01 1Bal Pharma Limited.
01 1Daeshin Muyak Co., Ltd.
01 1benzidamine hydrochloride
01 1India
Registrant Name : Daeshin Muyak Co., Ltd.
Registration Date : 2025-06-23
Registration Number : 20250623-211-J-1932
Manufacturer Name : Bal Pharma Limited.
Manufacturer Address : 61-B, Bommasandra Industrial Area Bangalore - 560 099, India
43
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A Difflam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difflam, including repackagers and relabelers. The FDA regulates Difflam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difflam 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 Difflam supplier is an individual or a company that provides Difflam active pharmaceutical ingredient (API) or Difflam finished formulations upon request. The Difflam suppliers may include Difflam 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 Difflam Drug Master File in Korea (Difflam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Difflam. The MFDS reviews the Difflam KDMF as part of the drug registration process and uses the information provided in the Difflam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Difflam 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 Difflam API can apply through the Korea Drug Master File (KDMF).
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