CNBCTV18

Cipla evaluating US FDA Form 483 observations on supply partner Pharmathen

Cipla clarified that its supply partner Pharmathen received nine USFDA Form 483 observations during a November 2025 ...

Cipla shares slide 4.5% after USFDA flags compliance gaps at key Lanreotide supplier site

Regulatory action at Pharmathen’s main manufacturing site in Greece could potentially disrupt supplies of one of Cipla’s ...
FiercePharma

FDA tells Dr. Reddy's in Form 483 to keep trying with API plant in Srikakulam

For the second time in about six weeks, India’s Dr. Reddy’s has been rebuffed by the FDA for its efforts to deal with the problems the agency had outlined in a warning letter two years ago. In a ...
NDTV Profit on MSN

Cipla Shares Fall 4% After USFDA Flags Compliance Issues At Pharmathen's Rodopi Facility

The form includes nine observations highlighting serious concerns over current Good Manufacturing Practices (cGMP).
Medical Dialogues

Cipla Partner Pharmathen Receives 9 USFDA Observations

Cipla had earlier received final USFDA approval in May 2024 to market its generic Lanreotide injection in multiple strengths.
PharmTech

The Value of FDA 483s and Warning Letters

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel. Q. We are a US-based start-up company, and we are ...
Becker's ASC

FDA Form 483 Outlines Conditions Observed at NECC

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...