#1Hebei Bimeda Factory Introduction Global Excellence in Animal Health Bimeda#2414 Bimeda Group 8322#3Bimeda in Numbers 0 OPERATES IN OVER + $15 75 countries 00 D 00 6R&D and REGULATORY 7 LABS MANUFACTURING 9 facilities in COUNTRIES 7 COUN 60 中心 800+ EMPLOYEES 150in SALES AN MARKETING IIII YEARS SINCE FOUNDED IN IRELAND in 1960 *Source: Citibank report Bimeda $11 #17 IN THE WORLD sales* $*$200m revenue#4Bimeda's Global Presence Le Sueur, USA Cambridge, Canada Dublin, Ireland Denbigh, Wales Chicago, USA Irwindale, USA Texas, USA Registered products Sales and marketing R&D, manufacturing Bimeda Monte Mor, Brazil Dardilly, France Kenya Hebei, China 5#5Bimeda Brands MACROSYN DECT SPOT 10 mg/ml Buparvex Injection Bimoxyl LA Ectofly 1.25% w/v Pour On Solution for Sheep Bimectin (ivermectin) Bimectin Horse Oral Paste 18.7 mg/g Dermodoo® Skin healing foam Endospec 10% SC COSECURE™ FLEE PESTICIDE FREE 牙乐粉 VetO'Dent Cronyxin Injection Cyper Guard CONCENTRATE FOR DIP EMULSION NON Sheep Dip Bimeda SQ#6Bimeda OUR VISION OUR MISSION To be the partner of choice for optimizing the wellbeing of the world's animals As a family-owned company with over half a century's experience in improving global animal health, we are passionate about providing our customers with efficient science-driven solutions to continuously optimize the wellbeing of animals OUR VALUES Collaboration Accountability Learning Customer Focus Innovation Bimeda 7#7700 --** www Hebei Bimeda Factory#8Bimeda in China Beijing Bimeda Shijiazhuang Shanghai Hong Kong Office Number of staff Shanghai 4 Beijing 3 Shijiazhuang 56 Hong Kong 4 9#9Factory Overview Key Specifications Initial site surface 22,520m2 Sterile injectable filling in a grade B+A environment Automatic filling line Non-penicillin and non-hormone 1st Line, 10ml sterilisation 100ml, aseptic 2nd Line to be installed, 250ml to 500ml aseptic sterilisation Currently approved for China, East Africa, Australia & New Zealand Bimeda Blimeda 10#10Current 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#11Current Audit History 2020 CHINESE GMP AUSTRALIA GMP Australian Government Australian Pesticides and OFFICIAL: Sensitive Veterinary Medicines Authority 中华人民共和国 PEOPLE'S REPUBLIC OF CHINA Ret: M-7964 兽药GMP证书 CERTIFICATE OF GOOD MANUFACTURING PRACTICES FOR ANIMAL DRUGS 证书编号:(2020)兽药GMP证字03026号 CERTIFICATE NO : 企业名称:河北百美达医药科技有限公司 MANUFACTURER: HEBEI BIMEDA PHARMACEUTICAL TECHNOLOGY CO., LTD 生产地址:河北省石家庄经济技术开发区赣江路60号 ADDRESS: No. 60 GANJIANG ROAD, ECONOMIC-TECHNOLOGY DEVELOPMENT ZONE, SHIJIAZHUANG HEBEI PROVINCE 验收范围:非最终灭菌小容量注射剂/非最终灭菌大容量注射剂 SCOPE OF INSPECTION: 经审核,符合中华人民共和国《兽药生产质量管理规范》要求。 特发此证。 This is to certify that the above manufacturer complies with the requirements of Chinese Good Manufacturing Practices for Animal Drugs. 有效期:2020年12月8日至2025年12月7日 VALID: 8/12/2020/-7/12/2025/ 发证机关:河北省农业农村厅 ADMINISTRATIVE: 业务 发证日期: 2020年12月8日 ISSUED DATE:8/12/2020/ 行政审批专用章 Date Achieved: DEC 2020 30 June 2021 Mr Jeremy Li Plant Manager Hebei Bimeda Pharmaceutical Technology Co.,Ltd No. 60 Ganjiang Road, Economic Technology Development Zone Shijiazhuang, Hebei Province, CHINA Dear Mr Li, CONFIRMATION: OVERSEAS SITE GMP COMPLIANCE The APVMA is satisfied that this manufacturer meets the requirements for the manufacture of the products nominated in your most recent Pre-Audit Notification form (FM MOL45) dated 16 March 2021. The following site was last remotely inspected for GMP compliance by an APVMA-authorised auditor on 12-19 April 2021. Provided no further contrary evidence is received, the APVMA will recognise the GMP compliance of this site, for the steps and/or products specified, for a period of 30 months from the date of the last inspection. Therefore, provided no further contrary evidence is received, the following site will be recognised until 12 October 2023 for the following steps and product types: Manufacturing site name: Hebei Bimeda Pharmaceutical Technology Co.,Ltd Manufacturing site address: No. 60 Ganjiang Road, Economic - Technology Development Zone Shijiazhuang, Hebei Province, CHINA Date Achieved: APRIL 2021 Bimeda 12#12◉ Why Hebei Bimeda? Key Specifications State of the art sterile injectable facility ◉ Built to the exceptionally high standards of Bimeda's worldwide facilities Full control over testing/analysis through to production and labelling/release Competitive pricing Access to Rainbow Labs, our raw materials testing and innovation centre approved by the FDA Shijiazhuang is a major industrial city and the economic centre of Hebei Province. Nicknamed the "medicine hub of China", Shijiazhuang is home to major Chinese pharmaceutical companies and factories. The city is well connected with transport links to the Beijing-Guangzhou Railway and the new Beijing-Guangzhou-Shenzhen-Hong Kong High-Speed Railway Bimeda 13#13700 --** www Appendix#14Equipment Overview Batching Tanks The volume is 500, 1000 and 2500 cubic meters Vial Washing Machine and Tunnel Oven Bimeda 15#15Equipment Overview Bimeda S Filling Machine Capping Machine 16#16Equipment Overview MES 2000y Purified Water System The purified water is prepared by multi-medium filter, activated charcoal filter, softener, two-stage RO, EDI and distributed to storage tank and distribution system. Water for Injection System Purified water is the raw water for WFI system, goes through multi-efficiency distiller water machine into WFI storage tank. Purified water and WFI circulates all the time. Bimeda 17#17Equipment Overview Bimeda 49 HVAC System There are 13 HVAC systems in total. 9 for cleaning areas. 4 for unclassified areas. 18#18Bimeda 停车位 Parking P ②人流大门 停车位 Parking 17.00 6.70 工程補助楼 ( 二期) Service Building 污水调节池 10 Sewage adjust pool 消防通道 Fire Fighting Access QC区域(二楼), 防火箭 进货装卸区: Loading Area for In-coming Materials Site area: Construction area: Filing Line configuration: 5,594.91 m² 22,520 m² 10ml/20ml/30ml/50ml/100ml vial 19 56.70 制剂生产车间 FDF Workshop 制剂生产车间扩建(二期) FDF Workshop Reserved 雨水事故池 The rain accident pool Site Layout 预留车间(三期) Reserved Area for Future 12.83. Reservior for Production Living Water 1 动力车间 57.00 Power Utility Workshop /水池(预留) Pool Reserved 消防水池 56.70 田 甲类试剂库 溶剂库房 废品库房 Fire Fighting Water 消防通道士 Fire Fighting Access Turn-around Field 回转场地-#19Organisational Structure Plant Manager+ Production Manager+ Quality Manager+ Technology Manager Deputy Plant Manager I Sales Company- Purchase Company. Finance Department- Production Management Quality Management Department. Department Technology- Department HR EHS Department Department- QC Department+ QA Department- Department- Maintenance Department- Warehousing Planning & Production workshop. Bimeda 20#20Quality Management Systems HPLC mainly used for assay and related substances testing. IR spectrophotometer Bimeda Polarimeter and UV tester GC mainly used for residual solvent testing 21#21Quality Management Systems Isolator used for sterility testing Incubators Bimeda 22#22Rainbow Labs Overview Rainbow Labs JV created in 2011 ■ Raw materials testing and innovation centre Approved by European authorities Approved by FDA authorities Provides auditing services throughout China Bimeda 23#23WE LOOK FORWARD TO WORKING WITH YOU!