Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Axplora
03 1Sanofi
04 1ACS DOBFAR SPA
05 1Bayer AG
06 1Curia
07 1Fujifilm Diosynth Biotechnologies
08 1Hikma Pharmaceuticals
09 1Laboratorio Syntex S.A
10 1Pfizer Inc
11 1SIMS Srl
12 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24611
Submission : 2011-02-03
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-12-31
DMF Number : 27325
Submission : 2013-07-19
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 : 3452
Submission : 1979-02-08
Status :
Type : II
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A Methylprednisolone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylprednisolone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Methylprednisolone Acetate DMFs exist exist since differing nations have different regulations, such as Methylprednisolone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylprednisolone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Methylprednisolone Acetate USDMF includes data on Methylprednisolone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylprednisolone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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