DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1ALP Pharm
03 1Actavis Inc
04 1Amoli Organics
05 1Apotex Pharmachem
06 1Centaur Pharmaceuticals
07 1Charioteer
08 1Enaltec Labs Private Limited
09 1Hetero Drugs
10 1Jubilant Generics
11 1Lee Pharma
12 1Lupin Ltd
13 1Macleods Pharmaceuticals Limited
14 1Maithri Drugs
15 1Piramal Pharma Solutions
16 1Shilpa Medicare
17 1Unichem Laboratories Limited
18 1Viatris
19 2Viwit Pharmaceuticals Limited
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38693
Submission : 2023-08-30
Status :
Type : II
A Varenicline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Varenicline, including repackagers and relabelers. The FDA regulates Varenicline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Varenicline 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Varenicline supplier is an individual or a company that provides Varenicline active pharmaceutical ingredient (API) or Varenicline finished formulations upon request. The Varenicline suppliers may include Varenicline API manufacturers, exporters, distributors and traders.
click here to find a list of Varenicline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Varenicline DMF (Drug Master File) is a document detailing the whole manufacturing process of Varenicline active pharmaceutical ingredient (API) in detail. Different forms of Varenicline DMFs exist exist since differing nations have different regulations, such as Varenicline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Varenicline DMF submitted to regulatory agencies in the US is known as a USDMF. Varenicline USDMF includes data on Varenicline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Varenicline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Varenicline suppliers with USDMF on PharmaCompass.
We have 19 companies offering Varenicline
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