HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 2Nuray Chemicals Private Limited
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Dasami Lab
05 1Emnar Pharma
06 1MSN Laboratories
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39721
Submission : 2024-04-01
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 : 2023-03-31
Pay. Date : 2023-03-15
DMF Number : 36859
Submission : 2022-03-01
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-28
Pay. Date : 2023-07-06
DMF Number : 37753
Submission : 2022-12-31
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 : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
Status :
Type : II
A Pitolisant (hydrochloride) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pitolisant (hydrochloride), including repackagers and relabelers. The FDA regulates Pitolisant (hydrochloride) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pitolisant (hydrochloride) 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 Pitolisant (hydrochloride) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pitolisant (hydrochloride) supplier is an individual or a company that provides Pitolisant (hydrochloride) active pharmaceutical ingredient (API) or Pitolisant (hydrochloride) finished formulations upon request. The Pitolisant (hydrochloride) suppliers may include Pitolisant (hydrochloride) API manufacturers, exporters, distributors and traders.
click here to find a list of Pitolisant (hydrochloride) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pitolisant (hydrochloride) DMF (Drug Master File) is a document detailing the whole manufacturing process of Pitolisant (hydrochloride) active pharmaceutical ingredient (API) in detail. Different forms of Pitolisant (hydrochloride) DMFs exist exist since differing nations have different regulations, such as Pitolisant (hydrochloride) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pitolisant (hydrochloride) DMF submitted to regulatory agencies in the US is known as a USDMF. Pitolisant (hydrochloride) USDMF includes data on Pitolisant (hydrochloride)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pitolisant (hydrochloride) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pitolisant (hydrochloride) suppliers with USDMF on PharmaCompass.
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