Eris Lifesciences Receives ANVISA Approval for Sterile Injectable Facility, Enabling Brazil Market Entry

Key Insights

• Eris Lifesciences' sterile injectable manufacturing facility in Ahmedabad received approval from ANVISA, Brazil's national health regulatory agency, following a successful inspection in May 2025.
• The approval enables the Indian pharmaceutical company to enter Brazil, the largest pharmaceutical market in South America, expanding its Latin American presence.
• The facility is part of Swiss Parenterals subsidiary acquired by Eris in 2024 and is already EUGMP and PIC/s approved, supplying products to several Latin American markets.

Eris Lifesciences Limited, a leading Indian branded formulations company, announced that one of its sterile injectable manufacturing facilities in Ahmedabad has received approval from ANVISA, Brazil's national health regulatory agency. The approval follows a successful inspection conducted by the regulatory agency in May 2025 and enables the drugmaker to enter Brazil, the largest pharmaceutical market in South America.

Strategic Market Expansion

The approved facility is part of Swiss Parenterals, a subsidiary that was acquired by Eris in 2024. Both facilities operated by Swiss Parenterals are already EUGMP and PIC/s approved and currently supply a range of products to several Latin American markets including Mexico, Chile, Argentina and Peru. A company spokesperson indicated that the ANVISA approval would enable the company to launch its products in Brazil and achieve comprehensive coverage of the Latin American pharmaceutical market.

The company expects to receive approval for its second facility soon, following the inspection of both injectable facilities conducted by ANVISA in April 2025.

Leadership Commentary

Commenting on the development, Mr. Amit Bakshi, CMD of Eris, stated: "We take this approval as yet another endorsement of our operating and quality standards in life-saving dosage forms like injectables. This approval takes us a step forward in our strategic transformation into a company with increasing focus and leadership in complex injectables and biotechnology. We made major investments to initiate this transformation last year and we are glad to note that we have made significant progress in creating value from these investments with many more exciting developments expected in the quarters to come."

Market Response

Following the announcement, shares of Eris Lifesciences Limited were trading 0.2 percent higher at Rs 1,772.50 on the BSE. The stock had previously closed at Rs 1,768.90, with the total number of shares traded during the day reaching 5,572 across over 720 trades. The stock hit an intraday high of Rs 1,816.95 and an intraday low of Rs 1,728.90, with a net turnover of Rs 9,860,209.00 during the trading session.