01 1RNLABORATORIES PVT.LTD
01 1Pharmasol Co., Ltd.
01 1Chlorhexidine gluconate solution
01 1India
Chlorhexidine gluconate solution
Registrant Name : Pharmasol Co., Ltd.
Registration Date : 2025-11-05
Registration Number : 20251105-211-J-2055
Manufacturer Name : RNLABORATORIES PVT.LTD
Manufacturer Address : Plot No 1 & 86, Special Economic Zone, Sachin, Surat, Gujarat, India
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A Dyna-hex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dyna-hex, including repackagers and relabelers. The FDA regulates Dyna-hex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dyna-hex 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 Dyna-hex supplier is an individual or a company that provides Dyna-hex active pharmaceutical ingredient (API) or Dyna-hex finished formulations upon request. The Dyna-hex suppliers may include Dyna-hex 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 Dyna-hex Drug Master File in Korea (Dyna-hex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dyna-hex. The MFDS reviews the Dyna-hex KDMF as part of the drug registration process and uses the information provided in the Dyna-hex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dyna-hex 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 Dyna-hex API can apply through the Korea Drug Master File (KDMF).
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