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USFDA
Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility
In a warning letter issued to company's Managing Director Dilip Shanghvi on June 18, the US health regulator stated it inspected the plant in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023.
03 July 2024, 14:11 IST
Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility
03 July 2024, 14:11 IST
US lawmakers question FDA's drug inspection programme in India and China
In a letter to FDA Commissioner Robert Califf, the lawmakers on Monday wrote that the difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA’s foreign drug inspection programme.
25 June 2024, 03:29 IST
US lawmakers question FDA's drug inspection programme in India and China
25 June 2024, 03:29 IST
Lupin, Eugia recall products from US market: US Food and Drug Administration
As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupin is recalling a medication used to treat bacterial infections.
23 June 2024, 06:29 IST
Lupin, Eugia recall products from US market: US Food and Drug Administration
23 June 2024, 06:29 IST
Glenmark gets USFDA nod for generic ophthalmic solution
The final approval by the US Food & Drug Administration (USFDA) is for brimonidine tartrate and timolol maleate ophthalmic solution of strength 0.2%/0.5%.
17 May 2024, 08:57 IST
Glenmark gets USFDA nod for generic ophthalmic solution
17 May 2024, 08:57 IST
UK tightens scrutiny of all Indian spice imports amid contamination allegations
Britain's food watchdog has applied extra control measures on all spice imports from India, it said on Wednesday, becoming the first to ramp up scrutiny of all Indian spices after contamination allegations against two brands sparked concerns among global food regulators.
16 May 2024, 09:05 IST
UK tightens scrutiny of all Indian spice imports amid contamination allegations
16 May 2024, 09:05 IST
Granules gets USFDA nod for generic gout medication
The company's product is therapeutically equivalent to Hikma International Pharmaceuticals LLC's Mitigare Capsules (0.6 mg), it added.
30 April 2024, 07:39 IST
Granules gets USFDA nod for generic gout medication
30 April 2024, 07:39 IST
Zydus unit gets 10 observations from USFDA after inspection
The US Food and Drug Administration (USFDA) inspected the facility at Jarod near Vadodara from April 15 to April 23, the drug maker said in a regulatory filing.
24 April 2024, 08:00 IST
Zydus unit gets 10 observations from USFDA after inspection
24 April 2024, 08:00 IST
Sun Pharma, Lupin recall drugs in US market over manufacturing issue
Mumbai-based Sun Pharmaceutical Industries is recalling 96,192 bottles of Liothyronine Sodium Tablets in the US that are used to treat an underactive thyroid, according to the latest enforcement report issued by the American health regulator.
17 December 2023, 05:23 IST
Sun Pharma, Lupin recall drugs in US market over manufacturing issue
17 December 2023, 05:23 IST
USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit
The USFDA conducted a pre-approval Inspection at the company's oral manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to 11, 2023, Torrent Pharma said in a regulatory filing.
12 December 2023, 07:50 IST
USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit
12 December 2023, 07:50 IST
Indian goods worth $3.7 bn entering Oman to get boost by free trade agreement: GTRI
India and Oman are negotiating a comprehensive economic partnership agreement (CEPA), under which the two countries could significantly reduce or eliminate customs duties on the maximum number of goods agreed between them.
12 December 2023, 07:30 IST
Indian goods worth $3.7 bn entering Oman to get boost by free trade agreement: GTRI
12 December 2023, 07:30 IST
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