01 1GSK
01 1APSAC (ANISOYLATED PLASMINOGEN STREPTOKINASE COMPLEX - BRL26921)
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27158
Submission : 1987-05-22
Status : Inactive
Type : II
A Streptokinase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Streptokinase, including repackagers and relabelers. The FDA regulates Streptokinase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Streptokinase 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 Streptokinase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Streptokinase supplier is an individual or a company that provides Streptokinase active pharmaceutical ingredient (API) or Streptokinase finished formulations upon request. The Streptokinase suppliers may include Streptokinase API manufacturers, exporters, distributors and traders.
click here to find a list of Streptokinase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Streptokinase DMF (Drug Master File) is a document detailing the whole manufacturing process of Streptokinase active pharmaceutical ingredient (API) in detail. Different forms of Streptokinase DMFs exist exist since differing nations have different regulations, such as Streptokinase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Streptokinase DMF submitted to regulatory agencies in the US is known as a USDMF. Streptokinase USDMF includes data on Streptokinase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Streptokinase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Streptokinase suppliers with USDMF on PharmaCompass.
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