01 1Alembic Pharmaceuticals Limited
02 1Dottikon Exclusive Synthesis AG
03 1Lonza AG
04 1Olon SpA
01 2AstraZeneca Korea Ltd.
02 1Eltek Pharmachem Co., Ltd.
03 1Klasia Co., Ltd.
01 4Olaparib
01 1India
02 1Italy
03 1Switzerland
04 1U.S.A
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2022-06-27
Registration Number : Su469-5-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 : 2019-10-29
Registration Number : Su248-11-ND
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17 CH-5605 Dottikon Switzerland
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2019-10-29
Registration Number : Su248-12-ND
Manufacturer Name : Lonza AG
Manufacturer Address : Lonzastrasse, 3930 Visp, Switzerland
Registrant Name : Klasia Co., Ltd.
Registration Date : 2024-10-02
Registration Number : No. 758-14-ND
Manufacturer Name : Olon SpA
Manufacturer Address : Strada Rivoltana, km 6/7 20053 Rodano (MI) Italy
A Olaparib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olaparib, including repackagers and relabelers. The FDA regulates Olaparib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olaparib 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 Olaparib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olaparib supplier is an individual or a company that provides Olaparib active pharmaceutical ingredient (API) or Olaparib finished formulations upon request. The Olaparib suppliers may include Olaparib API manufacturers, exporters, distributors and traders.
click here to find a list of Olaparib 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 Olaparib Drug Master File in Korea (Olaparib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olaparib. The MFDS reviews the Olaparib KDMF as part of the drug registration process and uses the information provided in the Olaparib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Olaparib 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 Olaparib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Olaparib suppliers with KDMF on PharmaCompass.
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