Certificate of Conformity (Conformation as per Annex 16 of EU cGMP Rules) Name of Product Controloc 20 mg Gastro-resistant Tablets (ROU) Importing Country _| Romania Material no. Finished | 4054490 Goods Lot/Batch no. 365170 hed Goods Material no. Bulk 6109959 Lot/Batch no. Bulk | 11255402 Strength/Potency Dosage Form Package Size/Type Pantoprazole 20 mg Gastro-resistant tablets 30 pieces / Blister Manufacture Date 30.09.2016 Batch Size 104,130 Pieces Expiry Date 09/2019 Name and address of fabricator(s) / manufacturer(s) / manufacturing site(s) Date / Number of Manufacturing Authorisation / ‘Authority Sites 2016-07-04 DE_BB_01_MIA_2016_0020/G4-5421. 04/takeda/04/04.07.2016 Landesamt for Umwelt, Gesundheit und Verbraucherschutz des Landes Brandenburg, Abt. Gesundheit, \Wansdorf Germany Takeda GmbH Plant Oranienburg Lehnitzstrae 70 - 98 16515 Oranienbura, Germany Comments / Remarks None Takeda GmbH Plant Oranienburg LehnitastraBe 70 - 98 16515 Oranienburo, Germany Cen. of Conformance (COC) setup Version: 2 Repomt $3978 Date: 15.11.2026/17:32:96. From: UMSORAP Seite 1 von 2Certificate of Conformity (Conformation as per Annex 16 of EU cGMP Rules) Name of Product Controloc 20 mg Gastro-resistant Tablets (ROU) Importing Country _ | Romania Material no. Finished | 4054490 Goods Lot/Batch no. 365170 Finished Goods Material no. Bulk 6109959 Lot/Batch no. Bulk | 11255402 Certification statement Hereby we certify for the above product batch as follows: This product batch is manufactured in compliance with the current EU- and national legislation, the requirements of the Marketing Authorisation and the valid Manufacturing Authorisation. The production, packaging and testing documentation for the bulk and the finished goods is complete and was checked and confirmed. All deviations have been evaluated as per predefined internal processes and approved. Released by a Qualified Person. Person authorizing th 1e Batch release Date of signature Signature Dr. Ulrike Schub Qualified Person 15.11.2016 This is an electronic signature according to EU EudraLex Volume 4 Annex 11 and US Title 21 Code of Federal Regulations Part 11. Takeda GmbH Plant Oranienburg LehnitzstraBe 70 - 98, 16515 Oranienburg, Germany cor of Conformance (COC) setup Version: 2 Report: §3978 Date: 25.11.2016/27:32:36 From: LIMSORAP Seite 2 von 2Controloc 20 mg Gastro-resistant Tablets (ROU) Tested according: Product specification Q00073412 Version 2.0 Batch no. 365170 Product code: 4054490 Manufacture Date: 30.09.2016 Bulk Product no. 6109959 Bulk Batch no. 11255402 Analysis date 26.10.2016 Expiry Date: 09/2019 TEST NOMINAL RESULT Appearance Appearance Yellow, oval, biconvex film-coated Complies tablets with white to almost white cores, printed on one side with "P20". The gastro-resistant tablets must be of uniform shape, colour and size. Mass Average mass 106.0 mg + 5% 104.1 mg Disintegration time Acid stage Buffer stage Loss on drying Loss on drying Identity Identity (HPLC) Identity (NIR) Iron oxide Titanium dioxide* * Not part of routine release testing; test once the year. Purity HPLC B8401-026 (Impurity C) 8610-014 (Impurity A) 8810-044 (Impurity D and F) 8510-028 (Impurity 8) Unidentified by-products, individually (200.7 - 111.3 mg) According to Ph. Eur.2.9.1 No disintegration over 2 h in 0.1 N_ Complies hydrochloric acid; followed by disintegration in pH 15 min 6.8 phosphate buffer 2.0 - 7.0% 3.8% Pantoprazole positive Pantoprazole positive Positive Positive Not performed Positive Not performed Not more than 0.1 % (w/w) <0.004 % Not more than 0.5 % (w/w) 0.09 % Not more than 0.2 % (w/w) 0.04 % Not more than 0.1 % (w/w) <0.01 % Not more than 0.2 % (w/w) 0.05 % ‘Takeda GmbH Plant Oranienburg Lehnitzstrae 70 - 98 16515 oranienburg, Germany Cert of Analysis TOB Version: 2 Report: $3977 Date: 15.11.2026/17:22:27 From: LINSORAP Selte 1 von 3Controloc 20 mg Gastro-resistant Tablets (ROU) Product specification Q00073412 Version 2.0 Tested according: Batch no. 365170 Product code: 4054490 Manufacture Date: 30.09.2016 Bulk Product no. 6109959 Bulk Batch no.: 11255402 Analysis date: 26.10.2016 Expiry Date: 09/2019 TEST NOMINAL RESULT Unidentified by-products, Not more than 0.2% (w/w) 0.05 % individually Total impurities, Not more than 1.0 % (w/w) 0.13 % Identified Total impurities, Not more than 0.5% (w/w) 0.10 % unidentified Not more than 1.0 % (w/w) 0.23 % Total impurities, Identified + unidentified Microbiol. purity Microbiological quality* Total aerobic microbial count (TAMC)* Total combined yeasts/moulds count (TYMC)* Specified microorganisms* *Note: Periodic testing, |. e. one batch per month. Content Pantoprazole content Content uniformity MIN MAX Uniformity of dosage units ‘Takeda GmbH Plant Oranienburg Lehnitestrage 70 - 98 16515 Oranienburg, Germany According to Ph. Eur. 2.6.12 and 2.6.13 Complies with Ph.Eur. 5.1.4: Nonaqueous preparations for oral administration Not more than 103 CFU/g Not more than 102 CFU/g Absence Escherichia coll (1.9) 20.0 mg/film-coated tablet + 5% (19.0 - 21.0 mg/film-coated tablet) According to Ph. Eur. 2.9.40 Level 1 (10 units) satisfy the acceptance value (AV) of no more than 15.0% or Level 2 (30 units) satisfy the acceptance value (AV) of no more than 15.0% and all individual values are between 0.75 « Mand 1.25 +M Not performed Not performed Not performed Not performed 20.1 mg/film-coated tbl. 96.9% 103.6 % Level I complies Cert of Analss TOB Version: 2 Report: $3977 Date: 15.11.2016/17:32:27 From: LIMSORAP Selte 2von 3Certi ate of Analysis Controloc 20 mg Gastro-resistant Tablets (ROU) Product specification Q00073412 Version 2.0 Tested according Batch no. 365170 Product code: 4054490 Manufacture Date: 30.09.2016 Bulk Product no. 6109959 Bulk Batch no.. 11255402 Analysis date: 26.10.2016 Expiry Date 09/2019 TEST NOMINAL RESULT AV value Max 15.0 % 4.6% Dissolution According to Ph. Eur. 2.9.3 Minimum value after 120 min Not more than 10 % 0% Maximum value after 120 min Not more than 10 % 0% Mean value after 120 min Not more than 10 % 0% Minimum value after 45 min Not less than 85 % 100 % Maximum value after 45 min Not less than 85 % 103 % Not less than 85 9% 101 % Mean value after 45 min Dissolution level Test for resistance to gastric juice Ph. Eur. acceptance table 2.9,3-3 (after 120 min), must be fulfilled. Test in pH 6.8 buffer Ph. Eur. acceptance table 2.9.3-4, Q= 80 % (after 45 min), must be fulfilled, Level 1 complies Manufactured according to the requirements of GMP and complies with the registered specification. Released by: Release date: Dr. Ulrike Schub Qualified Person 15.11.2016 This Is an electronic signature according to EU EudraLex Volume 4 Annex 11 and US Title 21 Code of Federal Regulations Part 11. ‘Takeda GmbH Plant Oranienbura Lehnitzstrae 70 - 98 16515 oranienburg, Germany Cer of Analysis TOB Version: 2 Report $2977 Date: 15.11.2016/17:32:27 From: LIMSORAP Selte 3 von 3