TAKEDA AUSTRIA GmbH ‘St Polar Strasse 25 CERTIFICATE OF COMPLIANCE Name of Product: ENTYVIO® ‘Strength / Potency: 300 mg Vetslizumab Dosage form: powder for concentrate for solution for infusion Package size: 1 vial Importing country: Indonesia Material number: e14a411 Batch number: 12105508, Batch number bulk: 507421 Customer Batch number bulk 505587 Date of manufacture 30/04/2021 Expiry date: oi2az4 Certication statement {hereby cerily that all the manufacturing stages of this batch of fished product have been carried out in ful ‘Compliance with the GMP requirements of the EU and [when within the EU] with the requirements of the Marketing Authorisation) ofthe destination courtty/countres, Note: This product must be stored and transported between 2°C and 8°C. $7AUG.2021 09:29:69 (CET+1) Birgt Spitzer-Sonnlatiner (ZORA470) Date of Signature Name of Qualified Person ‘Signed in SAP with electronic signature (cT_18, 000068 v03 r4a4y4 12108508, CT_10_000268_V01_ coe Brat sptzer Senisinee 17.AUG 2021 99:29:89 (CET)CERTIFICATE OF ANALYSIS poge 1/2 Better Health, Brighter Future 16.08.2021 ~QA/KA ENTYV10° 300 mg Powder for concentrate for solution for infusion, 300 mg Vedoliumat Charge profile by Isoelectric Focusing: | conforms Charge profile by Cation-Exchange Chromatography: conforms Potency: ut 78 Binding Assy: 389% Assay by UV: 11% Parlty/ Impurity: CESSDS Reduced: conforms | 9936 CESDS Non-reduced: conforms 97% 27% Takeda Austria GmbH Tateoa Aus Gr St Peterstrace 25 Cosel schatt mt beihrdnkter na0z0 une Hattung, Ragetnet be'm Landes Te. #43732 69190 gerehn Cael Far +43-732 65 60 ine unter #N 230647 v Dan onarse2 Batch no: 12108508 Batch no. bulk: 507421 (508587) Manufacture date: 04/2021 Expiry date: 03/2024 Tests Results ‘Specification DN-000087795 Ver. 2.0 (0600%-SPF-0000097.02) Gonerat: Appearance - Cake conforms white to off white cake or powder Moisture content ~ Cate: 07% £22% Reconstitution time ~ Cake; 14 minutes $30 minutes (Clarity and colour of solution: conforms lear or opalescent, colourless to brownish-vllow solution, essentially jree of foreign mattor phe 62 63203 Content wniformity: ‘meets USP/EP meets USP/EP 13% AVE 150% Particulate matter: conforms mets USP/EP 210 pm: 12 particles / container $6000 particles / container 225 pm O particles / comainer $600 particles / container entity: conforms to reference standard conforms to reference standard 60-140 96 of reference standard 100~ 120 % of tabet claim conforms to reference standard Heavy + Light chain > 97 % conforms to reference standard IgG 295 % MW $4.0% Takeda Austria Cob Unite tablty Company, Regiseres inthe Companies Register ofthe tine Regional Cour under Fh 250817 Corporate Seat tine ym 0487592Takeda® CERTIFICATE OF ANALYSIS: page 22 Better Health, Brighter Future 16.08.2021 - Q4/KA ENTYVIO¥ 300 mg Powder for concentrate for solution for infusion, 300 mg Vedolizumab Batch no: Batch no. bulk: r210s808 ‘907421 (505587) ‘Specification DN-000057795 Ver. 2.0 (0600X-SP-0000097.02) Charge profile by Cation-Exchange Chromatography: ‘Size-exsluston chromatography: 9% Monomer: 96 Aggregates Safety: Bacterial endotoxin: <0. Bung Sterility: no growth ties Ponon ct Sent “Takeda Austria GmbH “ace Atria Co Steer stase 25 chat beschakter aa0z0.une no, Regist beam Landes Te. +43 73269190 ‘evict ine ater FV 23081 7 Fax 43 132 65 60.66 Ceescnatsst: |e ov 088: Major Isoform > 55.0% Monomer > 96.0 % Aggregates <2.0% $0.5 EUimg MLNOOO2 no growil Lite ia ey Comany, egiered inthe Compares Ragster ofthe tine Regona Caurtunder FX 230647 v Corporat Seat tire pum oas7s92