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API SUPPLIERS
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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
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-23
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No. 34B, 40B & 60B, J.N Pharma City, Thanam (V), Parawada (M), Ana...
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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PharmaCompass offers a list of Prucalopride Succinate 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 Prucalopride Succinate manufacturer or Prucalopride Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prucalopride Succinate manufacturer or Prucalopride Succinate supplier.
PharmaCompass also assists you with knowing the Prucalopride Succinate API Price utilized in the formulation of products. Prucalopride Succinate API Price is not always fixed or binding as the Prucalopride Succinate Price is obtained through a variety of data sources. The Prucalopride Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prucalopride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prucalopride, including repackagers and relabelers. The FDA regulates Prucalopride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prucalopride 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prucalopride supplier is an individual or a company that provides Prucalopride active pharmaceutical ingredient (API) or Prucalopride finished formulations upon request. The Prucalopride suppliers may include Prucalopride API manufacturers, exporters, distributors and traders.
click here to find a list of Prucalopride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prucalopride DMF (Drug Master File) is a document detailing the whole manufacturing process of Prucalopride active pharmaceutical ingredient (API) in detail. Different forms of Prucalopride DMFs exist exist since differing nations have different regulations, such as Prucalopride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prucalopride DMF submitted to regulatory agencies in the US is known as a USDMF. Prucalopride USDMF includes data on Prucalopride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prucalopride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prucalopride 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 Drug Master File in Korea (Prucalopride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prucalopride. The MFDS reviews the Prucalopride KDMF as part of the drug registration process and uses the information provided in the Prucalopride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prucalopride 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prucalopride suppliers with KDMF on PharmaCompass.
A Prucalopride written confirmation (Prucalopride WC) is an official document issued by a regulatory agency to a Prucalopride manufacturer, verifying that the manufacturing facility of a Prucalopride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prucalopride APIs or Prucalopride finished pharmaceutical products to another nation, regulatory agencies frequently require a Prucalopride WC (written confirmation) as part of the regulatory process.
click here to find a list of Prucalopride 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prucalopride 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prucalopride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prucalopride suppliers with NDC on PharmaCompass.
Prucalopride 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 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 GMP manufacturer or Prucalopride GMP API supplier for your needs.
A Prucalopride CoA (Certificate of Analysis) is a formal document that attests to Prucalopride's compliance with Prucalopride specifications and serves as a tool for batch-level quality control.
Prucalopride CoA mostly includes findings from lab analyses of a specific batch. For each Prucalopride 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Prucalopride EP), Prucalopride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prucalopride USP).
