Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1USV Private Limited
04 1Curia
05 2GLAND PHARMA LIMITED
06 1MSN Laboratories
07 1Nanjing Heron Pharmaceutical
08 1ScinoPharm Taiwan, Ltd
09 1Sun Pharmaceutical Industries Limited
10 1Viatris
11 1Wockhardt
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-18
Pay. Date : 2021-01-13
DMF Number : 35433
Submission : 2021-01-04
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-08
Pay. Date : 2016-09-16
DMF Number : 30834
Submission : 2016-09-13
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-24
Pay. Date : 2015-06-24
DMF Number : 29315
Submission : 2015-06-23
Status :
Type : II
A Regadenoson manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regadenoson, including repackagers and relabelers. The FDA regulates Regadenoson manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regadenoson 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 Regadenoson manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Regadenoson supplier is an individual or a company that provides Regadenoson active pharmaceutical ingredient (API) or Regadenoson finished formulations upon request. The Regadenoson suppliers may include Regadenoson API manufacturers, exporters, distributors and traders.
click here to find a list of Regadenoson suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Regadenoson DMF (Drug Master File) is a document detailing the whole manufacturing process of Regadenoson active pharmaceutical ingredient (API) in detail. Different forms of Regadenoson DMFs exist exist since differing nations have different regulations, such as Regadenoson USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Regadenoson DMF submitted to regulatory agencies in the US is known as a USDMF. Regadenoson USDMF includes data on Regadenoson's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Regadenoson USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Regadenoson suppliers with USDMF on PharmaCompass.
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