01 1Chongqing Huapont Shengchem Pharm. Co. , Ltd.
02 1Curia Spain S. A. U.
03 1F. I. S. Fabrica Italiana Sintetici S. p. A.
04 1Glenmark Life Sciences Limited
05 1KOLON LIFE SCIENCE, INC.
06 1Kyowa Pharma Chemical Co., Ltd.
07 1MSN Laboratories Private Limited.
08 2Sanyo Chemical Research Institute Co., Ltd.
09 2Sumitomo Chemical Co., Ltd.
01 1Japanese Pharmacopoeia olopatadine hydrochloride (production only)
02 2Olopatadine Hydrochloride
03 1Olopatadine Hydrochloride (Olopatadine HCl)
04 6Olopatadine hydrochloride
05 1Olopatadine hydrochloride (K)
01 1China
02 2Gabon
03 2India
04 1Italy
05 3Japan
06 1South Korea
07 1U.S.A
Olopatadine Hydrochloride (Olopatadine HCl)
Registration Number : 303MF10171
Registrant's Address : No. 69 Xingguang Avenue, Renhe Town, Yubei District, Chongqing, China
Initial Date of Registration : 2021-12-02
Latest Date of Registration : 2021-12-02
Registration Number : 305MF10136
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2023-12-19
Latest Date of Registration : 2023-12-19
Registration Number : 223MF10009
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2011-01-21
Latest Date of Registration : 2023-07-12
Registration Number : 304MF10045
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Mahara...
Initial Date of Registration : 2022-02-24
Latest Date of Registration : 2022-02-24
Japanese Pharmacopoeia Olopatadine Hydrochloride (for manufacturing only)
Registration Number : 226MF10140
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2014-07-31
Latest Date of Registration : 2016-06-06
Registration Number : 224MF10094
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2012-04-27
Latest Date of Registration : 2021-06-01
Registration Number : 222MF10280
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2010-12-24
Latest Date of Registration : 2012-05-22
Registration Number : 225MF10202
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2013-11-11
Latest Date of Registration : 2013-11-11
Registration Number : 228MF10129
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2016-07-15
Latest Date of Registration : 2016-07-15
Registration Number : 222MF10190
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2010-07-07
Latest Date of Registration : 2012-04-11
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A Opatanol;Pataday;Patanase;Allelock supplier is an individual or a company that provides Opatanol;Pataday;Patanase;Allelock active pharmaceutical ingredient (API) or Opatanol;Pataday;Patanase;Allelock finished formulations upon request. The Opatanol;Pataday;Patanase;Allelock suppliers may include Opatanol;Pataday;Patanase;Allelock 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 Opatanol;Pataday;Patanase;Allelock Drug Master File in Japan (Opatanol;Pataday;Patanase;Allelock JDMF) empowers Opatanol;Pataday;Patanase;Allelock 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 Opatanol;Pataday;Patanase;Allelock JDMF during the approval evaluation for pharmaceutical products. At the time of Opatanol;Pataday;Patanase;Allelock 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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