Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Axplora
03 1ACS DOBFAR SPA
04 2Aurisco Pharmaceutical
05 1Hovione
06 3Laboratorio Syntex S.A
07 1Pfizer Inc
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-17
Pay. Date : 2013-11-01
DMF Number : 25547
Submission : 2011-12-01
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15534
Submission : 2001-07-18
Status :
Type : II
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A CAS-2135-17-3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-2135-17-3, including repackagers and relabelers. The FDA regulates CAS-2135-17-3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-2135-17-3 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 CAS-2135-17-3 supplier is an individual or a company that provides CAS-2135-17-3 active pharmaceutical ingredient (API) or CAS-2135-17-3 finished formulations upon request. The CAS-2135-17-3 suppliers may include CAS-2135-17-3 API manufacturers, exporters, distributors and traders.
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A CAS-2135-17-3 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-2135-17-3 active pharmaceutical ingredient (API) in detail. Different forms of CAS-2135-17-3 DMFs exist exist since differing nations have different regulations, such as CAS-2135-17-3 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-2135-17-3 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-2135-17-3 USDMF includes data on CAS-2135-17-3's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-2135-17-3 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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