SIBLE CARE 19362011 UNION QUIMICO FARMACEUTICA, S.A. QUALITY CONTROL LABORATORY MICRONIZED CERTIFICATE OF ANALYSIS: ACYC LOVIR Batch No: 14071620003 Manufacturing date: 18/05/2016 Certificate numbé 46405 Retest date: May - 2021 TEST REQUIREMENTS RESULTS Description White to off white crystalline powder Complies Identification IR Passes test Passes test Identification HPLC Passes test Passes test Appearance of Must be clear and not more intensely Passes test ‘solution (1) coloured than Y7 Water (KFT) max. 6,0% 0,005% Ordinary impurities max. 1% Complies Assay HPLC (1) 98,5-101,0% 100,0% Residue on ignition max. 0,1% 0,08% RELATED SUBSTANCES (HPLC): Guanine max, 0,7% 0,09% RESIDUAL SOLVENTS: Ethy! alcohol max. 1000ppm 20 ppm There is no potential for class 1 solvents to be present and that the material, if tested, will comply with the stablished standards, Complies USP39; (1) Customer requirements. MANUFACTURING SITE: UNION QUIMICO FARMACEUTICAS Polig. Ind. Moli de les Planes, C/Font de Bocs, s!n* 08470 - Sant Celonl (Barcelona) Spain ‘This batch has been manufactured, packaged and tested in accordance EU GMP Guideline Volume 4 Part il (ICH Q7) “4 DATE OF RELEASE: 06/06/2016 APPROVED oe Page 1 of 3 Quality Coptol Manager Q.A. Responsible 8. Coto Y. Martinez5 39362011 UNION QUIMICO FARMACEUTICA, S.A. QUALITY CONTROL LABORATORY MICRONIZED CERTIFICATE OF ANALYSIS. ACYCLOVIR Batch No: 14071620003 Manufacturing date: 18/05/2016 46405 Retest date: May - 2024 TEST REQUIREMENTS RESULTS RELATED SUBSTANCES (HPLC): (1) Imp. A (Q-acetylaciclovir) max, 0,2% 0.01% Imp. B (Guanine) max. 0,7% 0.10% Imp. € (N7-aciclovir) max. 0,1% <0,01% Imp. F (N-acetylaciclovir) max. 0,1% <0,01% Imp. G (N9-diacetylaciclovir) max. 0,2% <0,01% Imp. | max. 0,10% 0.01% mp. J (VIR3/4) max. 0,10% 002% Imp. K#R max, 0,10% 0.03% Imp. N max. 0,5% 0,03% imp. 0 +a max. 0,5% <0,01% imp. P max. 0,2% <0,01% Any unspecified impurity max. 0,10% 0.01% Total max. 1,5% 0.23% ‘Complies USP39; (1) Customer requirements MANUFACTURING SITE: UNION QUIMICO FARMACEUTICA 8 Polig. Ind. Moli de les Planes, CiFont de Bocs, s!n* 08470 - Sant Celoni (Barcelona) Spain ‘This batch has been manufactured, packaged and tested in accordance EU GMP Guideline Volume 4 Part (ICH Q7) DATE OF RELEASE: 06/06/2016 APPROVED 4 Page 2 of 3 fol Manager QA. Responsible Y. Martinez \% RESPONSIBLE CARE ‘UALONGA 28-408 EARCELONA-=-ESPRA = TELEFOND: 9450467 4810-2408 4474 77-05 a 0176048 7408 sitet ‘AEISTRO MERCAITE OF BARCELONA, 19 240=-F 8 T 308 UBRO DE SOCEDADESINS 14~C1F A BOSSI -SOCEDAD UNPERSOHAL5 19362011 UNION QUIMICO FARMACEUTICA, S.A. QUALITY CONTROL LABORATORY MICRONIZED CERTIFICATE OF ANALYSIS. ACYCLOVIR Batch No: 14071620003 Manufacturing date: 15/05/2016 Certificate number: 46405 Retest date: May - 2021 TEST RI EN RESULTS PARTICLE SIZE DISTRIBUTION: (1) Volume mean diameter D[4,3] NMT 35 microns rc) Maximum size at 100% of population For information 45 um MICROBIOLOGICAL RESULTS (1): Total aerobic count (TAMC) ——-NMT 1000 cfuin 19 <10cfulg Total number of fungi (TYMC) —NMT 100 cfu in 1g <10cfulg P. Aeruginosa ‘Absence in 19 Absent 8. Aureus Absence in t g Absent E.Coli Absence in 1.9 Absent Complies USP39; (1) Customer requirements MANUFACTURING SITE: UNION QUIMICO FARMACEUTICA S Polig. Ind. Moll de les Planes, C/Font de Bocs, s/n® 08470 - Sant Celon| (Barcelona) Spain ‘This batch has been manufactured, packaged and tested in accordance EU GMP Guideline Volume 4 Parl (ICH G7) DATE OF RELEASE: 06/06/2016 APPROVED Y Page 3 of 3 Quality ContfofManager —_Q.A. Responsible 8. Coto Y. Martinez.