Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Aspen API
03 3TAPI Technology & API Services
04 2Merck & Co
05 1Perrigo Company plc
06 1Plantex Ltd.
07 1Wyeth Pharmaceuticals Inc
08 2XINJIANG NUZILINE BIO PHARMACEUTICAL CO LTD
09 2Blank
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27920
Submission : 2014-02-19
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34883
Submission : 2020-06-09
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 : 2767
Submission : 1976-11-02
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 : 15915
Submission : 2002-03-28
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 13962
Submission : 1999-01-29
Status :
Type : II
A Premarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Premarin, including repackagers and relabelers. The FDA regulates Premarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Premarin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Premarin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Premarin supplier is an individual or a company that provides Premarin active pharmaceutical ingredient (API) or Premarin finished formulations upon request. The Premarin suppliers may include Premarin API manufacturers, exporters, distributors and traders.
click here to find a list of Premarin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Premarin DMF (Drug Master File) is a document detailing the whole manufacturing process of Premarin active pharmaceutical ingredient (API) in detail. Different forms of Premarin DMFs exist exist since differing nations have different regulations, such as Premarin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Premarin DMF submitted to regulatory agencies in the US is known as a USDMF. Premarin USDMF includes data on Premarin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Premarin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Premarin suppliers with USDMF on PharmaCompass.
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