Our International Branded Generic product business focused on exports to emerging and semi-regulated international markets while expanding our business to regulated markets like the United Kingdom, and Canada. We had exported our branded generics to 17 countries and we have 200 active product registrations (and 20 registrations subject to renewal) with international authorities and 36 fresh registration applications in process with international authorities. We have a strong pipeline of over 126 in-process product dossiers for exports.
Our R&D team is working with our partner to develop drugs which we aim to submit to the concerned regulatory authority. In addition, in Canada, through the technology transfer route, we are looking to manufacture two products in solid dosage form.
In the United Kingdom, through technology transfer route, we are introducing three new products in both solid as well as dry powder injection dosage form for the UK market. We are currently developing six product formulations for the European market. We have completed a submission batch manufacturing (exhibit batch) to The European Medicines Agency (EMA) for two of these products.
We have received EU GMP approval for our Baddi, Unit 2, Block C alongwith WHO-GMP and other international registrations and accreditations.
| Accreditation Authority | Country | Status |
|---|---|---|
| Food, Medicine and Health Care Administration and Control Authority | Ethiopia | Audited |
| Tanzania Medicine and Medical Devices Authority | Tanzania | Renewal application made |
| National Drug Authority | Uganda | Audited |
| Medical Technology and Supplies (Drug Regulatory Authority) | Sri Lanka | Site Registered |