01 1Glaxo Wellcome Manufacturing Pte Ltd
02 2HIKAL Ltd.
01 1Samil Pharmaceutical Co., Ltd.
02 1Seongi Bio Co., Ltd.
03 1Sungjin Exim Co., Ltd.
01 3Ondansetron
01 2India
02 1United Kingdom
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2010-12-30
Registration Number : 20101230-47-B-303-15
Manufacturer Name : Glaxo Wellcome Manufacturing...
Manufacturer Address : 1 Pioneer Sector 1 Singapore 628413
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2013-05-10
Registration Number : 20130510-47-B-349-18
Manufacturer Name : HIKAL Ltd.
Manufacturer Address : 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore-562105, Karnataka, India
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2020-06-19
Registration Number : 20130510-47-B-349-18(2)
Manufacturer Name : HIKAL Ltd.
Manufacturer Address : 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore-562105, Karnataka, India
A Ondansetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ondansetron, including repackagers and relabelers. The FDA regulates Ondansetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ondansetron 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 Ondansetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ondansetron supplier is an individual or a company that provides Ondansetron active pharmaceutical ingredient (API) or Ondansetron finished formulations upon request. The Ondansetron suppliers may include Ondansetron API manufacturers, exporters, distributors and traders.
click here to find a list of Ondansetron 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 Ondansetron Drug Master File in Korea (Ondansetron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ondansetron. The MFDS reviews the Ondansetron KDMF as part of the drug registration process and uses the information provided in the Ondansetron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ondansetron 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 Ondansetron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ondansetron suppliers with KDMF on PharmaCompass.
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