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A Paliperidone Palmitate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paliperidone Palmitate, including repackagers and relabelers. The FDA regulates Paliperidone Palmitate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paliperidone Palmitate 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 Palmitate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paliperidone Palmitate supplier is an individual or a company that provides Paliperidone Palmitate active pharmaceutical ingredient (API) or Paliperidone Palmitate finished formulations upon request. The Paliperidone Palmitate suppliers may include Paliperidone Palmitate API manufacturers, exporters, distributors and traders.
click here to find a list of Paliperidone Palmitate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paliperidone Palmitate DMF (Drug Master File) is a document detailing the whole manufacturing process of Paliperidone Palmitate active pharmaceutical ingredient (API) in detail. Different forms of Paliperidone Palmitate DMFs exist exist since differing nations have different regulations, such as Paliperidone Palmitate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paliperidone Palmitate DMF submitted to regulatory agencies in the US is known as a USDMF. Paliperidone Palmitate USDMF includes data on Paliperidone Palmitate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paliperidone Palmitate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paliperidone Palmitate 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 Palmitate Drug Master File in Korea (Paliperidone Palmitate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Paliperidone Palmitate. The MFDS reviews the Paliperidone Palmitate KDMF as part of the drug registration process and uses the information provided in the Paliperidone Palmitate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Paliperidone Palmitate 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 Palmitate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Paliperidone Palmitate suppliers with KDMF on PharmaCompass.
A Paliperidone Palmitate written confirmation (Paliperidone Palmitate WC) is an official document issued by a regulatory agency to a Paliperidone Palmitate manufacturer, verifying that the manufacturing facility of a Paliperidone Palmitate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Paliperidone Palmitate APIs or Paliperidone Palmitate finished pharmaceutical products to another nation, regulatory agencies frequently require a Paliperidone Palmitate WC (written confirmation) as part of the regulatory process.
click here to find a list of Paliperidone Palmitate 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 Palmitate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Paliperidone Palmitate 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 Palmitate 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 Palmitate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Paliperidone Palmitate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Paliperidone Palmitate suppliers with NDC on PharmaCompass.
Paliperidone Palmitate 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 Palmitate 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 Palmitate GMP manufacturer or Paliperidone Palmitate GMP API supplier for your needs.
A Paliperidone Palmitate CoA (Certificate of Analysis) is a formal document that attests to Paliperidone Palmitate's compliance with Paliperidone Palmitate specifications and serves as a tool for batch-level quality control.
Paliperidone Palmitate CoA mostly includes findings from lab analyses of a specific batch. For each Paliperidone Palmitate 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 Palmitate may be tested according to a variety of international standards, such as European Pharmacopoeia (Paliperidone Palmitate EP), Paliperidone Palmitate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Paliperidone Palmitate USP).
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