Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab Private Limited
02 1Newchem S. p. A.
03 1Symbiotica Specialty Ingredients Sdn. Bhd.
04 1Viyash Life Sciences Private Limited
01 1Clobetasone butyrate
02 2Clobetasone butyric acid ester
03 1Pramipexole hydrochloride hydrate
01 1India
02 1Italy
03 1Malaysia
04 1U.S.A
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Registration Number : 229MF10100
Registrant's Address : 385/2, Pigdamber, Off. A. B. Road, Rau, Indore 453331 (M.P.) India
Initial Date of Registration : 2017-06-02
Latest Date of Registration : 2017-06-02
Registration Number : 219MF10361
Registrant's Address : Via San Vittore, 39-20123 Milano (Italy)
Initial Date of Registration : 2007-12-13
Latest Date of Registration : 2007-12-13
Registration Number : 228MF10101
Registrant's Address : No. 518, Jalan Waja 4, Taman Industry Waja, 09000 Kulim, Kedah Darul Aman, Malaysia
Initial Date of Registration : 2016-05-27
Latest Date of Registration : 2016-05-27
Pramipexole hydrochloride hydrate
Registration Number : 223MF10165
Registrant's Address : Plot No. 290, Srivalli's Corporate, Road No. 6, Kakatiya Hills, Madhapur, Hyderabad-5...
Initial Date of Registration : 2011-11-28
Latest Date of Registration : 2011-11-28
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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 Clobetasone 17-Butyrate Drug Master File in Japan (Clobetasone 17-Butyrate JDMF) empowers Clobetasone 17-Butyrate 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 Clobetasone 17-Butyrate JDMF during the approval evaluation for pharmaceutical products. At the time of Clobetasone 17-Butyrate 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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