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

Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg

Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)

Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets

Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms

Zydus receives final approval from USFDA for Loperamide Hydrochloride Capsules

Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States

Briefs: Morepen Laboratories and Zydus Lifesciences

The company is addressing these observations

Zydus receives final approval from the USFDA for Hydrochlorothiazide Tablets

This combination medicine is used to treat high blood pressure (hypertension).

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.

USFDA completes regulatory inspection of Natco's Vizag formulation facility

At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults