01 1Sandoz B2B
01 17-AMCA
01 1Switzerland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17683
Submission : 2004-09-10
Status : Active
Type : II
A 7-Amca manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 7-Amca, including repackagers and relabelers. The FDA regulates 7-Amca manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 7-Amca 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 7-Amca supplier is an individual or a company that provides 7-Amca active pharmaceutical ingredient (API) or 7-Amca finished formulations upon request. The 7-Amca suppliers may include 7-Amca API manufacturers, exporters, distributors and traders.
click here to find a list of 7-Amca suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 7-Amca DMF (Drug Master File) is a document detailing the whole manufacturing process of 7-Amca active pharmaceutical ingredient (API) in detail. Different forms of 7-Amca DMFs exist exist since differing nations have different regulations, such as 7-Amca USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 7-Amca DMF submitted to regulatory agencies in the US is known as a USDMF. 7-Amca USDMF includes data on 7-Amca's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 7-Amca USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 7-Amca suppliers with USDMF on PharmaCompass.
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