Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
01 1Pharmathen SA
02 1Ajanta Pharma Limited
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Aurore Life Sciences
06 1Calyx Chemicals & Pharmaceuticals Limited
07 3Charioteer
08 1Cipla
09 1CordenPharma
10 1Hetero Drugs
11 1Maithri Drugs
12 4Olon S.p.A
13 2RANBAXY LABORATORIES LIMITED
14 1Shanghai Pharma Group
15 2Viatris
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-07
Pay. Date : 2017-04-28
DMF Number : 31546
Submission : 2017-05-12
Status :
Type : II
A Valcyte manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valcyte, including repackagers and relabelers. The FDA regulates Valcyte manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valcyte 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 Valcyte manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valcyte supplier is an individual or a company that provides Valcyte active pharmaceutical ingredient (API) or Valcyte finished formulations upon request. The Valcyte suppliers may include Valcyte API manufacturers, exporters, distributors and traders.
click here to find a list of Valcyte suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valcyte DMF (Drug Master File) is a document detailing the whole manufacturing process of Valcyte active pharmaceutical ingredient (API) in detail. Different forms of Valcyte DMFs exist exist since differing nations have different regulations, such as Valcyte USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valcyte DMF submitted to regulatory agencies in the US is known as a USDMF. Valcyte USDMF includes data on Valcyte's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valcyte USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valcyte suppliers with USDMF on PharmaCompass.
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