Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Jubilant Generics
03 1PharmaBlock Sciences
04 1Procos
05 1Quimica Sintetica
06 2Sandoz B2B
07 1Torrent Pharmaceuticals Limited
08 1Unichem Laboratories Limited
09 1Zhejiang Guobang Pharmaceutical
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-05
DMF Number : 8590
Submission : 1990-06-12
Status :
Type : II
A Guanfacine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guanfacine, including repackagers and relabelers. The FDA regulates Guanfacine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guanfacine 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 Guanfacine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Guanfacine supplier is an individual or a company that provides Guanfacine active pharmaceutical ingredient (API) or Guanfacine finished formulations upon request. The Guanfacine suppliers may include Guanfacine API manufacturers, exporters, distributors and traders.
click here to find a list of Guanfacine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Guanfacine DMF (Drug Master File) is a document detailing the whole manufacturing process of Guanfacine active pharmaceutical ingredient (API) in detail. Different forms of Guanfacine DMFs exist exist since differing nations have different regulations, such as Guanfacine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Guanfacine DMF submitted to regulatory agencies in the US is known as a USDMF. Guanfacine USDMF includes data on Guanfacine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Guanfacine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Guanfacine suppliers with USDMF on PharmaCompass.
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