Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Actavis Inc
03 1Cipla
04 1Jiangsu Joyglory Pharmaceutical
05 1MSN Laboratories
06 1Megafine Pharma (P) Limited
07 1Sun Pharmaceutical Industries Limited
08 1Tianjin Weijie Pharmaceutical Co., Ltd.
09 1Viatris
10 1Zhejiang Huahai Pharmaceutical
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-18
Pay. Date : 2014-11-19
DMF Number : 28781
Submission : 2014-11-18
Status :
Type : II
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PharmaCompass offers a list of Ambrisentan API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ambrisentan manufacturer or Ambrisentan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ambrisentan manufacturer or Ambrisentan supplier.
PharmaCompass also assists you with knowing the Ambrisentan API Price utilized in the formulation of products. Ambrisentan API Price is not always fixed or binding as the Ambrisentan Price is obtained through a variety of data sources. The Ambrisentan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ambrisentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambrisentan, including repackagers and relabelers. The FDA regulates Ambrisentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambrisentan 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 Ambrisentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambrisentan supplier is an individual or a company that provides Ambrisentan active pharmaceutical ingredient (API) or Ambrisentan finished formulations upon request. The Ambrisentan suppliers may include Ambrisentan API manufacturers, exporters, distributors and traders.
click here to find a list of Ambrisentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ambrisentan DMF (Drug Master File) is a document detailing the whole manufacturing process of Ambrisentan active pharmaceutical ingredient (API) in detail. Different forms of Ambrisentan DMFs exist exist since differing nations have different regulations, such as Ambrisentan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ambrisentan DMF submitted to regulatory agencies in the US is known as a USDMF. Ambrisentan USDMF includes data on Ambrisentan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ambrisentan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ambrisentan suppliers with USDMF on PharmaCompass.
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