Indoco Remedies Receives US FDA Final Approval for Pregabalin Capsules

Indoco Remedies Receives US FDA Final Approval for Pregabalin Capsules

By, Admin 22 May 2024

Overview

Indoco Remedies Ltd., a fully integrated, research-oriented pharmaceutical company, announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for pregabalin capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg. This is a generic equivalent of the Reference Listed Drug, Lyrica capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg, of Upjohn US 2 LLC.

Manufacturing Facility

This product, pregabalin capsules will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.

Pregabalin: Indication

Pregabalin is used for neuropathic pain associated with diabetic peripheral neuropathy and spinal cord injury, postherpetic neuralgia and fibromyalgia.

Words from Managing Director: Indoco Remedies

Commenting on the achievement, Aditi Panandikar, managing director 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.”

Indoco Remedies

  • Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. 
  • The company’s turnover is US$ 212 million with a human capital of over 6,000 employees, including over 400 skilled scientists and field staff who are the strength of the organization.

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