PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC Isochem
01 1AMINOPYRROLAMIDE
01 1France
01 1Active
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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12992
Submission : 1998-05-15
Status : Active
Type : II
A 1-Pyrrolidinamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-Pyrrolidinamine, including repackagers and relabelers. The FDA regulates 1-Pyrrolidinamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-Pyrrolidinamine 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 1-Pyrrolidinamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1-Pyrrolidinamine supplier is an individual or a company that provides 1-Pyrrolidinamine active pharmaceutical ingredient (API) or 1-Pyrrolidinamine finished formulations upon request. The 1-Pyrrolidinamine suppliers may include 1-Pyrrolidinamine API manufacturers, exporters, distributors and traders.
click here to find a list of 1-Pyrrolidinamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1-Pyrrolidinamine DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-Pyrrolidinamine active pharmaceutical ingredient (API) in detail. Different forms of 1-Pyrrolidinamine DMFs exist exist since differing nations have different regulations, such as 1-Pyrrolidinamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-Pyrrolidinamine DMF submitted to regulatory agencies in the US is known as a USDMF. 1-Pyrrolidinamine USDMF includes data on 1-Pyrrolidinamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-Pyrrolidinamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1-Pyrrolidinamine suppliers with USDMF on PharmaCompass.
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