News about "US Food and Drug Administration (US FDA) "

Ipca Labs Receives US FDA Form 483 with Three Observations after Tarapur Facility Inspection

The US Food and Drug Administration (US FDA) has completed an inspection of Ipca Laboratories' Active Pharmaceutical Ingredients (APIs) manufacturing plant in Tarapur, Palghar (Maharashtra).

US Food And Drug Administration (US FDA) | 06/12/2025 | By Dineshwori

Biomoneta's Avata Rx Becomes First Indian Air-Decontamination Technology to Receive US FDA Approval

Biomoneta, a pioneering Indian healthtech company backed by Beyond Next Ventures India (BNV India), has secured approval from the US Food and Drug Administration (US FDA) for its flagship air-decontamination system, Avata Rx. This marks the first time an Indian company has received FDA clearance in the air-decontamination category.

US Food And Drug Administration (US FDA) | 03/12/2025 | By Dineshwori

Glenmark's Aurangabad Facility Clears US FDA Inspection With Zero Observations

Glenmark Pharmaceuticals announced that the US Food and Drug Administration (US FDA) has successfully completed a pre-approval inspection of its formulations manufacturing facility in Chhatrapati Sambhajinagar (Aurangabad).

US Food And Drug Administration (US FDA) | 01/12/2025 | By Dineshwori

Biocon Pharma Receives US FDA Nod for Tofacitinib Extended-Release Tablets

Biocon Pharma has received approval from the US Food and Drug Administration (US FDA) for its ANDA for tofacitinib extended-release tablets, securing final approval for the 11 mg strength and tentative approval for the 22 mg strength.

US Food And Drug Administration (US FDA) | 19/11/2025 | By Dineshwori |  100

Lupin Launches Risperidone Extended-Release Injectable with 180-day CGT Exclusivity in the US

Risperidone Long-Acting Injectable is Lupin’s first product using its proprietary PrecisionSphere technology developed by its subsidiary Nanomi.

US Food And Drug Administration (US FDA) | 14/11/2025 | By Dineshwori |  114

Lupin Launches Strategic Partnership Programme to Expand Reach of PrecisionSphere

Global pharma major Lupin has launched a strategic partnership programme aimed at expanding the reach of PrecisionSphere – the long-acting injectable (LAI) platform developed by its subsidiary, Nanomi.

US Food And Drug Administration (US FDA) | 09/10/2025 | By Dineshwori |  105

Biocon and Carnegie Secure Tentative FDA Approval for Rifaximin Tablets

Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., in partnership with Carnegie Pharmaceuticals, has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.

US Food And Drug Administration (US FDA) | 07/10/2025 | By Dineshwori |  198

Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities

Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat.

US Food And Drug Administration (US FDA) | 15/09/2025 | By Dineshwori |  271

Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities

Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat.

US Food And Drug Administration (US FDA) | 15/09/2025 | By Dineshwori |  271