usfda

Aurobindo Pharma has secured usfda approval for generic versions of diabetes treatments Dapagliflozin and Dapagliflozin/Metformin ER. These approvals, for multiple strengths, will bolster the company's US generics portfolio. Manufactured at its subsidiary's facility, the products are set for immediate launch, targeting significant market shares and potentially offering Aurobindo 180 days of shared exclusivity.

A usfda team's visit to Odisha's shrimp hatcheries and farms for quality checks has boosted optimism among producers for increased production and exports. The team expressed satisfaction with the standards, and a favorable report is expected to strengthen export prospects and the aquaculture sector, despite past tariff pressures.

The US Food and Drug Administration (usfda) closed the inspection at homegrown pharma major Zydus Lifesciences Ltd’s Moraiya facility near Ahmedabad. The pharma giant received an establishment inspection report (EIR) from the usfda, the company said on Monday.

Sun Pharma announced on Tuesday that the US drugs regulator — US Food and Drug Administration (usfda) has issued a ‘Form 483’ after inspecting its Halol facility in Gujarat.

Giving a strong boost to its bid to continue exporting pharmaceutical products to the US, Indoco Remedies Limited has received the go-ahead from the US food and drug administration (usfda) to manufacture and supply sterile and solid dosages for the US market

Lupin, Glenmark, Natco Pharma recall various drugs in the US due to manufacturing issues. usfda initiates recalls for health risks. India maintains a significant global market share in generic medicines.

Zydus Pharmaceuticals' US arm Nesher Pharmaceuticals Saturday said it has received final approval from the usfda to market Omega-3-Acid Ethyl Esters Capsules USP (USRLD - Lovaza Capsules).

Data integrity issues that include inappropriate manufacturing practices and overlooking results while testing medicines have taken centre stage this year, with several domestic pharma firms being hauled up by the US Food and Drug Administration (usfda) over the issue.

Jubilant Pharma’s credit profile remains unaffected by the US Food and Drug Administration's (usfda) recent regulatory action at its Roorkee facility in India, Fitch Ratings has said. “The plant makes generic solid-dosage products and has limited contribution to JPL's revenue and earnings due to the Singapore-based company's greater focus on speciality-pharmaceutical segments,” the agency said.

New Delhi, Nov 16 () The US Food and Drug Administration (usfda) has issued a warning letter to Lupin for violation of current good manufacturing practice norms at two of its manufacturing facilities in Goa and Indore.

New Delhi, Mar 28 () Alkem Laboratories today said the US Food and Drug Administration (usfda) has pointed out 14 observations for objectionable conditions at its manufacturing units at Amaliya in Daman and St Louis in the US following inspections.

Zydus Lifesciences Limited on Friday said that it has received an establishment inspection report (EIR) from the US Food and Drug Administration (usfda), for its Jarod injectables manufacturing facility at Jarod, near Vadodara.

The city-based Serum Institute of India Ltd is likely to enter the exclusive league of usfda (Food and Drug Administration) approved Indian pharma companies which manufacture generic versions of anti-cancer injectable drugs.

Sun Pharma Advanced Research Company Ltd on Tuesday said the usfda has ruled against its appeal related to Taclantis, its under development product for treatment of breast cancer.

The United States Food and Drug Administration (usfda) on Saturday said its quality checks are part of surveillance system and the number of inspections has increased in India in view of rising exports of generic drugs from the country.

The United States Food and Drug Administration (usfda) has warned homegrown pharma major Dr Reddy's Laboratories (DRL) that if the company fails to take corrective actions at three of its manufacturing facilities-Srikakulam, Miryalaguda and Duvvada-it may lead to imposition of an import ban on these units.

A team of 12 officials and experts from the US Food and Drug Administration (usfda) will visit the state from May 17 to 19.

The issuance of Form 483 implies that the usfda found certain procedural lapses and has sought corrective action from the company. The issuance of a warning letter -- which is more serious--implies that the company cannot export drugs manufactured at the facility to the US.

Gurgaon-based pharma major Ranbaxy Laboratories is said to be negotiating a settlement with US Food and Drug Administration (usfda) to clear two of its manufacturing plants from which the US agency had halted sales.

Lupin, which has come under the glare of the usfda, said that the inspection does not affect the supply of products from its Mandideep facility to other parts of the world.