Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Sanofi
03 1Aspen API
04 13M Drug Delivery Systems
05 1Bayer AG
06 1Cygnus Inc
07 3Gedeon Richter
08 1Industriale Chimica
09 1Lupin Ltd
10 1Merck & Co
11 1Pfizer Inc
12 1Blank
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-20
Pay. Date : 2020-03-24
DMF Number : 26020
Submission : 2012-05-02
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 : 2425
Submission : 1975-03-27
Status :
Type : II
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-04
Pay. Date : 2012-11-14
DMF Number : 3803
Submission : 1980-05-20
Status :
Type : II
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A ORTHO CYCLEN-28 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ORTHO CYCLEN-28, including repackagers and relabelers. The FDA regulates ORTHO CYCLEN-28 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ORTHO CYCLEN-28 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 ORTHO CYCLEN-28 supplier is an individual or a company that provides ORTHO CYCLEN-28 active pharmaceutical ingredient (API) or ORTHO CYCLEN-28 finished formulations upon request. The ORTHO CYCLEN-28 suppliers may include ORTHO CYCLEN-28 API manufacturers, exporters, distributors and traders.
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A ORTHO CYCLEN-28 DMF (Drug Master File) is a document detailing the whole manufacturing process of ORTHO CYCLEN-28 active pharmaceutical ingredient (API) in detail. Different forms of ORTHO CYCLEN-28 DMFs exist exist since differing nations have different regulations, such as ORTHO CYCLEN-28 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ORTHO CYCLEN-28 DMF submitted to regulatory agencies in the US is known as a USDMF. ORTHO CYCLEN-28 USDMF includes data on ORTHO CYCLEN-28's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ORTHO CYCLEN-28 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 11 companies offering ORTHO CYCLEN-28
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