TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Lupin Ltd
03 1RANBAXY LABORATORIES LIMITED
04 1Viatris
01 3FOSAMPRENAVIR CALCIUM
02 1FOSAMPRENAVIR CALCIUM USP
01 2India
02 1Israel
03 1U.S.A
01 2Active
02 2Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27593
Submission : 2014-03-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25569
Submission : 2012-02-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25649
Submission : 2012-01-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-08
Pay. Date : 2014-12-26
DMF Number : 25578
Submission : 2011-11-29
Status : Active
Type : II
A Fosamprenavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosamprenavir, including repackagers and relabelers. The FDA regulates Fosamprenavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosamprenavir 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 Fosamprenavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosamprenavir supplier is an individual or a company that provides Fosamprenavir active pharmaceutical ingredient (API) or Fosamprenavir finished formulations upon request. The Fosamprenavir suppliers may include Fosamprenavir API manufacturers, exporters, distributors and traders.
click here to find a list of Fosamprenavir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosamprenavir DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosamprenavir active pharmaceutical ingredient (API) in detail. Different forms of Fosamprenavir DMFs exist exist since differing nations have different regulations, such as Fosamprenavir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosamprenavir DMF submitted to regulatory agencies in the US is known as a USDMF. Fosamprenavir USDMF includes data on Fosamprenavir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosamprenavir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosamprenavir suppliers with USDMF on PharmaCompass.
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