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List of Drug Master Files (DMF) of Varenicline L-Tartrate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Dr. Reddy's Laboratories (1)

02 Piramal Pharma Solutions (1)

03 Teva API (1)

04 ALP Pharm (1)

05 Actavis Inc (1)

06 Amoli Organics (1)

07 Apotex Pharmachem (1)

08 Centaur Pharmaceuticals (1)

09 Enaltec Labs Private Limited (1)

10 Hetero Drugs (1)

11 Jubilant Generics (1)

12 Lee Pharma (2)

13 Lupin Ltd (1)

14 Macleods Pharmaceuticals Limited (1)

15 Maithri Drugs (1)

16 Shilpa Medicare (1)

17 Viatris (1)

18 Viwit Pharmaceuticals Limited (2)

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01 VARENICLINE BASE (INTERMEDIATE OF VARENICLINE) (1)

02 VARENICLINE TARTRATE (15)

03 VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE (1)

04 VARENICLINE TARTRATE (DRUG SUBSTANCE, NON-STERILE) (1)

05 VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)] (1)

06 Varenicline Tartrate (1)

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01 Canada (1)

02 China (3)

03 India (12)

04 Ireland (1)

05 Israel (1)

06 U.S.A (2)

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01 Active (18)

02 Inactive (2)

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01 Complete (11)

02 Blank (9)

URL Supplier Web Content
34116
Active
2020-01-30
Complete
2020-03-20
2020-02-18
II
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URL Supplier Web Content
23708
Active
2010-04-12
Complete
2012-11-23
2012-11-13
II
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URL Supplier Web Content
23791
Active
2010-05-06
N/A
II
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URL Supplier Web Content
23774
Active
2010-05-05
N/A
II
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URL Supplier Web Content
32682
Active
2018-03-30
N/A
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URL Supplier Web Content
31576
Active
2017-03-30
N/A
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URL Supplier Web Content
31513
Active
2017-04-13
Complete
2017-05-15
2017-04-27
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URL Supplier Web Content
23441
Active
2010-01-12
N/A
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URL Supplier Web Content
32638
Active
2018-02-22
Complete
2018-10-31
2018-09-11
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Looking for 375815-87-5 / Varenicline API manufacturers, exporters & distributors?

Varenicline manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Varenicline 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 Varenicline manufacturer or Varenicline supplier for your needs.

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

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

API | Excipient name

Varenicline

Synonyms

Varenicline tartrate, 375815-87-5, (2s,3s)-2,3-dihydroxybutanedioic acid; 5,8,14-triazatetracyclo[10.3.1.0^{2,11}.0^{4,9}]hexadeca-2(11),3,5,7,9-pentaene, (2s,3s)-2,3-dihydroxybutanedioic acid;5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaene, Akos026750167, As-35136

Cas Number

375815-87-5

About Varenicline

A benzazepine derivative that functions as an ALPHA4-BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.

Varenicline L-Tartrate Manufacturers

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

Varenicline L-Tartrate Suppliers

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

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

Varenicline L-Tartrate USDMF

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

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

click here to find a list of Varenicline L-Tartrate suppliers with USDMF on PharmaCompass.

Varenicline L-Tartrate Manufacturers | Traders | Suppliers

Varenicline L-Tartrate Manufacturers, Traders, Suppliers 1
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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