Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme. The FDA has slapped a warning letter on Sanofi’s Genzyme facility in ...
French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham.
The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and inadequate quality controls. The agency demands a comprehensive review, ...
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
Also Read: Sanofi’s Blood Cancer Drug’s New Subcutaneous Formulation ... The FDA also found Genzyme’s proposed corrective and preventive actions (CAPAs) insufficient. Sanofi must respond ...
Genzyme Corp. (Sanofi Genzyme) has disclosed sodium-dependent neutral amino acid transporter B(0)AT1 (SLC6A19) inhibitors reported to be useful for the treatment of phenylketonuria, among others.
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts.
Sanofi said on Thursday it would buy back 5 billion euros ($5.21 billion) in shares this year and could be more active with acquisitions in the near term as the drugmaker moves towards selling a large ...
French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following ... when it bought Massachusetts-based Genzyme in a deal worth over $20 ...
23—THURSDAY, Jan. 23, 2025 (HealthDay News) — The U.S. Food and Drug ... Genzyme manufacturing plant in Framingham, Massachusetts. On Jan. 15, 2025, a warning letter was sent to Sanofi stating ...