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JDMF
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VMF
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API SUPPLIERS
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Click Us!
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
EU-WC
NDC
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
NDC
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC
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USDMF
HRV Pharma - 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 : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
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
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HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
About the Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and new modalities such as...
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ABOUT THIS PAGE
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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 (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.
A Pitolisant (hydrochloride) written confirmation (Pitolisant (hydrochloride) WC) is an official document issued by a regulatory agency to a Pitolisant (hydrochloride) manufacturer, verifying that the manufacturing facility of a Pitolisant (hydrochloride) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pitolisant (hydrochloride) APIs or Pitolisant (hydrochloride) finished pharmaceutical products to another nation, regulatory agencies frequently require a Pitolisant (hydrochloride) WC (written confirmation) as part of the regulatory process.
click here to find a list of Pitolisant (hydrochloride) suppliers with Written Confirmation (WC) 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 (hydrochloride) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pitolisant (hydrochloride) 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 (hydrochloride) 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 (hydrochloride) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pitolisant (hydrochloride) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pitolisant (hydrochloride) suppliers with NDC on PharmaCompass.
Pitolisant (hydrochloride) Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Pitolisant (hydrochloride) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pitolisant (hydrochloride) GMP manufacturer or Pitolisant (hydrochloride) GMP API supplier for your needs.
A Pitolisant (hydrochloride) CoA (Certificate of Analysis) is a formal document that attests to Pitolisant (hydrochloride)'s compliance with Pitolisant (hydrochloride) specifications and serves as a tool for batch-level quality control.
Pitolisant (hydrochloride) CoA mostly includes findings from lab analyses of a specific batch. For each Pitolisant (hydrochloride) CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Pitolisant (hydrochloride) may be tested according to a variety of international standards, such as European Pharmacopoeia (Pitolisant (hydrochloride) EP), Pitolisant (hydrochloride) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pitolisant (hydrochloride) USP).
