Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 2NURAY CHEMICALS PRIVATE LIMITED
02 1Biophore India Pharmaceuticals Pvt. Ltd
03 1Dasami Lab Private Limited
04 1MSN Laboratories Private Limited
01 1PITOLISANT HYDROCHLORIDE
02 1Pitolisant
03 2Pitolisant Hydrochloride
04 1Pitolisant Hydrochloride SD
01 5India
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
NDC Package Code : 73435-034
Start Marketing Date : 2023-12-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-092
Start Marketing Date : 2022-09-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70966-0038
Start Marketing Date : 2019-08-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14501-0114
Start Marketing Date : 2023-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pitolisant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pitolisant API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Pitolisant as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Pitolisant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pitolisant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pitolisant suppliers with NDC on PharmaCompass.
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