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