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
01 1PITOLISANT
02 2PITOLISANT HYDROCHLORIDE
03 1PITOLISANT HYDROCHLORIDE IN-HOUSE
04 1PITOLISANT HYDROCHLORIDE SD
05 1PITOLISANT HYDROCHLORIDE SOLID DISPERSION
06 1Pitolisant Hydrochloride
01 7India
01 7Active
01 6Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39721
Submission : 2024-04-01
Status : Active
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 : Active
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 : Active
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 : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-17
Pay. Date : 2023-04-25
DMF Number : 38131
Submission : 2023-03-27
Status : Active
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.
We have 6 companies offering Pitolisant Hydrochloride
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