01 1Tianish Laboratories Private Limited
01 1Tofacitinib Citrate
01 1U.S.A
Registration Number : 305MF10124
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2023-11-29
Latest Date of Registration : 2023-11-29
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Xeljanz Drug Master File in Japan (Xeljanz JDMF) empowers Xeljanz API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Xeljanz JDMF during the approval evaluation for pharmaceutical products. At the time of Xeljanz JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Xeljanz suppliers with JDMF on PharmaCompass.
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