swissmedic
Transcription
swissmedic
swissmedic CERTIFICATE OF GMP COMPLIANCE Wecertify herewith that the company Biosynth AG, 9425 Thai, Switzerland with its site Biosynth AG, Rietlistrasse 4, 9422 Staad, Switzerland, has been duly authorized to manufacture and distributeactive pharmaceutical ingredients (APIs),the manufacturing licence excluding sterile API restricted to 5-aminolevulinic acid hydrochloride and histamine dihydrochloride; that the company is keeping the required levelfor good practices inthe manufacture of active pharmaceutical ingredients according to the Swiss regulations inforce. These regulations are inaccordance with the requirements for good practices inthe manufacture andquality control ofthe Pharmaceutical Inspection Convention/Co-operation Scheme(PIC/S)andthe Directives of the European Commission; that the manufacturing plant of the company is subject to official periodic inspections; the last regular inspection was conducted on May 19,2015; that the requirements regarding manufacture and quality control for active pharmaceutical ingredients for export are identical tothose applicable toAPIs soldinSwitzerland. Berne,August 10,2015 No. 15-1575 Schweizerisches HeiImitteIinstitut Institutsuissedes produits thérapeutiques Istituto svizzero pergliagenti terapeutici Swiss Agency forTherapeutic Products Swissmedic, Swiss Agency for T/ieraoewlc Products l-303.AA.01-A02e/ V02/ bja/gme/ smi/ 30.05.11 Swissmedic | Hallerstrasse 7 | Postfach | CH-3000 Bern 9 |www.swissmedic.ch |Tel. +41 58 462 02 11 | Fax +41 58 462 02 12