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 Indolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indolin, including repackagers and relabelers. The FDA regulates Indolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indolin 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 Indolin supplier is an individual or a company that provides Indolin active pharmaceutical ingredient (API) or Indolin finished formulations upon request. The Indolin suppliers may include Indolin 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 Indolin Drug Master File in Korea (Indolin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Indolin. The MFDS reviews the Indolin KDMF as part of the drug registration process and uses the information provided in the Indolin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Indolin 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 Indolin API can apply through the Korea Drug Master File (KDMF).
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