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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
EU-WC
NDC
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
EU-WC
NDC
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
NDC
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-28
DMF Number : 37576
Submission : 2022-10-31
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-06
Pay. Date : 2022-09-19
DMF Number : 34970
Submission : 2020-08-21
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 : 2023-04-04
Pay. Date : 2023-04-17
DMF Number : 36765
Submission : 2022-02-18
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-03
Pay. Date : 2022-06-13
DMF Number : 37181
Submission : 2022-06-13
Status :
Type : II
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ABOUT THIS PAGE
A Prucalopride Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prucalopride Succinate, including repackagers and relabelers. The FDA regulates Prucalopride Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prucalopride Succinate 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 Prucalopride Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prucalopride Succinate supplier is an individual or a company that provides Prucalopride Succinate active pharmaceutical ingredient (API) or Prucalopride Succinate finished formulations upon request. The Prucalopride Succinate suppliers may include Prucalopride Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Prucalopride Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prucalopride Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prucalopride Succinate active pharmaceutical ingredient (API) in detail. Different forms of Prucalopride Succinate DMFs exist exist since differing nations have different regulations, such as Prucalopride Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prucalopride Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Prucalopride Succinate USDMF includes data on Prucalopride Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prucalopride Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prucalopride Succinate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Prucalopride Succinate Drug Master File in Korea (Prucalopride Succinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prucalopride Succinate. The MFDS reviews the Prucalopride Succinate KDMF as part of the drug registration process and uses the information provided in the Prucalopride Succinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prucalopride Succinate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Prucalopride Succinate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prucalopride Succinate suppliers with KDMF on PharmaCompass.
A Prucalopride Succinate written confirmation (Prucalopride Succinate WC) is an official document issued by a regulatory agency to a Prucalopride Succinate manufacturer, verifying that the manufacturing facility of a Prucalopride Succinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prucalopride Succinate APIs or Prucalopride Succinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Prucalopride Succinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Prucalopride Succinate 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 Prucalopride Succinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prucalopride Succinate 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 Prucalopride Succinate 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 Prucalopride Succinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prucalopride Succinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prucalopride Succinate suppliers with NDC on PharmaCompass.
Prucalopride Succinate 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 Prucalopride Succinate 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 Prucalopride Succinate GMP manufacturer or Prucalopride Succinate GMP API supplier for your needs.
A Prucalopride Succinate CoA (Certificate of Analysis) is a formal document that attests to Prucalopride Succinate's compliance with Prucalopride Succinate specifications and serves as a tool for batch-level quality control.
Prucalopride Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Prucalopride Succinate 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.
Prucalopride Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prucalopride Succinate EP), Prucalopride Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prucalopride Succinate USP).
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