Briefs: Ipca Laboratories, Lupin and Zydus

The company has extended its full co-operation and support to the officials of the Income Tax Department

Lupin receives USFDA approval from Obeticholic Acid Tablets

Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).

Concept Medical gets 4th IDE approval from USFDA

For the treatment of Superficial Femoral Artery

Agilent to appeal patent office decision on CRISPR gRNA patents

Agilent respectfully disagrees with the PTAB’s opinion of unpatentability in view of prior art previously considered by the USPTO during its primary examination

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations

Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007

APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram

Evonik starts construction of new U.S. facility for pharmaceutical lipids

Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness