01 1Glenmark Life Sciences Limited
02 1Glenmark Life Sciences Ltd
03 1MSN Life Sciences Private Limited
04 1Micro Labs Limited
05 1YS Life Science Co., Ltd.
01 1Aging Life Science Co., Ltd.
02 1Eltek Pharmachem Co., Ltd.
03 1Kukjeon Pharmaceutical Co., Ltd.
04 1M-Peak Korea Co., Ltd.
05 1YS Life Science Co., Ltd.
01 5Lipitegrast
01 4India
02 1South Korea
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-02-17
Registration Number : 434-29-ND
Manufacturer Name : Glenmark Life Sciences Limit...
Manufacturer Address : Plot No. Z-103/I, SEZ Phase-II, Dahej, Taluka Vagra, District Bharuch, Gujarat - 392 ...
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2021-08-11
Registration Number : Number 812-15-ND
Manufacturer Name : Glenmark Life Sciences Ltd
Manufacturer Address : Plot No.Z-103/ I, DAHEJ SEZ Phase II, City : Dahej, District : Bharuch, Gujarat State...
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2024-11-12
Registration Number : Su469-7-ND
Manufacturer Name : Micro Labs Limited
Manufacturer Address : Plot No.43-45, KIADB, Bommasandra, Industrial Area, 4th Phase Anekal Taluk, Bengaluru...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-13
Registration Number : Number 173-41-ND
Manufacturer Name : MSN Life Sciences Private Li...
Manufacturer Address : Unit-ll, Sy.No.: Parts of 454, 455, 457, 458 & 459, Chandampet(Village), Shankarampet...
Registrant Name : YS Life Science Co., Ltd.
Registration Date : 2023-07-12
Registration Number : 2247-7-ND
Manufacturer Name : YS Life Science Co., Ltd.
Manufacturer Address : 207 Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do
A Lifitegrast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lifitegrast, including repackagers and relabelers. The FDA regulates Lifitegrast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lifitegrast 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 Lifitegrast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lifitegrast supplier is an individual or a company that provides Lifitegrast active pharmaceutical ingredient (API) or Lifitegrast finished formulations upon request. The Lifitegrast suppliers may include Lifitegrast API manufacturers, exporters, distributors and traders.
click here to find a list of Lifitegrast 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 Lifitegrast Drug Master File in Korea (Lifitegrast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lifitegrast. The MFDS reviews the Lifitegrast KDMF as part of the drug registration process and uses the information provided in the Lifitegrast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lifitegrast 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 Lifitegrast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lifitegrast suppliers with KDMF on PharmaCompass.
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