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ABOUT THIS PAGE
A Retapamulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Retapamulin, including repackagers and relabelers. The FDA regulates Retapamulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Retapamulin 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 Retapamulin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Retapamulin supplier is an individual or a company that provides Retapamulin active pharmaceutical ingredient (API) or Retapamulin finished formulations upon request. The Retapamulin suppliers may include Retapamulin API manufacturers, exporters, distributors and traders.
click here to find a list of Retapamulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Retapamulin Drug Master File in Korea (Retapamulin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Retapamulin. The MFDS reviews the Retapamulin KDMF as part of the drug registration process and uses the information provided in the Retapamulin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Retapamulin 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 Retapamulin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Retapamulin suppliers with KDMF 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 Retapamulin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Retapamulin 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 Retapamulin 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 Retapamulin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Retapamulin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Retapamulin suppliers with NDC on PharmaCompass.
Retapamulin 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 Retapamulin 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 Retapamulin GMP manufacturer or Retapamulin GMP API supplier for your needs.
A Retapamulin CoA (Certificate of Analysis) is a formal document that attests to Retapamulin's compliance with Retapamulin specifications and serves as a tool for batch-level quality control.
Retapamulin CoA mostly includes findings from lab analyses of a specific batch. For each Retapamulin 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.
Retapamulin may be tested according to a variety of international standards, such as European Pharmacopoeia (Retapamulin EP), Retapamulin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Retapamulin USP).
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