Drug maker Granules India on Thursday said the US Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Application for Acetaminophen 650 mg tablets, extended release (ER).
A generic version of Tylenol 650 mg tablets, ER, Acetaminophen 650 mg ER tablets are used primarily for temporary pain management, including arthritis relief, the Hyderabad-based firm said. Granules India is the only supplier that is backward integrated up to the API (active pharmaceutical ingredient) on this product, the company claimed. “Our vertically integrated approach will enable us to provide a high-quality, cost-efficient product that benefit consumers,” said Krishna Prasad Chigurupati, chairman and managing director.
With a capacity of over 24,000 tonnes of Acetaminophen API and finished dosage capacity of more than 18 billion units, the company is confident of ensuring supply security to the customers. That, in turn, “will support us to capture our target market share,” he said.
