01 2KYUNG DONG PHARM. C.O. , LTD.
02 1Organic Synthesis Chemicals Co., Ltd.
03 1Permakem Asia Co., Ltd.
04 2Polaris AI Pharma Corp.
01 1Hydrochloric acid roxatidine acetate
02 1Roxatidine Acetate Hydrochloride
03 3Roxatidine acetate hydrochloride
04 1Roxatidine acetate hydrochloride (prepared only)
01 2Japan
02 4South Korea
Roxatidine Acetate Hydrochloride
Registration Number : 228MF10110
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2016-06-08
Latest Date of Registration : 2016-06-08
Roxatidine acetate hydrochloride (for manufacturing only)
Registration Number : 218MF10789
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2014-04-02
Roxatidine Acetate Hydrochloride
Registration Number : 301MF10100
Registrant's Address : 3F SMART-K Bldg. B, 26, Gwacheon-daero 7-gil, Gwacheon-si, Gyeonggi-do, Republic of K...
Initial Date of Registration : 2019-11-27
Latest Date of Registration : 2019-11-27
Roxatidine Acetate Hydrochloride
Registration Number : 226MF10169
Registrant's Address : 9FL, KyungDong Pharm Bldg, 1926, Nambusunhwan-ro, Gwanak-gu, Seoul, Republic of Korea
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2014-09-01
Roxatidine acetate hydrochloride
Registration Number : 217MF10722
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2009-01-13
Roxatidine Acetate Hydrochloride
Registration Number : 219MF10219
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2007-07-06
Latest Date of Registration : 2007-07-06
A Roxatidine Acetate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roxatidine Acetate Hydrochloride, including repackagers and relabelers. The FDA regulates Roxatidine Acetate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roxatidine Acetate 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.
click here to find a list of Roxatidine Acetate Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Roxatidine Acetate Hydrochloride supplier is an individual or a company that provides Roxatidine Acetate Hydrochloride active pharmaceutical ingredient (API) or Roxatidine Acetate Hydrochloride finished formulations upon request. The Roxatidine Acetate Hydrochloride suppliers may include Roxatidine Acetate Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Roxatidine Acetate Hydrochloride 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 Roxatidine Acetate Hydrochloride Drug Master File in Japan (Roxatidine Acetate Hydrochloride JDMF) empowers Roxatidine Acetate 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 Roxatidine Acetate Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Roxatidine Acetate Hydrochloride 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 Roxatidine Acetate Hydrochloride suppliers with JDMF on PharmaCompass.
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