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API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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USDMF
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Drugs in Development
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21999
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21999
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 3MG
USFDA APPLICATION NUMBER - 21999
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 6MG
USFDA APPLICATION NUMBER - 21999
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 9MG
USFDA APPLICATION NUMBER - 21999
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
ABOUT THIS PAGE
A Paliperidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paliperidone, including repackagers and relabelers. The FDA regulates Paliperidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paliperidone 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 Paliperidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paliperidone supplier is an individual or a company that provides Paliperidone active pharmaceutical ingredient (API) or Paliperidone finished formulations upon request. The Paliperidone suppliers may include Paliperidone API manufacturers, exporters, distributors and traders.
click here to find a list of Paliperidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paliperidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Paliperidone active pharmaceutical ingredient (API) in detail. Different forms of Paliperidone DMFs exist exist since differing nations have different regulations, such as Paliperidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paliperidone DMF submitted to regulatory agencies in the US is known as a USDMF. Paliperidone USDMF includes data on Paliperidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paliperidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paliperidone 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 Paliperidone Drug Master File in Korea (Paliperidone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Paliperidone. The MFDS reviews the Paliperidone KDMF as part of the drug registration process and uses the information provided in the Paliperidone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Paliperidone 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 Paliperidone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Paliperidone suppliers with KDMF on PharmaCompass.
A Paliperidone written confirmation (Paliperidone WC) is an official document issued by a regulatory agency to a Paliperidone manufacturer, verifying that the manufacturing facility of a Paliperidone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Paliperidone APIs or Paliperidone finished pharmaceutical products to another nation, regulatory agencies frequently require a Paliperidone WC (written confirmation) as part of the regulatory process.
click here to find a list of Paliperidone 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 Paliperidone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Paliperidone 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 Paliperidone 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 Paliperidone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Paliperidone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Paliperidone suppliers with NDC on PharmaCompass.
Paliperidone 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 Paliperidone 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 Paliperidone GMP manufacturer or Paliperidone GMP API supplier for your needs.
A Paliperidone CoA (Certificate of Analysis) is a formal document that attests to Paliperidone's compliance with Paliperidone specifications and serves as a tool for batch-level quality control.
Paliperidone CoA mostly includes findings from lab analyses of a specific batch. For each Paliperidone 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.
Paliperidone may be tested according to a variety of international standards, such as European Pharmacopoeia (Paliperidone EP), Paliperidone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Paliperidone USP).
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