Wanbury receives EIR from FDA for Patalganga facility

USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India

ANVISA completes inspection at Caplin Steriles' facility at Gummidipoondi

Indian API companies to grow by 7-8% and operating profit margin to improve to 12-14% in FY2025: ICRA

Capital expenditure expected to moderate to Rs. 5.6 billion in FY2025 from an estimated Rs. 7.6 billion in FY2024

Wockhardt Q1 FY25 revenue up 14%

EBITDA for Q1 FY25 is at Rs. 100 crore compared to Rs. 32 crore in the previous year

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations

Zydus receives final approval from USFDA for Valbenazine Capsules

Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)

Atul Bioscience received EIR from USFDA for Ambernath facility

The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations

Lonza upgrades clinical manufacturing services at Bend site to include bottling and labeling capabilities

Lonza Bend (US) upgrades capabilities in early phase clinical manufacturing services with the addition of bottling and labeling equipment

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance