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CEP/COS
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JDMF
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VMF
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Click Us!
Trusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.
ASMF
Axplora is your partner of choice for complex APIs.
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
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
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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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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DATA COMPILATION #PharmaFlow
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
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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 179474-85-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 179474-85-2, including repackagers and relabelers. The FDA regulates 179474-85-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 179474-85-2 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 179474-85-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 179474-85-2 supplier is an individual or a company that provides 179474-85-2 active pharmaceutical ingredient (API) or 179474-85-2 finished formulations upon request. The 179474-85-2 suppliers may include 179474-85-2 API manufacturers, exporters, distributors and traders.
click here to find a list of 179474-85-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 179474-85-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of 179474-85-2 active pharmaceutical ingredient (API) in detail. Different forms of 179474-85-2 DMFs exist exist since differing nations have different regulations, such as 179474-85-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 179474-85-2 DMF submitted to regulatory agencies in the US is known as a USDMF. 179474-85-2 USDMF includes data on 179474-85-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 179474-85-2 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 179474-85-2 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 179474-85-2 Drug Master File in Korea (179474-85-2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 179474-85-2. The MFDS reviews the 179474-85-2 KDMF as part of the drug registration process and uses the information provided in the 179474-85-2 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 179474-85-2 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 179474-85-2 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 179474-85-2 suppliers with KDMF on PharmaCompass.
A 179474-85-2 written confirmation (179474-85-2 WC) is an official document issued by a regulatory agency to a 179474-85-2 manufacturer, verifying that the manufacturing facility of a 179474-85-2 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 179474-85-2 APIs or 179474-85-2 finished pharmaceutical products to another nation, regulatory agencies frequently require a 179474-85-2 WC (written confirmation) as part of the regulatory process.
click here to find a list of 179474-85-2 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 179474-85-2 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 179474-85-2 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 179474-85-2 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 179474-85-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 179474-85-2 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 179474-85-2 suppliers with NDC on PharmaCompass.
179474-85-2 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 179474-85-2 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 179474-85-2 GMP manufacturer or 179474-85-2 GMP API supplier for your needs.
A 179474-85-2 CoA (Certificate of Analysis) is a formal document that attests to 179474-85-2's compliance with 179474-85-2 specifications and serves as a tool for batch-level quality control.
179474-85-2 CoA mostly includes findings from lab analyses of a specific batch. For each 179474-85-2 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.
179474-85-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (179474-85-2 EP), 179474-85-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (179474-85-2 USP).
