Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD).

The company said the US regulator has approved the sale of theophylline tablets in 300 mg and 450 mg doses.

It said the drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, Gujarat.

According to IQVIA MAT (moving annual total) data as of March 24, annual US sales of theophylline extended-release tablets, 300 mg and 450 mg were $12.6 million.

The company further said it now has 396 approvals and has filed over 460 abbreviated new drug applications (ANDAs) as of March 31 since the filing process began in FY 2003-04.