00447

73. Dibenz(b,e)oxepin-delta(sup 11(6h),gamma)-propylamine, N,n-dimethyl-, Hydrochloride

74. Ncgc00024623-04

75. Ncgc00093778-01

76. Ncgc00093778-02

77. Ncgc00261024-01

78. Bd166235

79. Eu-0100339

80. D 4526

81. D00814

82. 229d294

83. A804993

84. Q-201044

85. Sr-01000075551-1

86. Sr-01000075551-5

87. Q27275787

88. Doxepin Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

89. Doxepin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

90. Doxepin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

91. (3e)-3-(6h-benzo[c][1]benzoxepin-11-ylidene)-n,n-dimethyl-1-propanamine Hydrochloride

92. (3e)-3-(6h-benzo[c][1]benzoxepin-11-ylidene)-n,n-dimethyl-propan-1-amine Hydrochloride

93. Doxepin For System Suitability, European Pharmacopoeia (ep) Reference Standard

94. Doxepin Hydrochloride, ~85% E-isomer Basis, >=98% (gc), 15% Z-isomer Basis, Powder

95. 1-propanamine, 3-dibenz(b,e)oxepin-11(6h)-ylidene-n,n-dimethyl-, Hydrochloride (1:1), (3e)-

96. 1-propanamine, 3-dibenz(b,e)oxepin-11-(6h)-ylidene-n,n-dimethyl-dimethyl-, Hydrochloride, (e)-

2.4 Create Date

2006-04-14

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₂ClNO
Molecular Weight	315.8 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	3
Exact Mass	315.1389920 g/mol
Monoisotopic Mass	315.1389920 g/mol
Topological Polar Surface Area	12.5 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	363
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Doxepin hydrochloride
PubMed Health	Doxepin
Drug Classes	Antianxiety, Antidepressant, Antiulcer, Dermatological Agent, Sleep Aid
Drug Label	Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white crystalline solid readily soluble in w...
Active Ingredient	Doxepin hydrochloride
Dosage Form	Tablet; Concentrate; Capsule
Route	oral; Oral
Strength	eq 100mg base; eq 50mg base; 6mg; eq 6mg base; eq 150mg base; eq 10mg base; eq 10mg base/ml; eq 25mg base; 3mg; eq 3mg base; eq 75mg base
Market Status	Tentative Approval; Prescription
Company	Wockhardt; Mylan Pharms; Silarx; Actavis Elizabeth; Teva Pharms; Zydus Pharms Usa; Par Pharm; Mylan

2 of 6
Drug Name	Silenor
PubMed Health	Doxepin
Drug Classes	Antianxiety, Antidepressant, Antiulcer, Dermatological Agent, Sleep Aid
Drug Label	Silenor (doxepin) is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6mg of doxepin, respectively.Chemically, doxepin hydrochloride is an (E) a...
Active Ingredient	Doxepin hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 6mg base; eq 3mg base
Market Status	Prescription
Company	Pernix Theraps

3 of 6
Drug Name	Zonalon
Drug Label	Zonalon (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin).Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant com...
Active Ingredient	Doxepin hydrochloride
Dosage Form	Cream
Route	Topical
Strength	5%
Market Status	Prescription
Company	Fougera Pharms

4 of 6
Drug Name	Doxepin hydrochloride
PubMed Health	Doxepin
Drug Classes	Antianxiety, Antidepressant, Antiulcer, Dermatological Agent, Sleep Aid
Drug Label	Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 316. It is a white crystalline solid readily soluble in w...
Active Ingredient	Doxepin hydrochloride
Dosage Form	Tablet; Concentrate; Capsule
Route	oral; Oral
Strength	eq 100mg base; eq 50mg base; 6mg; eq 6mg base; eq 150mg base; eq 10mg base; eq 10mg base/ml; eq 25mg base; 3mg; eq 3mg base; eq 75mg base
Market Status	Tentative Approval; Prescription
Company	Wockhardt; Mylan Pharms; Silarx; Actavis Elizabeth; Teva Pharms; Zydus Pharms Usa; Par Pharm; Mylan

5 of 6
Drug Name	Silenor
PubMed Health	Doxepin
Drug Classes	Antianxiety, Antidepressant, Antiulcer, Dermatological Agent, Sleep Aid
Drug Label	Silenor (doxepin) is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6mg of doxepin, respectively.Chemically, doxepin hydrochloride is an (E) a...
Active Ingredient	Doxepin hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 6mg base; eq 3mg base
Market Status	Prescription
Company	Pernix Theraps

6 of 6
Drug Name	Zonalon
Drug Label	Zonalon (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin).Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant com...
Active Ingredient	Doxepin hydrochloride
Dosage Form	Cream
Route	Topical
Strength	5%
Market Status	Prescription
Company	Fougera Pharms

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Histamine Antagonists

Drugs that bind to but do not activate histamine receptors, thereby blocking the actions of histamine or histamine agonists. Classical antihistaminics block the histamine H1 receptors only. (See all compounds classified as Histamine Antagonists.)

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.)

Sleep Aids, Pharmaceutical

Drugs used to induce SLEEP, prevent SLEEPLESSNESS, or treat SLEEP INITIATION AND MAINTENANCE DISORDERS. (See all compounds classified as Sleep Aids, Pharmaceutical.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Tricyclic Antidepressant [EPC]

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API Reference Price

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GUJARAT","supplier":"M\/S.DIPHARMA FRANCIES S.R.L","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"105.00","actualQuantity":"105","unit":"KGS","unitRateFc":"350","totalValueFC":"40652.8","currency":"EUR","unitRateINR":"32532.5","date":"23-Oct-2024","totalValueINR":"3415912.5","totalValueInUsd":"40652.8","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"6286775","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA BISSONE 5 20021 BARANZATE MILAN O-20021, MILAN SDNF ITALY","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732300200,"product":"DOXEPIN HYDROCHLORIDE (BATCH NO.2407795)","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"SEGRATE","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"305","totalValueFC":"77119.1","currency":"USD","unitRateINR":"26031.8","date":"23-Nov-2024","totalValueINR":"6507937.5","totalValueInUsd":"77119.1","indian_port":"Dahez-SEZ","hs_no":"29329990","bill_no":"6846621","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE","supplierAddress":"VIA BISSONE 5 20021 BARANZATE(MI) SDNF Italy","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"500296 DOXEPIN HYDROCHLORIDE (DOXEPIN HCL)","address":"236, OKHLA INDUSTRIAL AREA,PHASE.","city":"NEW DELHI","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"18.45","actualQuantity":"18.45","unit":"KGS","unitRateFc":"275","totalValueFC":"5459.3","currency":"EUR","unitRateINR":"24970","date":"28-Nov-2024","totalValueINR":"460696.5","totalValueInUsd":"5459.3","indian_port":"Delhi Air","hs_no":"29329990","bill_no":"6940914","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIA BISSONE 5 20021 BARANZATE MI IT SDNF ITALY","customerAddress":"236, OKHLA INDUSTRIAL AREA,PHASE."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"500296 DOXEPIN HYDROCHLORIDE (DOXEPIN HCL)","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"21.62","actualQuantity":"21.62","unit":"KGS","unitRateFc":"275","totalValueFC":"6397.2","currency":"EUR","unitRateINR":"24970","date":"28-Nov-2024","totalValueINR":"539851.4","totalValueInUsd":"6397.2","indian_port":"Delhi Air","hs_no":"29329990","bill_no":"6940914","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIA BISSONE 5 20021 BARANZATE MI IT SDNF ITALY","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"DOXEPIN HYDROCHLORIDE (BATCH NO.2407795)","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"SEGRATE","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"305","totalValueFC":"15423.8","currency":"USD","unitRateINR":"26031.8","date":"28-Nov-2024","totalValueINR":"1301587.5","totalValueInUsd":"15423.8","indian_port":"Dahez-SEZ","hs_no":"29329990","bill_no":"6928135","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE","supplierAddress":"VIA BISSONE 5 20021 BARANZATE(MI) SDNF Italy","customerAddress":"98, GOVT.INDUSTRIAL AREA,"}]

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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ABOUT THIS PAGE

Doxepin Hydrochloride Manufacturers

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

Doxepin Hydrochloride Suppliers

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

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

Doxepin Hydrochloride USDMF

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

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

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

Doxepin Hydrochloride CEP

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

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

Doxepin Hydrochloride WC

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

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

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

Finished drug products

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

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

Doxepin Hydrochloride GMP

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

Doxepin Hydrochloride CoA

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

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

Doxepin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Doxepin Hydrochloride EP), Doxepin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Doxepin 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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14 API Suppliers

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6 CEP/COS

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13 NDC API

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