The decision – announced to the Bombay Stock Exchange this week – covers Claris’ second production facility at the site, which the UK Medicines and Healthcare products Regulatory Agency (MHRA) deemed to be in compliance with EU GMP rules.
The facility – known as Plant 2 – makes sterile liquid pharmaceutical products that are packaged in glass ampoules.
Claris said that MHRA approval will help to grow its injectables business – which saw revenue grow 30% last year - in the lucrative, but strictly regulated European market.
The firm also signalled its intention to install a second manufacturing line at Plant 2, explaining that the addition will allow it to make lyophilised drug products on a commercial scale when operational at the end of the year.
News of the regulatory thumbs up was accompanied by a 3.2% increase in the firms share price on the BSE earlier today.
The UK regulator's positive decision follows just under months after the US Food and Drug Administration (FDA) re-approved Claris’ neighbouring active pharmaceutical ingredient (API) and finished dosage form plant in Ahmedabad.
The facility, which was visited by the US regulator last October, also makes iron sucrose and hydroxyethyl starch (HES) for drug formulations.
Results down on infusion JV
The positive MHRA news contrasted with the financial results the Indian drugmaker unveiled last week, which showed that revenue fell 25% to INR1.5bn ($25m) and net profit declined just under 1% to INR154m.
However, according to Claris, the decline was largely due to the effect of the transfer of two of its infusion business to a joint venture formed with Japanese drug companies Otsuka Pharmaceutical and Mitsui & Co in August last year.
Under the deal Claris – which is a portfolio company of the Carlyle Group – holds a 20% stake in the joint venture with Mitsui holding another 20% and Otsuka controlling the remaining 60%.