Indian pharmaceutical manufacturing company Shasun Chemicals and Drugs has now got its eye fully on the US market after recent approval of its new formulation facility in Puducherry.
The US Food and Drug Administration (FDA) approved the 100,000 sq ft. facility, which will handle oral solid dosages, and follows the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approval in October last year.
Speaking to in-PharmaTechnologist.com, Shasun whole time director Vimal Kumar said he viewed the approval as paving the way for a new business venture.
"The US market is very important. We believe we could get better value and better margins."
The company, which does contract manufacturing of finished dosage forms, active pharmaceutical ingredients (APIs) and intermediates, has signed up with Iceland-based Actavis and Indian firm Glenmark Pharmaceuticals with plans to manufacture more than 22 products at the Puducherry facility, which was completed last year.
The products, both generics and branded, are planned to be launched in the US by the second half of next year.
Kumar was pleased with the FDA inspection and approval, as the company, one of the largest suppliers of Ibuprofen, did not receive a Form 483.
A form 483 is the written report that the US regulator produces to reflect and identify a list of observations and deficiencies found during the inspection. Therefore, "no form 483 issued" meant that neither deficiencies nor observations had been detected at the facility.
The formulation facility, which includes features such as bar-code readers, metal detection and an automatic container cleaning system, will have an annual production capacity of more than 3 billion tablets, including film and sugar coated, and 120 million capsules (hard gelatine).
Shasun chief executive and managing director N Govindarajan said in a statement: "With the formulation facility having already undergone successful MHRA and now US FDA audit, we are in the process of diversifying our business by making a foray into formulation exports, predominantly into the regulated markets, namely USA, Canada and Europe."
Beside Ibuprofen, the company, founded in 1976, also manufactures anti-ulceratives
Nizatidine and Ranitidine.
Shasun has invested $25m (€18.3m) in a new site in the special economic zone at the Pharma-city, Vizag in Andhra Pradesh, India, to expand API production. The company is planning to build a multipurpose and multi-product facility on the purchased land by the end of 2008.
Meanwhile, the company also announced today its wholly-owned UK-subsidiary Shasun Pharma Solutions has entered into a non-exclusive licensing agreement with H Lundbeck, a research based Danish company engaged in finding new drugs for treatment of CNS (Central Nervous System) disorders.
Under the terms of the agreement, Shasun will grant Lundbeck the use of its proprietary Buchwald cross-coupling technology to manufacture and commercialize new APIs.