Archive · 5 Jun 2025
Gland Pharma: USFDA Approval & French Regulator's Observations
Gland Pharma had a couple of news items.
Its subsidiary in France got a report from the French drug regulator with 11 issues to fix, but this won't stop them from making medicine.
Also, Gland Pharma got permission from the US to sell a medicine to help people with dangerously low blood pressure.
This new medicine is a generic version of an existing drug and will have exclusive rights for 180 days.
Gland Pharma's subsidiary, Cenexi, received 11 observations from the French drug regulator ANSM.
The observations relate to Good Manufacturing Practices (GMP) at the Fontenay facility.
Cenexi has submitted a corrective action plan and the observations will not disrupt manufacturing.
Gland Pharma received USFDA approval for Angiotensin II Acetate injection, 2.5 mg/mL.
The approved drug is for treating blood pressure in adults with septic or other distributive shock.
- Who
- Gland Pharma and its subsidiary Cenexi, ANSM and USFDA
- What
- Gland Pharma's subsidiary received observations from French regulator, and the company received USFDA approval.
- When
- June 4, 2024, inspection conducted in December 2024
- Where
- Fontenay manufacturing facility in France and US market
- Why
- The inspection was related to Good Manufacturing Practices (GMP) compliance and approval for a drug to treat blood pressure.
- Observations from ANSM
- 11
- Inspection Date
- December 9-19, 2024
- Drug Approved
- Angiotensin II Acetate injection, 2.5 mg/mL
- Drug Indication
- Treatment for blood pressure in adults
- US Market Value (Angiotensin II Acetate Injection)
- $58 million
- Generic Drug Exclusivity
- 180 days
