Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Honour Lab Limited
03 1Curia
04 1ORGANICA Feinchemie GmbH Wolfen
05 1Vasudha Pharma Chem
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-05
Pay. Date : 2015-04-08
DMF Number : 28740
Submission : 2014-10-31
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-24
Pay. Date : 2020-01-09
DMF Number : 34403
Submission : 2020-04-09
Status :
Type : II
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27165
Submission : 2013-05-22
Status :
Type : II
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A Cystographin Dilute manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cystographin Dilute, including repackagers and relabelers. The FDA regulates Cystographin Dilute manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cystographin Dilute 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 Cystographin Dilute supplier is an individual or a company that provides Cystographin Dilute active pharmaceutical ingredient (API) or Cystographin Dilute finished formulations upon request. The Cystographin Dilute suppliers may include Cystographin Dilute API manufacturers, exporters, distributors and traders.
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A Cystographin Dilute DMF (Drug Master File) is a document detailing the whole manufacturing process of Cystographin Dilute active pharmaceutical ingredient (API) in detail. Different forms of Cystographin Dilute DMFs exist exist since differing nations have different regulations, such as Cystographin Dilute USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cystographin Dilute DMF submitted to regulatory agencies in the US is known as a USDMF. Cystographin Dilute USDMF includes data on Cystographin Dilute's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cystographin Dilute USDMF is kept confidential to protect the manufacturer’s intellectual property.
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