01 1Alembic Pharmaceuticals Limited
02 1Dottikon Exclusive Synthesis AG
03 1Hetero Labs Limited Unit-1
04 1Hetero Labs Limited Unit-I
05 1Hetero Labs Limited(Unit-1)
06 1Lonza AG
07 2MSN Laboratories Private Limited
01 1Aging Life Science Co., Ltd.
02 2AstraZeneca Korea Ltd.
03 1Iksoo Pharmaceutical Co., Ltd.
04 1Kukjeon Pharmaceutical Co., Ltd.
05 1Lee Sung International Co., Ltd.
06 1Lihu Healthcare Co., Ltd.
07 1Pharmapia Co., Ltd.
01 8Osimertinib mesylate
01 5India
02 1Switzerland
03 1U.S.A
04 1Blank
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2023-05-22
Registration Number : 434-56-ND
Manufacturer Name : Alembic Pharmaceuticals Limi...
Manufacturer Address : API Division Karakhadi, Plot No. 842-843 Tal-Padra, City : Karakhadi-391 450, Dist : ...
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2022-04-27
Registration Number : Su248-18-ND
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17 CH-5605 Dottikon Switzerland
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2023-12-29
Registration Number : Thu21-24-ND
Manufacturer Name : Hetero Labs Limited Unit-I
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2024-03-18
Registration Number : Thu21-24-ND(1)
Manufacturer Name : Hetero Labs Limited(Unit-1)
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2018-06-20
Registration Number : Su248-10-ND
Manufacturer Name : Lonza AG
Manufacturer Address : Lonzastrasse CH-3930 Visp Switzerland
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-12-19
Registration Number : No. 173-37-ND(1)
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-04-25
Registration Number : Number 173-37-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2024-10-30
Registration Number : Thu21-24-ND(2)
Manufacturer Name : Hetero Labs Limited Unit-1
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...
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A Osimertinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Osimertinib, including repackagers and relabelers. The FDA regulates Osimertinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Osimertinib 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 Osimertinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Osimertinib supplier is an individual or a company that provides Osimertinib active pharmaceutical ingredient (API) or Osimertinib finished formulations upon request. The Osimertinib suppliers may include Osimertinib API manufacturers, exporters, distributors and traders.
click here to find a list of Osimertinib 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 Osimertinib Drug Master File in Korea (Osimertinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Osimertinib. The MFDS reviews the Osimertinib KDMF as part of the drug registration process and uses the information provided in the Osimertinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Osimertinib 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 Osimertinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Osimertinib suppliers with KDMF on PharmaCompass.
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