Natco Pharma’s active pharmaceutical ingredients unit in Chennai has received seven observations from the U.S. Food and Drug Administration.

The U.S. FDA had conducted an inspection at the API manufacturing plant in Manali, Chennai, from November 17-21. On conclusion, of the inspection, the company received seven observations in the Form-483, the generic drugmaker said on Friday (November 21, 2025).

The company believes the observations are procedural in nature and is confident to address them comprehensively, Natco Pharma said, reaffirming commitment to being cGMP compliant and supplying high-quality products.

Natco Pharma has launched Bosentan tablets for oral suspension, 32mg, a generic version of Actelion Pharmaceuticals’ Tracleer in the U.S.

It holds the first-to-file status for this product and will have 180-day generic drug exclusivity, Natco said on Wednesday (August 20, 2025. Lupin is its marketing partner for the product.

Bosentan TFOS, 32mg, had estimated sales of $10 million in the U.S. for 12 months ending June’25, the Hyderabad-based company said citing industry sales data. The drug is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in paediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.

Generic drugmaker Natco Pharma reported consolidated net profit for the June quarter declined more than 28% to ₹480.3 crore compared to ₹668.5 crore a year earlier amid pricing pressure in the key U.S. market and higher research and development expenditure.

The lower net profit came on a total revenue that dipped 1.42% to ₹1,390.6 crore (₹1,410.7 crore). During the quarter the business faced pricing pressure in the U.S. product portfolio and the company incurred increased R&D expenses on account of high value projects, Natco Pharma said.

₹2 interim dividend

The company has declared an interim dividend of ₹2 per equity share (of ₹2 each) for the first quarter.

Segmental revenue breakup showed formulations export declined, in the first quarter, to ₹1,126.5 crore (₹1,210.1 crore). Revenue from active pharmaceutical ingredients (API) increased to ₹52.6 crore (₹39.2 crore), while that from domestic formulations to ₹107 crore (₹102.2 crore). Crop Health Sciences revenue increased to ₹34.7 crore (₹15.6 crore).

Natco Pharma has made an offer to acquire nearly 36% stake in South African pharmaceutical company Adcock Ingram Holdings (AIHL) for $226 million (around ₹2,000 crore).

The proposal to acquire the stake from minority shareholders in an all cash deal is a strategic investment aimed at to expanding geographic footprint in South Africa, Natco said on Wednesday. Founded in 1890, AIHL has a diverse product portfolio, from generic and branded formulations, critical-care hospital products to consumer and home-care products. It operates across four segments -prescription, consumer, OTC and hospitals.

The acquisition is expected to be completed by 2025. Post-acquisition, AIHL will continue to operate as a private South African business with Bidvest holding 64.25% and Natco 35.75%, including a prior held 0.80% stake, in the company. Post-transaction, Natco will consolidate 35.75% of AIHL net profits in its financial results. AIHL clocked revenue of $536 million in the financial year June 2024 and profit after tax of $45 million.

“Adcock Ingram is a respectable pharmaceutical company with well-recognised brands and products and maintains a leading position in the South African pharmaceutical market. The proposed transaction will provide Natco Pharma with a well-established entry into the Southern African market. It will also allow us to tap into new revenue streams and expand our footprint in one of the largest and growing emerging markets, while providing a gateway to the African continent,” CEO and Vice-Chairman Rajeev Nannapaneni said.

Besides the acquisition, Natco Pharma Board also approved a proposal to incorporate a wholly owned subsidiary in South Africa with an investment of up to Rs.2,100 crore by this year to enter new geographies for growth and increased profitability. It also approved a proposal to liquidate wholly owned subsidiary Time Cap Overseas (TCOL), and directly hold the investment in step down subsidiary NatcoFarma do Brasil.

Natco shares closed 2.01% higher at ₹1,034.75 apiece on the BSE.