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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

40 API Suppliers, 32 USDMF, 14 CEP/COS, 2 JDMF, 5 EU WC, 47 KDMF, 11 NDC API, 7 Listed Suppliers, $ API Reference Price

40 API Suppliers
32 USDMF
14 CEP/COS
2 JDMF
5 EU WC
47 KDMF
11 NDC API
7 Listed Suppliers
$ API Reference Price

INTERMEDIATES

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1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

170 FDF Dossiers, 121 FDA Orange Book, 21 Europe, 9 Canada, 19 Listed Dossiers

170 FDF Dossiers
121 FDA Orange Book
21 Europe
9 Canada
19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 25MG BASE/ML, TABLET;ORAL - EQ 75MG BASE, TABLET;ORAL - EQ 150MG BASE

drugProductComposition
TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 25MG BASE/ML
TABLET;ORAL - EQ 75MG BASE
TABLET;ORAL - EQ 150MG BASE

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5 Rochem International Inc
8 SPI Pharma
2 Seqens
9 DKSH
1 Pharm-RX Chemical
7 Faran Shimi Pharmaceutical
3 Boai NKY Pharmaceuticals Ltd
15 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
4 ACG Worldwide
13 Actylis
1 Aeon Procare
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
16 BASF
1 Bioplus Life Sciences
1 Clariant
10 Corel Pharma Chem
6 DFE Pharma
3 Finar
9 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
29 Kerry
3 Kima Chemical
6 Lonza Capsugel
10 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
1 Novo Excipients
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8 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
32 Roquette
13 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
2 The Dow Chemical Company
1 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
1 Vertellus
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 30 Direct Compression, 28 Thickeners and Stabilizers, 28 Disintegrants & Superdisintegrants, 27 Controlled & Modified Release, 23 Film Formers & Plasticizers, 23 Taste Masking, 20 Solubilizers, 20 Parenteral, 19 Granulation, 17 Topical, 17 Lubricants & Glidants, 17 Co-Processed Excipients, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 Emulsifying Agents, 7 API Stability Enhancers, 5 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 118 NEWS #PharmaBuzz

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3 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
118 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 Finished Drug Prices, 3 Annual Reports

globalSalesInformation
7 Finished Drug Prices
3 Annual Reports

MARKET PLACE

19 APIs

marketPlace
19 APIs

PATENTS & EXCLUSIVITIES

15 Health Canada Patents

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15 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 2 JP , 1 Others

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3 EDQM
1 USP
2 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

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EU WC

KDMF

NDC API

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API REF. PRICE (USD/KG)

$ 22

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170

FDF Dossiers

121

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News #PharmaBuzz

GLOBAL SALES INFORMATION

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Annual Reports (USD Million)

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Finished Drug Prices

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443EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Ranitidine hydrochloride, 66357-59-3, 71130-06-8, Fendibina, Gastridina, Gastrolav

Molecular Formula

C₁₃H₂₃ClN₄O₃S

Molecular Weight

350.87 g/mol

InChI Key

GGWBHVILAJZWKJ-KJEVSKRMSA-N

A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.

1 2D Structure

Ranitidine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(E)-1-N'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine;hydrochloride

2.1.2 InChI

InChI=1S/C13H22N4O3S.ClH/c1-14-13(9-17(18)19)15-6-7-21-10-12-5-4-11(20-12)8-16(2)3;/h4-5,9,14-15H,6-8,10H2,1-3H3;1H/b13-9+;

2.1.3 InChI Key

GGWBHVILAJZWKJ-KJEVSKRMSA-N

2.1.4 Canonical SMILES

CNC(=C[N+](=O)[O-])NCCSCC1=CC=C(O1)CN(C)C.Cl

2.1.5 Isomeric SMILES

CN/C(=C\[N+](=O)[O-])/NCCSCC1=CC=C(O1)CN(C)C.Cl

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Ah 19065

2. Ah-19065

3. Ah19065

4. Biotidin

5. Hydrochloride, Ranitidine

6. N (2-(((5-((dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-n'-methyl-2-nitro-1,1-ethenediamine

7. Ranisen

8. Ranitidin

9. Ranitidine

10. Ranitidine Hydrochloride

11. Sostril

12. Zantac

13. Zantic

2.2.2 Depositor-Supplied Synonyms

1. Ranitidine Hydrochloride

2. 66357-59-3

3. 71130-06-8

4. Fendibina

5. Gastridina

6. Gastrolav

7. Kuracid

8. Raniberl

9. Ranibloc

10. Alquen

11. Rani-nerton

12. Zantac

13. Nu-ranit

14. Rani-q

15. Ranitidine (hydrochloride)

16. Santanol

17. Tanidina

18. Toriol

19. Coralen

20. Quantor

21. Radin

22. Chebi:8777

23. Gastrial

24. Raniben

25. Ranibeta

26. Azantac

27. Zantac (tn)

28. (e)-1-n'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-1-n-methyl-2-nitroethene-1,1-diamine;hydrochloride

29. Mfcd00941509

30. {2-[({5-[(dimethylamino)methyl]furan-2-yl}methyl)sulfanyl]ethyl}[(z)-1-(methylamino)-2-nitroethenyl]amine Hydrochloride

31. Smr000653467

32. (e)-n-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n-methyl-2-nitroethene-1,1-diamine

33. N-(2-((5-((dimethylamino)methyl)furfuryl)thio)ethyl)-n'-methyl-2-nitrovinylidenediamine Monohydrochloride

34. C13h22n4o3s.hcl

35. Zantic

36. Zantac;noctone

37. Sr-01000075288

38. Ah19065

39. Ah-19065

40. Prestwick_635

41. Einecs 275-207-4

42. Ranitidine (zantac)

43. Ranitidine Hydrochloride 100 Microg/ml In Acetonitrile

44. Epitope Id:127516

45. Mls001146938

46. Mls002548856

47. Chembl1092473

48. Hy-b0281a

49. Hms1568j03

50. Amy24712

51. Bcp28420

52. N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-n'-methyl-2-nitro-1,1-ethenediamine Hydrochloride

53. N-[2-[5-[(dimethylamino)methyl]furfurylthio]ethyl]-n'-methyl-2-nitro-1,1-ethenediamine Hydrochloride

54. Tox21_501073

55. S1801

56. Ranitidine Hydrochloride (jp17/usp)

57. Akos015895250

58. Ccg-212946

59. Lp01073

60. Nc00479

61. Ranitidine For Impurity A Identification

62. Ncgc00094351-01

63. Ncgc00261758-01

64. Ac-12743

65. N-[2-[[5-(dimethylaminomethyl)furan-2-yl]methylsulfanyl]ethyl]-n'-methyl-2-nitroethene-1,1-diamine Hydrochloride

66. Eu-0101073

67. R-101

68. R0073

69. Sw196800-3

70. Bim-0051043.0001

71. D00673

72. 357n593

73. A835435

74. Sr-01000075288-2

75. W-104534

76. (e)-n-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n'-methyl-2-nitroethene-1,1-diamine Hydrochloride

77. (e)-n1'-[2-[[5-[(dimethylamino)methyl]-2-furanyl]methylthio]ethyl]-n1-methyl-2-nitroethene-1,1-diamine Hydrochloride

78. (e)-n1'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-n1-methyl-2-nitro-ethene-1,1-diamine Hydrochloride

79. 1,1-ethenediamine, N-(2-(((5-((dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-n'-methyl-2-nitro-, Hydrochloride

80. N-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n'-methyl-2-nitroethene-1,1-diamine Hydrochloride

81. N-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n-methyl-2-nitroethene-1,1-diaminehydrochloride

82. N-(2-((5-(dimethylaminomethyl)furan-2-yl)methylsulfanyl)ethyl)-n'-methyl-2-nitroethene-1,1-diamine Hcl

83. N-[2-[[[5-[(dimethylamino)methyl]-2 -furanyl]methyl]thio]ethyl]-n'-methyl-2-nitro-1,1-e Thanediamine Hydrochloride

2.3 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₃H₂₃ClN₄O₃S
Molecular Weight	350.87 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	9
Exact Mass	350.1179395 g/mol
Monoisotopic Mass	350.1179395 g/mol
Topological Polar Surface Area	112 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	347
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 10
Drug Name	Ranitidine hydrochloride
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet; Syrup; Capsule; Injectable
Route	Injection; Oral
Strength	eq 150mg base; eq 15mg base/ml; eq 75mg base; 25mg/ml; eq 300mg base; eq 25mg base/ml
Market Status	Over the Counter; Prescription
Company	Vintage Pharms; Amneal Pharms; Wockhardt; Silarx; Breckenridge Pharm; Teva; Pharm Assoc; Apotex; Torpharm; Shasun Chems; Taro; Sandoz; Par Pharm; Perrigo R And D; Svads Holdings Sa; Glenmark Generics; Amneal Pharms Ny; Ivax Sub Teva Pharms; Hi Tech Pharma

2 of 10
Drug Name	Zantac
PubMed Health	Ranitidine (Injection)
Drug Classes	Antiulcer, Gastric Acid Secretion Inhibitor
Drug Label	The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Syrup; Injectable
Route	Injection; Oral
Strength	eq 15mg base/ml; eq 25mg base/ml
Market Status	Prescription
Company	Covis Injectables; Glaxo Grp

3 of 10
Drug Name	Zantac 150
PubMed Health	Ranitidine
Drug Classes	Antiulcer, Gastric Acid Secretion Inhibitor
Drug Label	The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 150mg base
Market Status	Over the Counter; Prescription
Company	Boehringer Ingelheim; Glaxo Grp

4 of 10
Drug Name	Zantac 300
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 300mg base
Market Status	Prescription
Company	Glaxo Grp

5 of 10
Drug Name	Zantac 75
Drug Label	The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 75mg base
Market Status	Over the Counter
Company	Boehringer Ingelheim

6 of 10
Drug Name	Ranitidine hydrochloride
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet; Syrup; Capsule; Injectable
Route	Injection; Oral
Strength	eq 150mg base; eq 15mg base/ml; eq 75mg base; 25mg/ml; eq 300mg base; eq 25mg base/ml
Market Status	Over the Counter; Prescription
Company	Vintage Pharms; Amneal Pharms; Wockhardt; Silarx; Breckenridge Pharm; Teva; Pharm Assoc; Apotex; Torpharm; Shasun Chems; Taro; Sandoz; Par Pharm; Perrigo R And D; Svads Holdings Sa; Glenmark Generics; Amneal Pharms Ny; Ivax Sub Teva Pharms; Hi Tech Pharma

7 of 10
Drug Name	Zantac
PubMed Health	Ranitidine (Injection)
Drug Classes	Antiulcer, Gastric Acid Secretion Inhibitor
Drug Label	The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Syrup; Injectable
Route	Injection; Oral
Strength	eq 15mg base/ml; eq 25mg base/ml
Market Status	Prescription
Company	Covis Injectables; Glaxo Grp

8 of 10
Drug Name	Zantac 150
PubMed Health	Ranitidine
Drug Classes	Antiulcer, Gastric Acid Secretion Inhibitor
Drug Label	The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 150mg base
Market Status	Over the Counter; Prescription
Company	Boehringer Ingelheim; Glaxo Grp

9 of 10
Drug Name	Zantac 300
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 300mg base
Market Status	Prescription
Company	Glaxo Grp

10 of 10
Drug Name	Zantac 75
Drug Label	The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
Active Ingredient	Ranitidine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	eq 75mg base
Market Status	Over the Counter
Company	Boehringer Ingelheim

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Histamine H2 Antagonists

Drugs that selectively bind to but do not activate histamine H2 receptors, thereby blocking the actions of histamine. Their clinically most important action is the inhibition of acid secretion in the treatment of gastrointestinal ulcers. Smooth muscle may also be affected. Some drugs in this class have strong effects in the central nervous system, but these actions are not well understood. (See all compounds classified as Histamine H2 Antagonists.)

Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Histamine-2 Receptor Antagonist [EPC]; Histamine H2 Receptor Antagonists [MoA]

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RANITIDINE HYDROCHLORIDE USP (RE-IMPORT VIDE SB NO.6774801 DTD. 26.11.2020","address":"4, PODAR CHAMBERS, 4TH FLOOR,109, S.A.BRELVI ROAD, FORT,","city":"MUMBAI, MAHARASHTRA","supplier":"JIAOZUO ZHONGWEN TRADE CORPORATION LIMITED","supplierCountry":"INDIA","foreign_port":"","customer":"INDOSOL EXPORTS","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"14.9","totalValueFC":"74658.2","currency":"USD","unitRateINR":"1098.2","date":"08-Jun-2021","totalValueINR":"5490787.5","totalValueInUsd":"74658.2","indian_port":"JNPT","hs_no":"29420014","bill_no":"4242702","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"4, PODAR CHAMBERS, 4TH FLOOR,109, S.A.BRELVI ROAD, FORT,"}]

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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INTERMEDIATES SUPPLIERS

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DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18703

DOSAGE - TABLET;ORAL - EQ 300MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18703

DOSAGE - INJECTABLE;INJECTION - EQ 25MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 25MG BASE/ML

USFDA APPLICATION NUMBER - 19090

DOSAGE - TABLET;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 20520

DOSAGE - TABLET;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 21698

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ABOUT THIS PAGE

Zantac Manufacturers

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

Zantac Suppliers

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

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

Zantac USDMF

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

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

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

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

Zantac KDMF

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

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

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

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

Zantac CEP

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

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

Zantac WC

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

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

Zantac 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 Zantac as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Zantac GMP

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

Zantac CoA

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

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

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

40 API Suppliers

32 USDMF

14 CEP/COS

2 JDMF

5 EU WC

47 KDMF

11 NDC API

7 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

170 FDF Dossiers

121 FDA Orange Book

21 Europe

9 Canada

19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 25MG BASE/ML

TABLET;ORAL - EQ 75MG BASE

TABLET;ORAL - EQ 150MG BASE

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EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders

49 Coating Systems & Additives

30 Direct Compression

TABLET;ORAL - EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons