Tag: USFDA

USFDA clears Strides’ manufacturing unit in Bengaluru

August 20, 2026 admin

The FDA headquarters in the U.S. | Photo Credit: Getty Images Strides Pharma Science Limited on Thursday said its flagship manufacturing facility in Bengaluru has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), marking the successful closure of the regulatory inspection. The USFDA conducted a current Good Manufacturing Practices…

Business

Alembic Pharma gets USFDA nod for Travoprost glaucoma drug

December 19, 2025 admin

The U.S. FDA approval came for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution. File. | Photo Credit: Reuters Drugmaker Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004% (ionic buffered solution). The approved…

Business

U.S. faces shortage of IV fluids, India alerts domestic firms to chip in

October 30, 2024 admin

Image for representation purpose only. | Photo Credit: AP India’s drug exporters body Pharmexcil has alerted members to a shortage of intravenous (IV) fluids the U.S. is facing in the aftermath of Hurricane Helene damage to a facility and urged them to explore the opportunity to chip in with supplies. Manufacturers of intravenous fluids having…

Business

U.S. faces shortage of IV fluids, India alerts domestic firms to chip in

October 30, 2024 admin

Image for representation purpose only. | Photo Credit: AP India’s drug exporters body Pharmexcil has alerted members to a shortage of intravenous (IV) fluids that the United States is facing in the aftermath of Hurricane Helene damage to a manufacturing facility, and urged them to explore the opportunity to chip in with supplies. Manufacturers of…

Business

Why MDH, Everest spices are under international scrutiny | Explained

May 3, 2024 admin

The story so far: A crisis of confidence assails the Indian spice export industry. At least five countries — including Singapore, Hong Kong and the U.S. — have announced an investigation into possible contamination of spice mixes sold by top Indian brands, MDH and Everest. The complaints cite the presence of ethylene oxide, a toxic…

Business

The Hindu Morning Digest – April 28, 2024

April 28, 2024 admin

Centre releases disaster relief funds for Karnataka and Tamil Nadu The Union government has ordered the release of ₹3,730.32 crore towards “relief assistance for natural calamity” from the National Disaster Response Fund (NDRF) weeks after the governments of Tamil Nadu and Karnataka moved the Supreme Court seeking relief funds for calamities such as Cyclone Michaung,…

World

U.S. FDA issues warning letter to Natco over facility near Hyderabad

April 9, 2024 admin

Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest. | Photo Credit: Reuters The United States Food and Drug Administration (U.S. FDA) has issued a warning letter to Natco Pharma over quality…

Business

Official action indicated for Biocon arm’s unit in Malaysia after USFDA inspection

October 18, 2023 admin

Representational image only. | Photo Credit: The Hindu Biocon Limited on October 18 said the U.S. health regulator has classified as ‘official action indicated’ for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (Official Action Indicated) status may cause delay and/or withholding of pending product approvals…

World