01 1Zambon Group SpA
01 1Sam-O Pharmaceutical Co., Ltd.
01 1Oxaprozine
01 1Italy
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-54-C-180-03
Manufacturer Name : Zambon Group SpA
Manufacturer Address : Via Dovaro 36045 Almisano di Lonigo (Vicenza) (Via della Chimica, 9, 36100 Vicenza), ...
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A Alvo manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alvo, including repackagers and relabelers. The FDA regulates Alvo manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alvo 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 Alvo manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Alvo supplier is an individual or a company that provides Alvo active pharmaceutical ingredient (API) or Alvo finished formulations upon request. The Alvo suppliers may include Alvo API manufacturers, exporters, distributors and traders.
click here to find a list of Alvo suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Alvo Drug Master File in Korea (Alvo KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alvo. The MFDS reviews the Alvo KDMF as part of the drug registration process and uses the information provided in the Alvo KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alvo 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 Alvo API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alvo suppliers with KDMF on PharmaCompass.
