01 1SP QUIMICA, S.A.
01 1BENSERAZIDE HYDROCHLORIDE
01 1Spain
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36473
Submission : 2022-06-03
Status : Active
Type : II
73
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A Pharmakon1600-01500137 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pharmakon1600-01500137, including repackagers and relabelers. The FDA regulates Pharmakon1600-01500137 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pharmakon1600-01500137 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Pharmakon1600-01500137 supplier is an individual or a company that provides Pharmakon1600-01500137 active pharmaceutical ingredient (API) or Pharmakon1600-01500137 finished formulations upon request. The Pharmakon1600-01500137 suppliers may include Pharmakon1600-01500137 API manufacturers, exporters, distributors and traders.
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A Pharmakon1600-01500137 DMF (Drug Master File) is a document detailing the whole manufacturing process of Pharmakon1600-01500137 active pharmaceutical ingredient (API) in detail. Different forms of Pharmakon1600-01500137 DMFs exist exist since differing nations have different regulations, such as Pharmakon1600-01500137 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pharmakon1600-01500137 DMF submitted to regulatory agencies in the US is known as a USDMF. Pharmakon1600-01500137 USDMF includes data on Pharmakon1600-01500137's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pharmakon1600-01500137 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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