Aurobindo Pharma receives 10 observations for Unit IX

The company had responded to the agency and carried out the required corrective actions.

Aurobindo Pharma Q2 FY23 revenue down 3.4%

Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore

USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility

The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue

Casper Pharma receives EIR from USFDA for its PAI

The inspection concluded with no observation (FDA-483) issued.

Lupin gets EIR from USFDA for its Ankleshwar facility

The inspection of the facility was conducted from August 16-19, 2022.

Lupin launches Sildenafil for Oral Suspension in US

Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US

Cipla receives EIR for Indore plant, Aurbindo for Raleigh

The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)

Zenara Pharma launches the first generic of Paxlovid for COVID-19 in India

Pfizer’s Paxlovid is approved by US FDA for COVID treatment

Granules India receives ANDA approval for Loperamide Hydrochloride and Simethicone Tablets

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

The unit has filed 2 Derma products and 1 MDI product.