01 1Symbiotica Specialty Ingredients Sdn. Bhd.
01 1Insung Trading Co., Ltd.
01 1Betamethasone sodium phosphate
01 1Malaysia
Betamethasone sodium phosphate
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2021-07-22
Registration Number : 20210722-210-J-1076
Manufacturer Name : Symbiotica Specialty Ingredi...
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
70
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A Bentelan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bentelan, including repackagers and relabelers. The FDA regulates Bentelan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bentelan 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 Bentelan supplier is an individual or a company that provides Bentelan active pharmaceutical ingredient (API) or Bentelan finished formulations upon request. The Bentelan suppliers may include Bentelan 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 Bentelan Drug Master File in Korea (Bentelan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bentelan. The MFDS reviews the Bentelan KDMF as part of the drug registration process and uses the information provided in the Bentelan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bentelan 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 Bentelan API can apply through the Korea Drug Master File (KDMF).
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