01 1Alembic Pharmaceuticals Limited
02 1HANMI FINE CHEMICAL CO. , LTD.
03 1Honor Lab Limited
01 2Linagliptin
02 1linagliptin hydrate
01 2India
02 1South Korea
Registration Number : 305MF10137
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2023-12-19
Latest Date of Registration : 2023-12-19
Registration Number : 305MF10132
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2023-12-12
Latest Date of Registration : 2023-12-12
Registration Number : 305MF10029
Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.
Initial Date of Registration : 2023-02-15
Latest Date of Registration : 2023-02-15
A Linagliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linagliptin, including repackagers and relabelers. The FDA regulates Linagliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linagliptin 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 Linagliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Linagliptin supplier is an individual or a company that provides Linagliptin active pharmaceutical ingredient (API) or Linagliptin finished formulations upon request. The Linagliptin suppliers may include Linagliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Linagliptin 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 Linagliptin Drug Master File in Japan (Linagliptin JDMF) empowers Linagliptin 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 Linagliptin JDMF during the approval evaluation for pharmaceutical products. At the time of Linagliptin 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 Linagliptin suppliers with JDMF on PharmaCompass.
We have 3 companies offering Linagliptin
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
