01 1Productos Quimicos Naturales
01 1EQUILIN, USP
01 1Mexico
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13972
Submission : 1999-02-09
Status : Inactive
Type : II
A Equilin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Equilin, including repackagers and relabelers. The FDA regulates Equilin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Equilin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Equilin supplier is an individual or a company that provides Equilin active pharmaceutical ingredient (API) or Equilin finished formulations upon request. The Equilin suppliers may include Equilin API manufacturers, exporters, distributors and traders.
click here to find a list of Equilin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Equilin DMF (Drug Master File) is a document detailing the whole manufacturing process of Equilin active pharmaceutical ingredient (API) in detail. Different forms of Equilin DMFs exist exist since differing nations have different regulations, such as Equilin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Equilin DMF submitted to regulatory agencies in the US is known as a USDMF. Equilin USDMF includes data on Equilin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Equilin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Equilin suppliers with USDMF on PharmaCompass.
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