ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 2Cipla
05 1Fresenius Kabi AB Brunna
06 1Gador SA
07 1Hospira, Inc.
08 1Sun Pharmaceutical Industries Limited
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-19
DMF Number : 12803
Submission : 1997-12-22
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13946
Submission : 1999-01-18
Status :
Type : II
A Pamidronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pamidronic Acid, including repackagers and relabelers. The FDA regulates Pamidronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pamidronic Acid 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 Pamidronic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pamidronic Acid supplier is an individual or a company that provides Pamidronic Acid active pharmaceutical ingredient (API) or Pamidronic Acid finished formulations upon request. The Pamidronic Acid suppliers may include Pamidronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Pamidronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pamidronic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Pamidronic Acid active pharmaceutical ingredient (API) in detail. Different forms of Pamidronic Acid DMFs exist exist since differing nations have different regulations, such as Pamidronic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pamidronic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Pamidronic Acid USDMF includes data on Pamidronic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pamidronic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pamidronic Acid suppliers with USDMF on PharmaCompass.
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