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API SUPPLIERS
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USDMF
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 : 2023-05-19
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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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...
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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global 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...
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ABOUT THIS PAGE
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).
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