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 pHiso-Med manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of pHiso-Med, including repackagers and relabelers. The FDA regulates pHiso-Med manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. pHiso-Med 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 pHiso-Med supplier is an individual or a company that provides pHiso-Med active pharmaceutical ingredient (API) or pHiso-Med finished formulations upon request. The pHiso-Med suppliers may include pHiso-Med API manufacturers, exporters, distributors and traders.
click here to find a list of pHiso-Med suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a pHiso-Med Drug Master File in Korea (pHiso-Med KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of pHiso-Med. The MFDS reviews the pHiso-Med KDMF as part of the drug registration process and uses the information provided in the pHiso-Med KDMF to evaluate the safety and efficacy of the drug.
After submitting a pHiso-Med 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 pHiso-Med API can apply through the Korea Drug Master File (KDMF).
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