Indoco Remedies Receives FDA Nod for Pregabalin Capsules

On May 21, 2024, Indoco Remedies informed the exchanges that the company got final approval from the U.S. Food and Drug Administration (US FDA) for Abbreviated New Drug Application (ANDA) for Pregabalin capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg.

The company stated that the Pregabalin capsules are a generic equivalent of the Reference Listed Drug, Lyrica® Capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300 mg, of Upjohn US 2 LLC.

Pregabalin is used for Neuropathic pain associated with diabetic peripheral neuropathy and spinal cord injury, Postherpetic neuralgia and Fibromyalgia.

Indoco Remedies Limited will manufacture pregabalin capsules at its facility located at L-14, Verna Industrial Area, Verna, Goa, India.

Sharing her thoughts on this achievement, the Managing Director of Indoco Remedies, Ms Aditi Panandikar, said, “This development marks a significant milestone for us and is a testament to our commitment to quality and regulatory compliance. We remain focused on quality, excellence and delivering value to our stakeholders.”

Earlier this month, the United States Food and Drug Administration successfully completed the inspection of the company’s API Kilo Lab manufacturing unit located at Rabale, Navi Mumbai and Indoco Analytical Solutions (IAS) division. The inspection ended with zero Form 483 observations, showcasing the company’s commitment to maintaining the highest quality and compliance standards.

In Q4 FY 2024, Indoco Remedies Limited reported a total income of ₹449.54 crore, which is ~5.04% higher compared to the same period in FY 2023. In the same quarter, the company’s net profit was ₹37.56 crore. In FY 2024, the company’s total income was ₹1,799.32 crore, and net profit was ₹116.64 crore.

In March 2024, Indoco Remedies Limited’s wholly owned subsidiary, Warren Remedies Private Limited, started commercial production from its Greenfield manufacturing facility located at Aurangabad, Maharashtra, to manufacture Oral Care Products and Pharmaceutical Intermediates and Active Pharmaceutical Ingredients (APIs).

On May 22, 2024, the share price of Indoco Remedies Ltd opened at ₹319.95, touching the day’s high at ₹320.50, as of 10:09 AM on the NSE.

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