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