Chirogate is a professional Prostaglandin manufacturer.
01 3Chirogate International
02 1Nuray Chemicals Private Limited
03 1EUROAPI
04 1Dr. Reddy's Laboratories
05 1Alphora Research
06 1DMFs Not Supported
07 1Emcure Pharmaceuticals
08 2MSN Laboratories
09 1Mannkind
10 1Pfizer Inc
11 1Yonsung Fine Chemicals
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28340
Submission : 2016-08-15
Status :
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-16
Pay. Date : 2016-09-20
DMF Number : 30861
Submission : 2016-09-27
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2016-11-25
DMF Number : 31145
Submission : 2016-12-09
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-06-10
DMF Number : 30106
Submission : 2016-01-12
Status :
Type : II
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29207
Submission : 2015-08-12
Status :
Type : II
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-07-15
DMF Number : 28458
Submission : 2014-09-16
Status :
Type : II
A Remodulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remodulin, including repackagers and relabelers. The FDA regulates Remodulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remodulin 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 Remodulin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Remodulin supplier is an individual or a company that provides Remodulin active pharmaceutical ingredient (API) or Remodulin finished formulations upon request. The Remodulin suppliers may include Remodulin API manufacturers, exporters, distributors and traders.
click here to find a list of Remodulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Remodulin DMF (Drug Master File) is a document detailing the whole manufacturing process of Remodulin active pharmaceutical ingredient (API) in detail. Different forms of Remodulin DMFs exist exist since differing nations have different regulations, such as Remodulin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Remodulin DMF submitted to regulatory agencies in the US is known as a USDMF. Remodulin USDMF includes data on Remodulin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Remodulin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Remodulin suppliers with USDMF on PharmaCompass.
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