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