01 1Abbott Laboratories
01 1SPECTINOMYCIN DIHDROCHLORIDE PENTAHYDRATE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4630
Submission : 1982-07-13
Status : Inactive
Type : II
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A Stanilo manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stanilo, including repackagers and relabelers. The FDA regulates Stanilo manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stanilo 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 Stanilo supplier is an individual or a company that provides Stanilo active pharmaceutical ingredient (API) or Stanilo finished formulations upon request. The Stanilo suppliers may include Stanilo API manufacturers, exporters, distributors and traders.
click here to find a list of Stanilo suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Stanilo DMF (Drug Master File) is a document detailing the whole manufacturing process of Stanilo active pharmaceutical ingredient (API) in detail. Different forms of Stanilo DMFs exist exist since differing nations have different regulations, such as Stanilo USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Stanilo DMF submitted to regulatory agencies in the US is known as a USDMF. Stanilo USDMF includes data on Stanilo's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Stanilo USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Stanilo suppliers with USDMF on PharmaCompass.
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