01 1Novartis Ringaskiddy Limited@[Micronutrients Manufacturing Plant]Novartis Pharma Stein AG
01 1Samoh Pharmaceutical Co., Ltd.
01 1Pasireotide pamoate
01 1Switzerland
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2016-12-01
Registration Number : Number 2554-16-ND
Manufacturer Name : Novartis Ringaskiddy Limited...
Manufacturer Address : Ringaskiddy, Co. Cork, Ireland@Schaffhauserstrasse, CH-4332 Stein, Switzerland
A Pasireotide Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pasireotide Pamoate, including repackagers and relabelers. The FDA regulates Pasireotide Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pasireotide Pamoate 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 Pasireotide Pamoate supplier is an individual or a company that provides Pasireotide Pamoate active pharmaceutical ingredient (API) or Pasireotide Pamoate finished formulations upon request. The Pasireotide Pamoate suppliers may include Pasireotide Pamoate API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pasireotide Pamoate Drug Master File in Korea (Pasireotide Pamoate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pasireotide Pamoate. The MFDS reviews the Pasireotide Pamoate KDMF as part of the drug registration process and uses the information provided in the Pasireotide Pamoate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pasireotide Pamoate 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 Pasireotide Pamoate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pasireotide Pamoate suppliers with KDMF on PharmaCompass.
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