Zydus receives final approval from the USFDA for Pitavastatin Tablets

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States

Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg

Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)

Lupin receives EIR from USFDA for injectable facility in Nagpur

The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022

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)

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya

Aurobindo Pharma gets VAI classification from USFDA for Telangana plant

Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated

Lupin receives approval from USFDA for Glycopyrrolate Injection USP

The approval for Glycopyrrolate clears the path for more internally manufactured injectable products

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