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
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PharmaCompass offers a list of Linagliptin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Linagliptin manufacturer or Linagliptin supplier for your needs.
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A JENTADUETO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of JENTADUETO, including repackagers and relabelers. The FDA regulates JENTADUETO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. JENTADUETO API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A JENTADUETO supplier is an individual or a company that provides JENTADUETO active pharmaceutical ingredient (API) or JENTADUETO finished formulations upon request. The JENTADUETO suppliers may include JENTADUETO API manufacturers, exporters, distributors and traders.
click here to find a list of JENTADUETO 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 JENTADUETO Drug Master File in Japan (JENTADUETO JDMF) empowers JENTADUETO 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 JENTADUETO JDMF during the approval evaluation for pharmaceutical products. At the time of JENTADUETO JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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