01 1Ajinomoto Co., Inc.
02 1Assia Chemical Industries Ltd.
03 1Aurobindo Pharma Limited
04 1Kyongbo Pharmaceutical Co. , Ltd.
01 1File stick bulk powder
02 2Nateglinide
03 1Nateglinide "Teva"
01 1India
02 1Israel
03 1Japan
04 1South Korea
Registration Number : 217MF10298
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-06-30
Latest Date of Registration : 2010-03-23
Registration Number : 223MF10114
Registrant's Address : Neot-Hovav Eco-Industrial Park, Emek Sara P. O. Box 2049 Be'er Sheva 8412316, Israel
Initial Date of Registration : 2011-07-25
Latest Date of Registration : 2012-05-15
Registration Number : 222MF10186
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2010-07-02
Latest Date of Registration : 2010-07-02
Registration Number : 224MF10051
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2012-03-12
Latest Date of Registration : 2024-06-27
A Nateglinide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nateglinide, including repackagers and relabelers. The FDA regulates Nateglinide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nateglinide 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 Nateglinide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nateglinide supplier is an individual or a company that provides Nateglinide active pharmaceutical ingredient (API) or Nateglinide finished formulations upon request. The Nateglinide suppliers may include Nateglinide API manufacturers, exporters, distributors and traders.
click here to find a list of Nateglinide 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 Nateglinide Drug Master File in Japan (Nateglinide JDMF) empowers Nateglinide 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 Nateglinide JDMF during the approval evaluation for pharmaceutical products. At the time of Nateglinide 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 Nateglinide suppliers with JDMF on PharmaCompass.
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