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
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PharmaCompass offers a list of Pitolisant Hydrochloride 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 Pitolisant Hydrochloride manufacturer or Pitolisant Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pitolisant Hydrochloride manufacturer or Pitolisant Hydrochloride supplier.
PharmaCompass also assists you with knowing the Pitolisant Hydrochloride API Price utilized in the formulation of products. Pitolisant Hydrochloride API Price is not always fixed or binding as the Pitolisant Hydrochloride Price is obtained through a variety of data sources. The Pitolisant Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pitolisant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pitolisant, including repackagers and relabelers. The FDA regulates Pitolisant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pitolisant 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pitolisant supplier is an individual or a company that provides Pitolisant active pharmaceutical ingredient (API) or Pitolisant finished formulations upon request. The Pitolisant suppliers may include Pitolisant API manufacturers, exporters, distributors and traders.
click here to find a list of Pitolisant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pitolisant DMF (Drug Master File) is a document detailing the whole manufacturing process of Pitolisant active pharmaceutical ingredient (API) in detail. Different forms of Pitolisant DMFs exist exist since differing nations have different regulations, such as Pitolisant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pitolisant DMF submitted to regulatory agencies in the US is known as a USDMF. Pitolisant USDMF includes data on Pitolisant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pitolisant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pitolisant suppliers with USDMF on PharmaCompass.
We have 6 companies offering Pitolisant
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