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 Prestwick3_001060 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_001060, including repackagers and relabelers. The FDA regulates Prestwick3_001060 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_001060 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Prestwick3_001060 supplier is an individual or a company that provides Prestwick3_001060 active pharmaceutical ingredient (API) or Prestwick3_001060 finished formulations upon request. The Prestwick3_001060 suppliers may include Prestwick3_001060 API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Prestwick3_001060 Drug Master File in Korea (Prestwick3_001060 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestwick3_001060. The MFDS reviews the Prestwick3_001060 KDMF as part of the drug registration process and uses the information provided in the Prestwick3_001060 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prestwick3_001060 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 Prestwick3_001060 API can apply through the Korea Drug Master File (KDMF).
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