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PharmaCompass offers a list of Lixisenatide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lixisenatide manufacturer or Lixisenatide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lixisenatide manufacturer or Lixisenatide supplier.
PharmaCompass also assists you with knowing the Lixisenatide API Price utilized in the formulation of products. Lixisenatide API Price is not always fixed or binding as the Lixisenatide Price is obtained through a variety of data sources. The Lixisenatide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lixisenatide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lixisenatide, including repackagers and relabelers. The FDA regulates Lixisenatide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lixisenatide 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 Lixisenatide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lixisenatide supplier is an individual or a company that provides Lixisenatide active pharmaceutical ingredient (API) or Lixisenatide finished formulations upon request. The Lixisenatide suppliers may include Lixisenatide API manufacturers, exporters, distributors and traders.
click here to find a list of Lixisenatide 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 Lixisenatide Drug Master File in Korea (Lixisenatide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lixisenatide. The MFDS reviews the Lixisenatide KDMF as part of the drug registration process and uses the information provided in the Lixisenatide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lixisenatide 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 Lixisenatide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lixisenatide suppliers with KDMF on PharmaCompass.
Lixisenatide 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 Lixisenatide 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 Lixisenatide GMP manufacturer or Lixisenatide GMP API supplier for your needs.
A Lixisenatide CoA (Certificate of Analysis) is a formal document that attests to Lixisenatide's compliance with Lixisenatide specifications and serves as a tool for batch-level quality control.
Lixisenatide CoA mostly includes findings from lab analyses of a specific batch. For each Lixisenatide 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.
Lixisenatide may be tested according to a variety of international standards, such as European Pharmacopoeia (Lixisenatide EP), Lixisenatide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lixisenatide USP).