Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Nuray Chemicals Private Limited
03 1TAPI Technology & API Services
04 1Dipharma SA
05 1Saurav Chemicals
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-28
Pay. Date : 2020-08-06
DMF Number : 33948
Submission : 2019-07-17
Status :
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-12-26
DMF Number : 31250
Submission : 2017-01-02
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 : 30680
Submission : 2016-10-19
Status :
Type : II
A Nitisinone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitisinone, including repackagers and relabelers. The FDA regulates Nitisinone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitisinone 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 Nitisinone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitisinone supplier is an individual or a company that provides Nitisinone active pharmaceutical ingredient (API) or Nitisinone finished formulations upon request. The Nitisinone suppliers may include Nitisinone API manufacturers, exporters, distributors and traders.
click here to find a list of Nitisinone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitisinone DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitisinone active pharmaceutical ingredient (API) in detail. Different forms of Nitisinone DMFs exist exist since differing nations have different regulations, such as Nitisinone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitisinone DMF submitted to regulatory agencies in the US is known as a USDMF. Nitisinone USDMF includes data on Nitisinone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitisinone USDMF is kept confidential to protect the manufacturer’s intellectual property.
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