Aurobindo Pharma Share Price in Focus; Receives Final USFDA Approval for Perampanel Tablets

Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) for Perampanel Tablets in six strengths: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg. The company announced the approval on October 3, 2026. 

Product Details 

The tablets are bioequivalent and therapeutically equivalent to Fycompa Tablets, the reference listed drug (RLD) of Catalyst Pharmaceuticals, Inc. The approval covers the manufacture and marketing of all six strengths in the US.  

Manufacturing and Launch 

Perampanel Tablets will be manufactured at Unit-IV of APL Healthcare, which is a wholly-owned subsidiary of Aurobindo Pharma. The company has said that the product will be launched in the third quarter of FY27.  

US Market Size 

According to IQVIA MAT data cited in the company’s release, the US market for the approved product was estimated at US$67 million for the 12 months ended August 2026. The company has not given a sales estimate for the product.  

USFDA ANDA Count 

With the latest approval, Aurobindo Pharma’s total USFDA ANDA approvals have reached 599. This includes 574 final approvals and 25 tentative approvals, as stated in the company’s filing. 

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Indications for Perampanel 

Perampanel Tablets are indicated for treating partial-onset seizures, with or without secondarily generalised seizures, in epilepsy patients aged four years and above.  

They are also indicated as adjunctive therapy for primary generalised tonic-clonic seizures in patients aged 12 years and above.  

Aurobindo Pharma Overview 

Aurobindo Pharma is headquartered in Hyderabad and operates across generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.  

Its products are sold in more than 150 countries, with 30+ manufacturing and packaging facilities approved by regulatory agencies including the USFDA, UK MHRA, Japan PMDA and WHO. 

Read More: Bank of Baroda Receives PFRDA Approval to Enter Pension Fund Business! 

Aurobindo Pharma Share Price Performance  

As of October 5, 2026, 12:08 pm, Aurobindo Pharma share price was trading at ₹1,670.70, a 0.36% decrease from the previous closing price. 

Conclusion 

The USFDA approval covers six strengths of Perampanel Tablets, with manufacturing planned at APL Healthcare’s Unit-IV. The product is scheduled for launch in Q3FY27. 

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