Gland Pharma’s French Connection: Cenexi Facility Faces 11 ANSM Observations, But Production Keeps Pulsing

Source: Market Screener, The Economic

Gland Pharma Limited today said that its subsidiary, the Fontenay Manufacturing Facility in France belonging to Cenexi, received a final report from French drug regulator ANSM with 11 observations from a recent inspection. The company reiterated that the findings would not halt current manufacturing activities and reaffirmed its intention to address all regulatory concerns in a timely manner.

Meanwhile, Gland Pharma achieved a significant win with USFDA approval for its Angiotensin II Acetate Injection, strengthening its injectable portfolio worldwide.

Key Highlights

ANSM Inspection Result:

Agence nationale de sécurité du médicament et des produits de santé (ANSM) carried out a Good Manufacturing Practices (GMP) inspection of Cenexi's Fontenay site between December 9 and December 19, 2024. The June 3, 2025, final report had 11 observations, compared to the 10 observations in December 2024.

No Disruption to Operations:

Gland Pharma guaranteed investors that the operations of producing at the Fontenay plant will not be impacted. The company is closely collaborating with ANSM to resolve all the issues that the report detailed.

Proactive Compliance:

Cenexi, acquired by Gland Pharma last year, is closely collaborating with French regulators to resolve the observations and will continue reporting exchanges of progress.

USFDA Clearance:

In a welcome turn of events, Gland Pharma secured USFDA approval for its Angiotensin II Acetate Injection 2.5 mg/mL, which awarded it 180 days of generic drug exclusivity in the US market. The drug, employed in the rise in blood pressure in adults with septic or distributive shock, generated US sales of around $58 million for the twelve months ended March 2025.

Financial Performance:

Despite production issues at Cenexi in the short term, Gland Pharma registered 5% revenue growth (excluding Cenexi), and strong sales volumes in the US, Canada, Australia, and New Zealand were a key strong contributor to its overall growth. "Cenexi is looking forward to operating hand-in-hand with the ANSM with regard to the observations and will give further updates to the exchanges whenever available." – Official Gland Pharma statement.

Source: Gland Pharma Limited Regulatory Filings, Moneycontrol, Business Today, Angel One, Upstox