01 1Abbott Laboratories
01 1SPECTINOMYCIN (M-141, ABBOTT) (VET)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 628
Submission : 1963-08-08
Status : Inactive
Type : II
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A SPCM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SPCM, including repackagers and relabelers. The FDA regulates SPCM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SPCM 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 SPCM manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A SPCM supplier is an individual or a company that provides SPCM active pharmaceutical ingredient (API) or SPCM finished formulations upon request. The SPCM suppliers may include SPCM API manufacturers, exporters, distributors and traders.
click here to find a list of SPCM suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A SPCM DMF (Drug Master File) is a document detailing the whole manufacturing process of SPCM active pharmaceutical ingredient (API) in detail. Different forms of SPCM DMFs exist exist since differing nations have different regulations, such as SPCM USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SPCM DMF submitted to regulatory agencies in the US is known as a USDMF. SPCM USDMF includes data on SPCM's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SPCM USDMF is kept confidential to protect the manufacturer’s intellectual property.
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