01 1Mallinckrodt Manufacturing LLC
01 1Synex Co., Ltd.
01 1Nitric oxide
01 1Ireland
Registrant Name : Synex Co., Ltd.
Registration Date : 2009-02-16
Registration Number : No. 693-1-ND
Manufacturer Name : Mallinckrodt Manufacturing L...
Manufacturer Address : 1060 Allendale Drive, Port Allen, LA 70767
A Nitric Oxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitric Oxide, including repackagers and relabelers. The FDA regulates Nitric Oxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitric Oxide 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 Nitric Oxide supplier is an individual or a company that provides Nitric Oxide active pharmaceutical ingredient (API) or Nitric Oxide finished formulations upon request. The Nitric Oxide suppliers may include Nitric Oxide API manufacturers, exporters, distributors and traders.
click here to find a list of Nitric Oxide 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 Nitric Oxide Drug Master File in Korea (Nitric Oxide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nitric Oxide. The MFDS reviews the Nitric Oxide KDMF as part of the drug registration process and uses the information provided in the Nitric Oxide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nitric Oxide 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 Nitric Oxide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nitric Oxide suppliers with KDMF on PharmaCompass.
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