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Informist, Thursday, Nov. 6, 2025

 

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--Aurobindo Pharma: Eye INR 4 bln/yr revenue from India generics in near term
--Aurobindo Pharma: Don't plan to be aggressive in India generics market
--Aurobindo Pharma: Govt still reviewing minimum import price of penicillin G
--Aurobindo Pharma: Arm CuraTeQ to appy for US FDA OK for tocilizumab
--Aurobindo Pharma: Do not expect large capex spend in near term
--Aurobindo Pharma: Saw minimal sales of Revlimid in Q2, expect none in Q3
--Aurobindo Pharma: Expect break-even for China plant in Q3 or Q4
--Aurobindo Pharma: Injectable pdts in US facing single-digit price erosion
--Aurobindo Pharma: Ramping up Kakinada Pen-G plant production
--Aurobindo Pharma: See Eugia unit-III reinspection within 8 months
--CONTEXT: Comments by Aurobindo Pharma's mgmt in post-earnings analyst call
--Aurobindo Pharma: US FDA approved arm Eugia unit-III reinspection plea
 

 

By Narayana Krishna and Afra Abubacker

                       

HYDERABAD/NEW DELHI – Aurobindo Pharma Ltd. on Thursday said its injectable business arm Eugia Pharma Specialties Ltd. has received a confirmation from the US Food and Drug Administration for the re-inspection of its unit-III located near Hyderabad. The fresh audit of the plant may take place anytime within eight months from now, the company's management said in a post-earnings conference call.

 

"Going forward .., what we are looking at is (to be) number one on the injectable side. We have some interesting products. And hopefully, like, once Eugia-III gets the re-inspection and approvals, we have multiple products to launch," Aurobindo Pharma's management said.

 

Eugia Pharma exclusively makes high-value specialty injectable products. The company's key plant, Unit-III, received a warning letter from the US FDA along with the 'Official Action Indicated' tag. Though the company has not stopped production at the plant, new product approvals were stalled due to regulatory issues. The management said once this hurdle is cleared, the company has interesting products lined up for the US launch.

 

On Wednesday, Aurobindo Pharma reported a consolidated revenue of INR 82.86 billion for the September quarter, up over 6% on year and just over 5% from the trailing quarter. The revenue is slightly higher than analysts' estimate of INR 81.03 billion. The bottom line rose nearly 4% on year and 3% on quarter to INR 8.48 billion, but lower than the consensus estimate of INR 8.97 billion. 

 

Aurobindo Pharma said the majority of new launches expected in the injectables category are broadly tied up with the Eugia-III plant's FDA clearance. The company said oral solid products, mainly related to the oncology segment, were made in Eugia-I plant and there is no issue with launches in that category.

 

The company said products mainly in the injectables category are facing single-digit price erosion in the US. The company said sales of the generic cancer drug Revlimid were minimal in the September quarter and it is expecting almost nil sales of the drug in the October quarter.

 

The company's revenue from US formulations increased over 3% on year to INR 36.38 billion during the reporting quarter and the segment accounted for 43.9% of the overall consolidated revenue. It launched six products during the three-month period and received final approvals for seven abbreviated new drug applications.

 

On the Kakinada Penicillin-G facility, Aurobindo Pharma said the plant is presently running at 40-50?pacity and it is in the process of ramping up the production going forward. Aurobindo Pharma is waiting for the policy announcement from the Indian government on the minimum import price of Penicillin-G. Aurobindo Pharma's Kakinada plant was built under the Production Linked Incentive Scheme. The government is considering a pricing policy to protect these units from cheaper imports, which the company said, is under review. Aurobindo Pharma said once the policy is in place, the volumes from the Penicillin-G unit will go up and contribute significantly to the revenue as well as margins, the company said.

 

Aurobindo Pharma's management said as of the September quarter, the China plant had incurred a loss of a million dollars. But the company will be able to achieve break-even in Oct-Mar, the management said.

 

Aurobindo Pharma's biologics arm CuraTeQ Biologics Ltd. is expected to file a new drug application with the US FDA for its auto-immune drug Tocilizumab next year.

 

"We will start engaging with the US FDA to discuss about the possibility of a phase-three clinical study waiver for Tocilizumab. So, Tocilizumab, I haven't talked about this product before, but now this comes into the filing domain in the next year from us," the management said.

 

On India generics, the company said it has no plans to be aggressive. At present, the revenue from Indian generics was around INR 3 billion and the company is expecting it to be around INR 4 billion in the near term. The company is also not looking for big buyouts, but it may consider if any small size opportunities come across to add to the growth of Indian generics. Apart from India, the company would consider acquisition opportunities without looking at the size, but it would need to be the right fit.

 

On the capital expenditure side, the company is not planning any large spending or taking any new greenfield projects in the near term, the management said. For the September quarter, the company incurred a capital expenditure of $106 million. However, there will be some spending on some milestone payments, like setting up a warehouse in the US, and some on biosimilar.

 

At 1043 IST,  Aurobindo Pharma's shares traded at INR 1,122.30 on the National Stock Exchange, down 2.22% from its previous close.  End

 

US$1 = INR 88.60

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Tanima Banerjee

 

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