Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
01 1Siegfried AG
02 1Cadila Pharmaceuticals
03 1Cyalume Specialty Products
04 1Mallinckrodt Pharmaceuticals
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-05
Pay. Date : 2013-01-24
DMF Number : 4185
Submission : 1981-05-27
Status :
Type : II
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PharmaCompass offers a list of Pseudoephedrine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Pseudoephedrine manufacturer or Pseudoephedrine supplier for your needs.
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A Pseudoephedrine polistirex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pseudoephedrine polistirex, including repackagers and relabelers. The FDA regulates Pseudoephedrine polistirex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pseudoephedrine polistirex 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 Pseudoephedrine polistirex supplier is an individual or a company that provides Pseudoephedrine polistirex active pharmaceutical ingredient (API) or Pseudoephedrine polistirex finished formulations upon request. The Pseudoephedrine polistirex suppliers may include Pseudoephedrine polistirex API manufacturers, exporters, distributors and traders.
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A Pseudoephedrine polistirex DMF (Drug Master File) is a document detailing the whole manufacturing process of Pseudoephedrine polistirex active pharmaceutical ingredient (API) in detail. Different forms of Pseudoephedrine polistirex DMFs exist exist since differing nations have different regulations, such as Pseudoephedrine polistirex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pseudoephedrine polistirex DMF submitted to regulatory agencies in the US is known as a USDMF. Pseudoephedrine polistirex USDMF includes data on Pseudoephedrine polistirex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pseudoephedrine polistirex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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