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Results For "manufacturing-facility"

648 News Found

Indian API companies to grow by 7-8% and operating profit margin to improve to 12-14% in FY2025: ICRA
Opinion | August 14, 2024

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%
News | August 12, 2024

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
Drug Approval | August 11, 2024

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations


Zydus receives final approval from USFDA for Valbenazine Capsules
Drug Approval | August 11, 2024

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
Drug Approval | August 09, 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
News | August 07, 2024

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
Drug Approval | July 30, 2024

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


Zydus receives USFDA’s final approval for Valsartan Tablets
Drug Approval | July 24, 2024

Zydus receives USFDA’s final approval for Valsartan Tablets

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India


Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr
News | July 24, 2024

Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr

Reported profit after tax declined 19% year-on-year to Rs 76 crores


Briefs: Zydus Lifesciences and Divi's Laboratories
Drug Approval | July 22, 2024

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets