Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 2Biocon
05 1Concord Biotech
06 2Daiichi Sankyo
07 1Kyowa Hakko Bio
08 2Lek Pharmaceuticals
09 1Livzon New North River Pharmaceutical
10 1RANBAXY LABORATORIES LIMITED
11 3Zhejiang Hisun Pharmaceutical
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14235
Submission : 1999-06-24
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 : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-13
DMF Number : 14729
Submission : 2000-02-25
Status :
Type : II
A Pravastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pravastatin, including repackagers and relabelers. The FDA regulates Pravastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pravastatin 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 Pravastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pravastatin supplier is an individual or a company that provides Pravastatin active pharmaceutical ingredient (API) or Pravastatin finished formulations upon request. The Pravastatin suppliers may include Pravastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Pravastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pravastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pravastatin active pharmaceutical ingredient (API) in detail. Different forms of Pravastatin DMFs exist exist since differing nations have different regulations, such as Pravastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pravastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Pravastatin USDMF includes data on Pravastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pravastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pravastatin suppliers with USDMF on PharmaCompass.
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