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Chennai-based Shasun Pharmaceuticals on Tuesday announced the successful completion of factory inspections by officials from the US and Mexico, sending its scrip to its 52-week high of ₹196.7 intra-day on the BSE. However, the stock pared most of its gains to settle at ₹172.75, up 2 per cent.
Drug inspectors from the US Food and Drug Administration and Mexico’s COFEPRIS conducted safety audits at Shasun’s Cuddalore, Tamil Nadu, factory in June, the company said in a statement to the stock exchanges on Tuesday.
Good practice certificate The USFDA found Shasun compliant with regulations but recorded deviations from standard practices. A top official at Shasun told BusinessLine Form 483 contains inspection observations that are minor, and the company will carry out corrective actions. The Mexican regulator has said a Good Manufacturing Practice certificate will be issued soon.
Avinash Lodha, Associate Director at India Ratings and Research, a Fitch company, said the market for pain-killers is growing in the US. With no adverse report in the factory check, Shasun can look forward to steady supply to the US, provided it complies with the Form 483 observations, he said.
A large manufacturer of Active Pharmaceutical Ingredients, Shasun’s prospects brighten with this factory check as it is betting big on the US market. The company supplies drug intermediates to players in the $70-80 billion generics market in the US, and has plans to introduce its own branded formulations in the US through a partner soon, according to Managing Director S Abhaya Kumar.
“By FY15, we will see revenues of ₹300 crore accruing from sales of branded formulations in the US,” he told BusinessLine over a phone interview, adding that offbeat markets in South America and Japan are also targets.
The company extended the reach of its Ibuprofen market by acquiring global rights of a derivative of the pain-killer from the US company ScolrPharma. The move marks the beginning of a series of measures to deepen its presence in the market for non-steroidal anti-inflammatory drugs, Abhaya Kumar had said in a press release.
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