Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 2Axplora
03 1Sanofi
04 3TAPI Technology & API Services
05 1ACS DOBFAR SPA
06 1ALP Pharm
07 1Amphastar Pharmaceuticals
08 2Cipla
09 1Henan Lihua Pharmaceutical
10 3Hovione
11 1Mahima Life Sciences
12 1Quimica Sintetica
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28137
Submission : 2014-03-20
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-25
Pay. Date : 2019-04-22
DMF Number : 12813
Submission : 1998-01-05
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8036
Submission : 1989-04-28
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 : 2019-01-31
Pay. Date : 2019-01-28
DMF Number : 4871
Submission : 1983-03-14
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21972
Submission : 2008-09-11
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 16934
Submission : 2003-10-20
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 13965
Submission : 1999-01-29
Status :
Type : II
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A orBec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of orBec, including repackagers and relabelers. The FDA regulates orBec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. orBec 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 orBec supplier is an individual or a company that provides orBec active pharmaceutical ingredient (API) or orBec finished formulations upon request. The orBec suppliers may include orBec API manufacturers, exporters, distributors and traders.
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A orBec DMF (Drug Master File) is a document detailing the whole manufacturing process of orBec active pharmaceutical ingredient (API) in detail. Different forms of orBec DMFs exist exist since differing nations have different regulations, such as orBec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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