Biotech major Biocon has received its first generic formulation approval in Europe, paving the way for the company to launch Rosuvastatin calcium tablets in several European countries.
Biocon has received European approvals for Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic equivalent of Crestor tablets, indicated for hyperlipidemia or mixed dyslipidemia, the company said.
The generic formulations approval in the regulated markets marks an important milestone in Biocon’s small molecules strategy of forward integration from APIs (Active Pharmaceutical Ingredient) to finished dosages, it said today.
Biocon said the approval for Rosuvastatin Calcium, through decentralised procedure will open the doors for Biocon to over 15 European countries and will enable the company to address $1.2 billion opportunity, starting FY17.
The form said it was the first generic company to receive a Certificate of Suitability for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM).
CEP certification indicates that an API is suitable for use in medicinal products in the EU.
“This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries. We plan to collaborate with regional partners in the near—term to provide access to this affordable generic and thus help patients and governments to bring down their healthcare spends,” Biocon CMD Kiran Mazumdar—Shaw said.
Biocon in a statement said it aims to rev up its generic formulations business with a target of 20—25 filings over the next few years. Its new potent oral solid dosage formulations facility coming up in Bengaluru will enable this business expansion.
It is also working on dossiers to introduce these formulations in emerging markets where regulatory clearances are primarily based on approvals given by regulators in the US/EU, the statement added.