01 2Olon SPA
02 1Pioneer Agro Industries Sanvin Laboratories Private Limited
01 1Agerson Bio Co., Ltd.
02 1Novartis Korea Ltd.
03 1Samoh Pharmaceutical Co., Ltd.
01 3Betaxolol hydrochloride
01 1India
02 2Italy
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-05-04
Registration Number : 20210323-209-J-906(A)
Manufacturer Name : Olon SPA
Manufacturer Address : Via Livelli, 1 26852 Casaletto Lodigiano fraz. Mairano (LO) Italy
Registrant Name : Novartis Korea Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-209-J-906
Manufacturer Name : Olon SPA
Manufacturer Address : Via Livelli, 1 26852 Casaletto Lodigiano fraz. Mairano (LO) Italy
Registrant Name : Agerson Bio Co., Ltd.
Registration Date : 2022-05-26
Registration Number : 20220526-209-J-1306
Manufacturer Name : Pioneer Agro Industries Sanv...
Manufacturer Address : Plot No.6,7,8,20&24 MIDC Industrial Area, Badlapur, Thane 421503 Maharashtra State, I...
A Betaxolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betaxolol, including repackagers and relabelers. The FDA regulates Betaxolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betaxolol 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 Betaxolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betaxolol supplier is an individual or a company that provides Betaxolol active pharmaceutical ingredient (API) or Betaxolol finished formulations upon request. The Betaxolol suppliers may include Betaxolol API manufacturers, exporters, distributors and traders.
click here to find a list of Betaxolol 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 Betaxolol Drug Master File in Korea (Betaxolol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betaxolol. The MFDS reviews the Betaxolol KDMF as part of the drug registration process and uses the information provided in the Betaxolol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betaxolol 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 Betaxolol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betaxolol suppliers with KDMF on PharmaCompass.
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