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Indoco Remedies gets USFDA’s final approval for Pregabalin capsules

22 May 2024 Evaluate

Indoco Remedies has received final approval from the US Food and Drug Administration (USFDA) 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 300 mg, of Upjohn US 2 LLC. 

This product, Pregabalin capsules will be manufactured by Indoco Remedies, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India. Pregabalin is used for Neuropathic pain associated with diabetic peripheral neuropathy and spinal cord injury, Postherpetic neuralgia and Fibromyalgia.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.


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