Indoco Remedies gains nearly 2% on USFDA nod for neuropathic pain treatment tablets

In an exchange filing on Tuesday, the pharma company said that it has received final approval from the US drug regulator for its abbreviated new drug application (ANDA) for Pregabalin capsules in various strengths of 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg.

The drug is a generic equivalent of the Reference Listed Drug, Lyrica Capsules. These capsules will be manufactured at Indoco Remedies’ manufacturing facility in Goa, the company informed the stock exchanges.

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

Indoco Remedies shares opened at ₹319.95 apiece and rallied as much as 1.72% to hit an intraday high of ₹320.5 apiece on the NSE. However, the pharma stock pared some of early gains and closed 0.52% lower at ₹313.40 apiece on the NSE.

Last week, in another exchange filing on May 16, Indoco Remedies informed the bourses that the USFDA concluded inspection at the company’s API Kilo Lab manufacturing facility in Navi Mumbai, and the Indoco Analytical Solutions division. The inspection concluded with zero observations.

Indoco Remedies is a fully integrated pharmaceutical company that develops and manufactures pharmaceutical products for both Indian and international markets. The company operates 11 manufacturing facilities, out of which seven are dedicated to Finished Dosage Forms (FDFs) and four to Active Pharmaceutical Ingredients (APIs).