Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
01 1Curia
02 1ALP Pharm
03 1BrightGene Bio-Medical Technology Co.,Ltd
04 1Emcure Pharmaceuticals
05 2GLAND PHARMA LIMITED
06 1Mitsubishi Tanabe Pharma
07 1ScinoPharm Taiwan Ltd
08 1Suzhou Ryway Biotech
09 1Tianjin Weijie Pharmaceutical Co., Ltd.
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-10-25
DMF Number : 20760
Submission : 2007-08-07
Status :
Type : II
95
PharmaCompass offers a list of Argatroban API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Argatroban manufacturer or Argatroban supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Argatroban manufacturer or Argatroban supplier.
A Argatroban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban, including repackagers and relabelers. The FDA regulates Argatroban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban 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 Argatroban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Argatroban supplier is an individual or a company that provides Argatroban active pharmaceutical ingredient (API) or Argatroban finished formulations upon request. The Argatroban suppliers may include Argatroban API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Argatroban DMF (Drug Master File) is a document detailing the whole manufacturing process of Argatroban active pharmaceutical ingredient (API) in detail. Different forms of Argatroban DMFs exist exist since differing nations have different regulations, such as Argatroban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Argatroban DMF submitted to regulatory agencies in the US is known as a USDMF. Argatroban USDMF includes data on Argatroban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Argatroban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Argatroban suppliers with USDMF on PharmaCompass.
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