01 1Enzychem Life Sciences Co., Ltd. @Kekule Pharma Limited
02 3Glenmark Life Sciences Limited
03 1Glenmark Pharmaceuticals Limited
04 2H.L.G.Nomics Co., Ltd.
05 1Hunan Jiudian Hongyang Pharmaceutical.Co.,Ltd
06 1Hunan Warrant Chiral Pharmaceutical Co., Ltd.
07 2Hwail Pharmaceutical Co., Ltd. @Changzhou Pharmaceutical Factory
08 1Korea Biochem Pharmaceutical Co., Ltd.
09 1Kyungbo Pharmaceutical Co., Ltd. @Changzhou Pharmaceutical Factory
10 1M/s. Micro Labs Limited
11 2MSN Laboratories Private Limited
12 1Pfizer Asia Manufacturing Pte Ltd
13 1Pfizer Ireland Pharmaceuticals
14 2Phalanx Labs Private Limited
15 1Samjin Pharmaceutical Co., Ltd.
16 1Zhejiang LEPU Pharmaceutical Co., Ltd.
A Xeljanz manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xeljanz, including repackagers and relabelers. The FDA regulates Xeljanz manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xeljanz 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 Xeljanz manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xeljanz supplier is an individual or a company that provides Xeljanz active pharmaceutical ingredient (API) or Xeljanz finished formulations upon request. The Xeljanz suppliers may include Xeljanz API manufacturers, exporters, distributors and traders.
click here to find a list of Xeljanz 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 Xeljanz Drug Master File in Korea (Xeljanz KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xeljanz. The MFDS reviews the Xeljanz KDMF as part of the drug registration process and uses the information provided in the Xeljanz KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xeljanz 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 Xeljanz API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xeljanz suppliers with KDMF on PharmaCompass.
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