Naloxone 3-methylether API Manufacturers with CoA, DMF, GMP, WC
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Looking for Naloxone 3-methylether API 131830-09-6?
- Description:
- Here you will find a list of producers, manufacturers and distributors of Naloxone 3-methylether. You can filter on certificates such as GMP, FDA, CEP, Written Confirmation and more. Send inquiries for free and get in direct contact with the supplier of your choice.
- API | Excipient name:
- Naloxone 3-methylether
- Synonyms:
- Naloxone Methyl Ether
- Cas Number:
- 131830-09-6
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Written Confirmation
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document set up by the health authorities of the country where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to regularly take place in the future.
Drug Master File
A drug master file is a document submitted to governmental bodies that contains all details of the manufacturing process of an API or medicine. This includes information on chemical properties, the facilities used, the processes used, details on packaging, storage, et cetera. In order to protect the intellectual property of the manufacturer, this document is confidential. Countries may have different guidance compared to other countries, that’s why different types of DMF exist. For example, you may have a US DMF, ASMF (formally known as EDMF), Japanese DMF, Chinese DMF, et cetera.
