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Chemistry

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Also known as: 229975-97-7, Reyataz, Atazanavir sulphate, Bms-232632-05, Atazanavir (sulfate), Atazanavir sulfate [usan]
Molecular Formula
C38H54N6O11S
Molecular Weight
802.9  g/mol
InChI Key
DQSGVVGOPRWTKI-QVFAWCHISA-N
FDA UNII
4MT4VIE29P

Atazanavir Sulfate
An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS.
1 2D Structure

Atazanavir Sulfate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl N-[(2S)-1-[2-[(2S,3S)-2-hydroxy-3-[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;sulfuric acid
2.1.2 InChI
InChI=1S/C38H52N6O7.H2O4S/c1-37(2,3)31(41-35(48)50-7)33(46)40-29(22-25-14-10-9-11-15-25)30(45)24-44(43-34(47)32(38(4,5)6)42-36(49)51-8)23-26-17-19-27(20-18-26)28-16-12-13-21-39-28;1-5(2,3)4/h9-21,29-32,45H,22-24H2,1-8H3,(H,40,46)(H,41,48)(H,42,49)(H,43,47);(H2,1,2,3,4)/t29-,30-,31+,32+;/m0./s1
2.1.3 InChI Key
DQSGVVGOPRWTKI-QVFAWCHISA-N
2.1.4 Canonical SMILES
CC(C)(C)C(C(=O)NC(CC1=CC=CC=C1)C(CN(CC2=CC=C(C=C2)C3=CC=CC=N3)NC(=O)C(C(C)(C)C)NC(=O)OC)O)NC(=O)OC.OS(=O)(=O)O
2.1.5 Isomeric SMILES
CC(C)(C)[C@@H](C(=O)N[C@@H](CC1=CC=CC=C1)[C@H](CN(CC2=CC=C(C=C2)C3=CC=CC=N3)NC(=O)[C@H](C(C)(C)C)NC(=O)OC)O)NC(=O)OC.OS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
4MT4VIE29P
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 232632, Bms

2. 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioic Acid Dimethyl Ester

3. Atazanavir

4. Bms 232632

5. Bms 232632 05

6. Bms-232632

7. Bms-232632-05

8. Bms232632

9. Bms23263205

10. Cgp 73547

11. Cgp 75136

12. Cgp 75176

13. Cgp 75355

14. Cgp-73547

15. Cgp-75136

16. Cgp-75176

17. Cgp-75355

18. Cgp73547

19. Cgp75136

20. Cgp75176

21. Cgp75355

22. Reyataz

2.3.2 Depositor-Supplied Synonyms

1. 229975-97-7

2. Reyataz

3. Atazanavir Sulphate

4. Bms-232632-05

5. Atazanavir (sulfate)

6. Atazanavir Sulfate [usan]

7. Atazor

8. Atazanavir So4

9. 4mt4vie29p

10. Atazanavir Sulfate (bms-232632-05)

11. 229975-97-7 (sulfate)

12. Nsc-742546

13. 2,5,6,10,13-pentaazatetradecanedioic Acid, 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-, Dimethyl Ester, (3s,8s,9s,12s)-, Sulfate (1:1) (salt)

14. Reyataz (tn)

15. 2,5,6,10,13-pentaazatetradecanedioic Acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, Dimethyl Ester, (3s,8s,9s,12s)-, Sulfate (1:1) (salt)

16. Dimethyl (3s,8s,9s,12s)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, Sulfate (1:1) (salt)

17. Chebi:31243

18. Smr002544693

19. Atazanavir Bisulfate Salt

20. Unii-4mt4vie29p

21. Ulfuric Acid

22. Atazanaviri Sulfas

23. Mls003915641

24. Mls006010199

25. Schembl341700

26. Atazanavir So4 [vandf]

27. Atazanavir Sulfate [mi]

28. Atazanavir Sulfate (jan/usan)

29. Atazanavir Sulfate [jan]

30. Chembl1200678

31. Bms-232632-05, Reyataz

32. Dtxsid401017206

33. Atazanavir Sulfate [mart.]

34. Amy36999

35. Atazanavir Sulfate [usp-rs]

36. Atazanavir Sulfate [who-dd]

37. Atazanavir Sulfate [who-ip]

38. Ex-a4010

39. Methyl N-[(2s)-1-[2-[(2s,3s)-2-hydroxy-3-[[(2s)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;sulfuric Acid

40. Hy-17367a

41. Mfcd08067748

42. S1457

43. Akos016000176

44. Atazanavir Sulphate [ema Epar]

45. Ccg-270493

46. Cs-1890

47. Nsc 742546

48. Atazanavir Sulfate [orange Book]

49. Atazanavir Sulfate [ep Monograph]

50. As-14954

51. Atazanaviri Sulfas [who-ip Latin]

52. Evotaz Component Atazanavir Sulfate

53. Methyl ((5s,10s,11s,14s)-11-benzyl-5-(tert-butyl)-10-hydroxy-15,15-dimethyl-3,6,13-trioxo-8-(4-(pyridin-2-yl)benzyl)-2-oxa-4,7,8,12-tetraazahexadecan-14-yl)carbamate Sulfate

54. Atazanavir Sulfate Component Of Evotaz

55. Sw220258-1

56. D01276

57. 975a977

58. A816475

59. J-014934

60. 3-amino-3-(3-benzyloxy-phenyl)-propionicacid

61. Q27114238

62. 2,5,6,10,13-pentaazatetradecanedioic Acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, Dimethyl Ester, (3s,8s,9s,12s)-, Sulphate (1:1) (salt)

63. Dimethyl (3s,8s,9s,12s)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, Sulphate (1:1) (salt)

64. Dimethyl (3s,8s,9s,12s)-9-benzyl-3,12-di-tert-butyl-8-hydroxy-4,11-dioxo-6-((4-(pyridin-2-yl)phenyl)methyl)-2,5,6,10,13-pentaazatetradecanedioate Monosulfate

65. Methyl N-[(1s)-1-[[(1s,2s)-1-benzyl-2-hydroxy-3-[[[(2s)-2-(methoxycarbonylamino)-3,3-dimethyl-butanoyl]amino]-[(4-phenylphenyl)methyl]amino]propyl]carbamoyl]-2,2-dimethyl-propyl]carbamate; Sulfuric Acid;atazanavir Sulfate

66. Methyl N-[(2s)-1-[2-[(2s,3s)-2-hydroxy-3-[[(2s)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;s

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 802.9 g/mol
Molecular Formula C38H54N6O11S
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count13
Rotatable Bond Count18
Exact Mass802.35712773 g/mol
Monoisotopic Mass802.35712773 g/mol
Topological Polar Surface Area254 Ų
Heavy Atom Count56
Formal Charge0
Complexity1190
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameAtazanavir sulfate
Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
Active IngredientAtazanavir sulfate
Dosage FormCapsule
Routeoral; Oral
Strength300mg; eq 100mg base; 200mg; eq 200mg base; 100mg; eq 300mg base; 150mg; eq 150mg base
Market StatusTentative Approval; Prescription
CompanyMatrix Labs; Emcure Pharms; Aurobindo Pharma; Teva Pharms Usa; Emcure Pharma

2 of 4  
Drug NameReyataz
PubMed HealthAtazanavir (By mouth)
Drug ClassesAntiretroviral Agent, Antiviral
Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
Active IngredientAtazanavir sulfate
Dosage FormCapsule; Powder
RouteOral
Strengtheq 50mg base/packet; eq 150mg base; eq 200mg base; eq 300mg base
Market StatusPrescription
CompanyBristol Myers Squibb

3 of 4  
Drug NameAtazanavir sulfate
Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
Active IngredientAtazanavir sulfate
Dosage FormCapsule
Routeoral; Oral
Strength300mg; eq 100mg base; 200mg; eq 200mg base; 100mg; eq 300mg base; 150mg; eq 150mg base
Market StatusTentative Approval; Prescription
CompanyMatrix Labs; Emcure Pharms; Aurobindo Pharma; Teva Pharms Usa; Emcure Pharma

4 of 4  
Drug NameReyataz
PubMed HealthAtazanavir (By mouth)
Drug ClassesAntiretroviral Agent, Antiviral
Drug LabelREYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease.The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pen...
Active IngredientAtazanavir sulfate
Dosage FormCapsule; Powder
RouteOral
Strengtheq 50mg base/packet; eq 150mg base; eq 200mg base; eq 300mg base
Market StatusPrescription
CompanyBristol Myers Squibb

4.2 Drug Indication

Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4. 2).

Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations).

The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patients treatment history (see sections 4. 4 and 5. 1).

Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4. 2).

Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patients treatment history (see sections 4. 4 and 5. 1).


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

HIV Protease Inhibitors

Inhibitors of HIV PROTEASE, an enzyme required for production of proteins needed for viral assembly. (See all compounds classified as HIV Protease Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Cytochrome P450 3A Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; HIV Protease Inhibitors [MoA]; Protease Inhibitor [EPC]; UDP Glucuronosyltransferases Inhibitors [MoA]; UGT1A1 Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]
5.3 ATC Code

J05AE08


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INCOMED\\\"","customerCountry":"RUSSIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"510","totalValueFC":"248940","currency":"USD","unitRateINR":42304.364880000001,"date":"21-Dec-2024","totalValueINR":"21152182.44","totalValueInUsd":"248940","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6656613","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"T-184, MIDC, BHOSARI,, PUNE-MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"BMS 232632-05T ATAZANAVIR SULFATE , BATCH NO : ACR6349","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"E.R SQUIBB AND ","supplierCountry":"UNITED STATES","foreign_port":"JOHN F. KENNEDY APT\/NEW YORK, NY","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"230768.3","totalValueFC":"7013821.2","currency":"USD","unitRateINR":"19592226.7","date":"11-Sep-2024","totalValueINR":"587766801","totalValueInUsd":"7013821.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1002867","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"JOHN F. KENNEDY APT\/NEW YORK, NY","supplierAddress":"N\/A","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"}]
27-Feb-2021
21-Dec-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 300MG BASE;150MG

USFDA APPLICATION NUMBER - 206353

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DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21567

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

USFDA APPLICATION NUMBER - 21567

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DOSAGE - CAPSULE;ORAL - EQ 200MG BASE

USFDA APPLICATION NUMBER - 21567

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DOSAGE - CAPSULE;ORAL - EQ 300MG BASE

USFDA APPLICATION NUMBER - 21567

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ABOUT THIS PAGE

Looking for 229975-97-7 / Atazanavir Sulfate API manufacturers, exporters & distributors?

Atazanavir Sulfate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Atazanavir Sulfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Atazanavir Sulfate manufacturer or Atazanavir Sulfate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atazanavir Sulfate manufacturer or Atazanavir Sulfate supplier.

PharmaCompass also assists you with knowing the Atazanavir Sulfate API Price utilized in the formulation of products. Atazanavir Sulfate API Price is not always fixed or binding as the Atazanavir Sulfate Price is obtained through a variety of data sources. The Atazanavir Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Atazanavir Sulfate

Synonyms

229975-97-7, Reyataz, Atazanavir sulphate, Bms-232632-05, Atazanavir (sulfate), Atazanavir sulfate [usan]

Cas Number

229975-97-7

Unique Ingredient Identifier (UNII)

4MT4VIE29P

About Atazanavir Sulfate

An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS.

ATAZANAVIR SULPHATE Manufacturers

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

ATAZANAVIR SULPHATE Suppliers

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

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

ATAZANAVIR SULPHATE USDMF

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

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

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

ATAZANAVIR SULPHATE KDMF

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

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

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

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

ATAZANAVIR SULPHATE CEP

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

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

ATAZANAVIR SULPHATE WC

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

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

ATAZANAVIR SULPHATE 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 ATAZANAVIR SULPHATE as an active pharmaceutical ingredient (API).

Finished drug products

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

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

ATAZANAVIR SULPHATE GMP

ATAZANAVIR SULPHATE 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 ATAZANAVIR SULPHATE 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 ATAZANAVIR SULPHATE GMP manufacturer or ATAZANAVIR SULPHATE GMP API supplier for your needs.

ATAZANAVIR SULPHATE CoA

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

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

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