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ABOUT THIS PAGE
A Limaprost Alfadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Limaprost Alfadex, including repackagers and relabelers. The FDA regulates Limaprost Alfadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Limaprost Alfadex 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 Limaprost Alfadex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Limaprost Alfadex supplier is an individual or a company that provides Limaprost Alfadex active pharmaceutical ingredient (API) or Limaprost Alfadex finished formulations upon request. The Limaprost Alfadex suppliers may include Limaprost Alfadex API manufacturers, exporters, distributors and traders.
click here to find a list of Limaprost Alfadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Limaprost Alfadex Drug Master File in Japan (Limaprost Alfadex JDMF) empowers Limaprost Alfadex API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Limaprost Alfadex JDMF during the approval evaluation for pharmaceutical products. At the time of Limaprost Alfadex JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Limaprost Alfadex suppliers with JDMF 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 Limaprost Alfadex Drug Master File in Korea (Limaprost Alfadex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Limaprost Alfadex. The MFDS reviews the Limaprost Alfadex KDMF as part of the drug registration process and uses the information provided in the Limaprost Alfadex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Limaprost Alfadex 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 Limaprost Alfadex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Limaprost Alfadex suppliers with KDMF on PharmaCompass.
Limaprost Alfadex 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 Limaprost Alfadex 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 Limaprost Alfadex GMP manufacturer or Limaprost Alfadex GMP API supplier for your needs.
A Limaprost Alfadex CoA (Certificate of Analysis) is a formal document that attests to Limaprost Alfadex's compliance with Limaprost Alfadex specifications and serves as a tool for batch-level quality control.
Limaprost Alfadex CoA mostly includes findings from lab analyses of a specific batch. For each Limaprost Alfadex 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.
Limaprost Alfadex may be tested according to a variety of international standards, such as European Pharmacopoeia (Limaprost Alfadex EP), Limaprost Alfadex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Limaprost Alfadex USP).
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