01 1Aurobindo Pharma Limited
02 1Dipharma Francis S. r. l.
03 2Kyongbo Pharmaceutical Co. , Ltd.
04 2Tateyama Chemical Co., Ltd.
01 3Entacapone
02 2Entacapone
03 1Entacapone "Tateyama"
01 1India
02 1Italy
03 2Japan
04 2South Korea
Registration Number : 227MF10029
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2015-01-23
Latest Date of Registration : 2015-11-20
Registration Number : 227MF10070
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2015-03-12
Registration Number : 227MF10041
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2015-02-09
Latest Date of Registration : 2015-02-09
Registration Number : 302MF10042
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2020-04-02
Latest Date of Registration : 2020-04-02
Registration Number : 230MF10071
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2018-06-07
Latest Date of Registration : 2018-06-07
Registration Number : 226MF10119
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2014-06-18
Latest Date of Registration : 2015-11-20
A Entacapone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entacapone, including repackagers and relabelers. The FDA regulates Entacapone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entacapone 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 Entacapone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entacapone supplier is an individual or a company that provides Entacapone active pharmaceutical ingredient (API) or Entacapone finished formulations upon request. The Entacapone suppliers may include Entacapone API manufacturers, exporters, distributors and traders.
click here to find a list of Entacapone 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 Entacapone Drug Master File in Japan (Entacapone JDMF) empowers Entacapone 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 Entacapone JDMF during the approval evaluation for pharmaceutical products. At the time of Entacapone 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 Entacapone suppliers with JDMF on PharmaCompass.
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