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01 1Sanofi Chimie
02 1Sanofi Winthrop Industrie
03 1Sun Pharmaceutical Industries Limited
01 1Korea Mundi Pharma Co., Ltd.
02 1Masung LS Co., Ltd.
03 1Samoh Pharmaceutical Co., Ltd.
01 1Naloxone hydrochloride dihydrate
02 2naloxone hydrochloride
01 2France
02 1India
Registrant Name : Korea Mundi Pharma Co., Ltd.
Registration Date : 2013-06-14
Registration Number : 20130507-176-I-164-01(1)
Manufacturer Name : Sanofi Chimie
Manufacturer Address : Route d'Avignon 30390 Aramon France
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-05-07
Registration Number : 20130507-176-I-164-01
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Route d'Avignon 30390 Aramon France
Naloxone hydrochloride dihydrate
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2024-12-30
Registration Number : 20241230-176-I-684-02
Manufacturer Name : Sun Pharmaceutical Industrie...
Manufacturer Address : Plot No. 24/2 & 25, Phase-Ⅳ, GIDC Industrial Zone AT & Post. Panoli - 394 116, Dist...
A Naloxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxone, including repackagers and relabelers. The FDA regulates Naloxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Naloxone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naloxone supplier is an individual or a company that provides Naloxone active pharmaceutical ingredient (API) or Naloxone finished formulations upon request. The Naloxone suppliers may include Naloxone API manufacturers, exporters, distributors and traders.
click here to find a list of Naloxone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Naloxone Drug Master File in Korea (Naloxone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naloxone. The MFDS reviews the Naloxone KDMF as part of the drug registration process and uses the information provided in the Naloxone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naloxone 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 Naloxone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naloxone suppliers with KDMF on PharmaCompass.
We have 2 companies offering Naloxone
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