ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Farmhispania
03 1Boehringer Ingelheim GmbH
04 1Emcure Pharmaceuticals
05 1Evotec
06 1Grace
07 1Hikma Pharmaceuticals
08 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
09 1Lunan Pharmaceutical
10 1Sai Life Sciences Limited
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-13
DMF Number : 13195
Submission : 1998-09-23
Status :
Type : II
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14319
Submission : 1999-07-01
Status :
Type : II
A Milrinone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Milrinone, including repackagers and relabelers. The FDA regulates Milrinone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Milrinone 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 Milrinone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Milrinone supplier is an individual or a company that provides Milrinone active pharmaceutical ingredient (API) or Milrinone finished formulations upon request. The Milrinone suppliers may include Milrinone API manufacturers, exporters, distributors and traders.
click here to find a list of Milrinone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Milrinone DMF (Drug Master File) is a document detailing the whole manufacturing process of Milrinone active pharmaceutical ingredient (API) in detail. Different forms of Milrinone DMFs exist exist since differing nations have different regulations, such as Milrinone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Milrinone DMF submitted to regulatory agencies in the US is known as a USDMF. Milrinone USDMF includes data on Milrinone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Milrinone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Milrinone suppliers with USDMF on PharmaCompass.
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