APEX HEALTHCARE BERHAD (COMPANY NO T)

Transcription

1 1. Introduction The Board of Directors of Apex Healthcare Berhad ( AHB or the Company ) is pleased to announce that its wholly-owned subsidiary, Xepa-Soul Pattinson (Malaysia) Sdn Bhd ( Xepa ), has been awarded a Certificate Of GMP Compliance Of A Manufacturer ( EU GMP Certificate or the Award ) for its manufacturing site located at Lot 1-5, Jalan TTC 1, Cheng Industrial Estate, Melaka, Malaysia, by OGYÉI, the National Institute of Pharmacy and Nutrition Hungary, on behalf of the European Medicines Agency. The EU GMP Certificate attests that Xepa is in compliance with the principles and guidelines of Good Manufacturing Practice as laid down in Directive 2003/94/EC of the European Commission. The EU GMP Certificate is dated 1 st September 2017 and received on 4 th September Background The regulatory control of pharmaceutical products in Malaysia is the responsibility of the National Pharmaceutical Regulatory Agency ( NPRA ) under the Pharmaceutical Services Division of the Ministry of Health. Malaysia is a member of the Pharmaceutical Inspection Co-operation Scheme ( PIC/S ), a co-operative arrangement between 49 Regulatory Authorities globally in the field of GMP of medicinal products for human or veterinary use. As a manufacturer based in Malaysia, Xepa comes under the regulatory ambit of the NPRA and conforms to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products. In addition, Xepa s production and laboratory facilities are certified for conformance with ISO 17025, ISO 9001:2015 and ISO In Xepa s quest to capitalize on opportunities to enter European and other developed markets, additional certification by the European Medicines Agency ( EMA ) is mandatory and was therefore actively pursued. 1

2 3. Information on European Medicines Agency The European Medicines Agency ( EMA ) works closely with the national competent authorities of the Member States of the European Union ( EU ) and the European Economic Area ( EEA ). EMA operates at the heart of the European medicines regulatory network, and is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. EMA protects public and animal health in all EU Member States, as well as the countries of the EEA, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at the EU level. Any manufacturer of medicines intended for the EU market, no matter where the manufacturing facilities are located, must comply with all applicable principles and guidelines of Good Manufacturing Practices laid down by the EMA. 4. Information on Xepa Xepa is a leading manufacturer of off-patent pharmaceuticals in Malaysia. Xepa s product portfolio encompasses tablets, capsules, oral liquids, creams, ointments and sterile eye drops for use by healthcare professionals and consumers to treat conditions in a wide range of disease groups. Xepa is a key wholly-owned subsidiary of AHB. 5. The EU GMP Certificate The inspection of Xepa s manufacturing site was conducted on 7th July 2017 by GMP inspectors from the National Institute of Pharmacy and Nutrition, OGYÉI, which is the national competent authority of Hungary on behalf of the EMA. The EU GMP Certificate was awarded to Xepa on 1st September 2017 for Manufacturing Operations of human medicinal products. The scope, as extracted from the certificate, is as follows: 2

3 1 MANUFACTURING OPERATIONS 1.1 Sterile products Aseptically prepared (processing operations for the following dosage forms) Small volume liquids 1.2 Non-sterile products Non-sterile products (processing operations for the following dosage forms) Capsules, hard shell Liquids for internal use Other solid dosage forms: Powder for oral suspension(en) Semi-solids Tablets 1.5 Packaging Primary Packing Capsules, hard shell Liquids for internal use Other solid dosage forms: Powder for oral suspension(en) Semi-solids Tablets Secondary packing 1.6 Quality control testing Microbiological: sterility Microbiological: non-sterility Chemical/Physical Clarifying remarks (for public users): Sterile products - Small volume liquids: Eye drops only The Award attests that Xepa complies with the principles and guidelines of GMP laid down in Directive 2003/94/EC and is valid for a period of three years. 3

4 6. Implications of the Award The EU GMP Certificate enables Xepa to pursue contract manufacturing opportunities in the European market for tablets, capsules, liquids, oral suspensions and eye drops. It further opens new options for Xepa to register Xepa branded generic pharmaceuticals for marketing and sales into member countries of the European Union, while strengthening the standing of Xepa as a manufacturer of choice in its existing markets. The Board of Directors is of the opinion that EU GMP certification is a key milestone in Xepa s strategy for sustainable long-term growth. 7. Financial Effects of the Award 7.1 Share Capital The Award will not have any effect on the share capital of the Company. 7.2 Substantial Shareholders Shareholdings The Award will not have any effect on the substantial shareholders shareholdings of the Company. 7.3 Net Assets Per Share and Gearing The Award will not have any material effect on the net assets per share and gearing of the Company for the financial year ending 31 December Earnings Per Share The Award is not expected to have any material effect on the earnings per share of the Company for the financial year ending 31 December

5 8. Interest of Directors, Major Shareholders and/or persons connected with them None of the Directors and/or major shareholders of the company and/or persons connected with them have any interest, direct or indirect, in the Award. This announcement is dated 6th September