Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1TAPI Technology & API Services
03 1Bayer AG
04 1Gedeon Richter
05 1Industriale Chimica
06 1Lupin Ltd
07 2NEWCHEM SPA
08 1Sterling Spa
09 1Sun Pharmaceutical Industries Limited
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32885
Submission : 2018-08-30
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 22878
Submission : 2009-06-18
Status :
Type : II
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PharmaCompass offers a list of Drospirenone 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 Drospirenone manufacturer or Drospirenone supplier for your needs.
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A Drospirenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Drospirenone, including repackagers and relabelers. The FDA regulates Drospirenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Drospirenone 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 Drospirenone supplier is an individual or a company that provides Drospirenone active pharmaceutical ingredient (API) or Drospirenone finished formulations upon request. The Drospirenone suppliers may include Drospirenone API manufacturers, exporters, distributors and traders.
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A Drospirenone DMF (Drug Master File) is a document detailing the whole manufacturing process of Drospirenone active pharmaceutical ingredient (API) in detail. Different forms of Drospirenone DMFs exist exist since differing nations have different regulations, such as Drospirenone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Drospirenone DMF submitted to regulatory agencies in the US is known as a USDMF. Drospirenone USDMF includes data on Drospirenone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Drospirenone USDMF is kept confidential to protect the manufacturer’s intellectual property.
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