01 2Kawaken Fine Chemicals Co., Ltd.
02 2Olon S. p. A.
01 1Japanese Pharmacopoeia Trihexyphenidyl Hydrochloride
02 1Japanese Pharmacopoeia trihexyphenidyl hydrochloride
03 1TRIHEXYPHENIDYL HYDROCHLORIDE
04 1Trihexyphenidyl hydrochloride
01 2Italy
02 2Japan
Japanese Pharmacopoeia Trihexyphenidyl Hydrochloride
Registration Number : 230MF10094
Registrant's Address : 2-3-3 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2018-07-26
Latest Date of Registration : 2018-07-26
Japanese Pharmacopoeia Trihexyphenidyl Hydrochloride
Registration Number : 218MF10866
Registrant's Address : 2-3-3 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2006-11-06
Latest Date of Registration : 2006-11-06
Registration Number : 227MF10190
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2015-08-03
Latest Date of Registration : 2023-05-24
Registration Number : 219MF10362
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2007-12-13
Latest Date of Registration : 2023-05-24
34
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A Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride, including repackagers and relabelers. The FDA regulates Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride 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 Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride supplier is an individual or a company that provides Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride active pharmaceutical ingredient (API) or Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride finished formulations upon request. The Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride suppliers may include Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride API manufacturers, exporters, distributors and traders.
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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 Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride Drug Master File in Japan (Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride JDMF) empowers Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride 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 Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Pharmaceutical Associates Brand of Trihexyphenidyl Hydrochloride 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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