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Current Audit History AFRICA GMP ISO 9001:2015 306396 NATIONAL DRUG AUTHORITY CERTIFICATE OF COMPLIANCE WITH GOOD MANUFACTURING PRACTICE GUIDELINES THE NATIONAL DRUG POLICY AND AUTHORITY ACT, CAP 206 Issued under Regulation 19(5) of the National Drug Policy and Authority (Licensing) Regulations 2014 Certificate No. 048/GMP/2020 This is to certify that the drug manufacturing facility. Name of facility: Hebei Bimeda Pharmaceutical Technology Company Limited. Physical address of facility: No 60, Ganjiang Road Shijiazhuang Economic & Technological Development Zone - China License number of the manufacturer: Business Licence 911301000837838447 100201 Has been inspected by the Authority for compliance with the Good Manufacturing Practice Guidelines On the basis of the inspection carried out on 17th and 18th October 2019, it is certified that the facility indicated on this certificate complies with Good Manufacturing Practice for dosage forms listed in Table 1 below. Table 1: Approved lines No Dosage form Category 1 Smair Volume Parenterals- Liquid Injection Non-beta Lactam 2 Large Volume Parenterals Non-beta Lactam Liquid Injection Activities Manufacture of finished pharmaceutical (medicinal) product - Veterinary Manufacture of finished pharmaceutical (medicinal) product Vetennary The responsibility for the quality of the individual batches of the drugs manufactured through this process lies with the manufacturer This certificate remains valid until 18th October 2022. it becomes invalid if the activities or the categories certified change or if the facility is no longer considered to be in compliance with GMP Issue Date: 04 May 2020 CCCI QUALITY MANAGEMENT SYSTEM CERTIFICATE Registration No. UODG6200016BROS This is to certify that the quality management system of Hebei Bimeda Pharmaceutical Technology Company Limited. Es in conformity with ISO 9001:2015 This certificate is valid for the following scope: Manufacturing and sales of sterile injectable product (small and large volumes) The The certificate changed on June 23, 2021 This certificate is valid from June 10, 2020 to June 9, 2023 The applicability of the standard or detailed in the organization's Quality Manual. one which needs administrative pontation shall be in accordance with valid licens In the eps that the gation regularly realvos sulance assessments, the certificate shall be welid when used together with the Notice for Maintenance of Use of Certificates and Logos Information about the certificate can be queried on the official robarte of CNCA (www.cob.gov.m GALION China Certification Center, Inc. Tal Coran Zh the General Manager: Date of issue: June 10, 2020 Bimeda NATAL DRUG AUTHORITY NATIONAL Denis Mwigwa EOR THE AUTHORITY PLOT 19 LUMUMBA AVENUE PO BOX 23096, KAMPALA Date Achieved: SEPT. 2019 IAF UKAS 0066 Date Achieved: JUNE 2020 11

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