EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Cambrex Corporation
03 1Centaur Pharmaceuticals
04 2F.I.S. Fabbrica Italiana Sintetici
05 1HONOUR LAB LTD
06 1MSN Laboratories
07 1Micro Labs Limited
08 1Piramal Pharma Solutions
09 1Raks Pharma
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2013-02-13
DMF Number : 18340
Submission : 2005-05-09
Status :
Type : II
A Onfi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Onfi, including repackagers and relabelers. The FDA regulates Onfi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Onfi 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 Onfi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Onfi supplier is an individual or a company that provides Onfi active pharmaceutical ingredient (API) or Onfi finished formulations upon request. The Onfi suppliers may include Onfi API manufacturers, exporters, distributors and traders.
click here to find a list of Onfi suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Onfi DMF (Drug Master File) is a document detailing the whole manufacturing process of Onfi active pharmaceutical ingredient (API) in detail. Different forms of Onfi DMFs exist exist since differing nations have different regulations, such as Onfi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Onfi DMF submitted to regulatory agencies in the US is known as a USDMF. Onfi USDMF includes data on Onfi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Onfi USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Onfi suppliers with USDMF on PharmaCompass.
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