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 is your 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 Anaprime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anaprime, including repackagers and relabelers. The FDA regulates Anaprime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anaprime 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 Anaprime supplier is an individual or a company that provides Anaprime active pharmaceutical ingredient (API) or Anaprime finished formulations upon request. The Anaprime suppliers may include Anaprime API manufacturers, exporters, distributors and traders.
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A Anaprime DMF (Drug Master File) is a document detailing the whole manufacturing process of Anaprime active pharmaceutical ingredient (API) in detail. Different forms of Anaprime DMFs exist exist since differing nations have different regulations, such as Anaprime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anaprime DMF submitted to regulatory agencies in the US is known as a USDMF. Anaprime USDMF includes data on Anaprime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anaprime USDMF is kept confidential to protect the manufacturer’s intellectual property.
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