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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
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ABOUT THIS PAGE
A Gemigliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemigliptin, including repackagers and relabelers. The FDA regulates Gemigliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemigliptin 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 Gemigliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemigliptin supplier is an individual or a company that provides Gemigliptin active pharmaceutical ingredient (API) or Gemigliptin finished formulations upon request. The Gemigliptin suppliers may include Gemigliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Gemigliptin 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 Gemigliptin Drug Master File in Korea (Gemigliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemigliptin. The MFDS reviews the Gemigliptin KDMF as part of the drug registration process and uses the information provided in the Gemigliptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gemigliptin 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 Gemigliptin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gemigliptin suppliers with KDMF on PharmaCompass.
Gemigliptin 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 Gemigliptin 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 Gemigliptin GMP manufacturer or Gemigliptin GMP API supplier for your needs.
A Gemigliptin CoA (Certificate of Analysis) is a formal document that attests to Gemigliptin's compliance with Gemigliptin specifications and serves as a tool for batch-level quality control.
Gemigliptin CoA mostly includes findings from lab analyses of a specific batch. For each Gemigliptin 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.
Gemigliptin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gemigliptin EP), Gemigliptin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gemigliptin USP).
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