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API SUPPLIERS
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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ABOUT THIS PAGE
A Belotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Belotecan, including repackagers and relabelers. The FDA regulates Belotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Belotecan 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 Belotecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Belotecan supplier is an individual or a company that provides Belotecan active pharmaceutical ingredient (API) or Belotecan finished formulations upon request. The Belotecan suppliers may include Belotecan API manufacturers, exporters, distributors and traders.
click here to find a list of Belotecan 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 Belotecan Drug Master File in Korea (Belotecan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Belotecan. The MFDS reviews the Belotecan KDMF as part of the drug registration process and uses the information provided in the Belotecan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Belotecan 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 Belotecan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Belotecan suppliers with KDMF on PharmaCompass.
Belotecan 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 Belotecan 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 Belotecan GMP manufacturer or Belotecan GMP API supplier for your needs.
A Belotecan CoA (Certificate of Analysis) is a formal document that attests to Belotecan's compliance with Belotecan specifications and serves as a tool for batch-level quality control.
Belotecan CoA mostly includes findings from lab analyses of a specific batch. For each Belotecan 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.
Belotecan may be tested according to a variety of international standards, such as European Pharmacopoeia (Belotecan EP), Belotecan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Belotecan USP).
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