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The drugs include Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets and the company is the exclusive first-to-file for this products
Drug firm Lupin on Friday said it has received approval from the US health regulator to market a generic HIV medication in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for Abacavir, Dolutegravir and Lamivudine tablets, the Mumbai-base drug maker said in a statement. The company's product is a generic equivalent of ViiV Healthcare Company's Triumeq PD tablets for oral suspension, it added. This product would be manufactured at the drug firm's Nagpur facility and will be supplied to low-and middle-income countries, it said. The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. "The tentative approval from the USFDA for our Abacavir, Dolutegravir and
These granules, available in 25 mg, 50 mg, and 75 mg per unit dose packets, are a generic equivalent of Kalydeco Oral Granules
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
Lupin, headquartered in Mumbai, India, is a global pharmaceutical player with products distributed in over 100 markets
IREDA stock is seen attempting a breakout on the daily scale, while SJVN is testing support at the key monthly moving average, which the stock has held since August 2020; shows the technical charts.
The stock of the pharmaceutical company, Lupin is quoting higher for the sixth straight trading day; it has rallied 10 per cent during the period
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The Huminsulin range is vital for managing both type 1 and type 2 diabetes, helping control blood sugar levels in adults and children
Lupin stock has broken out of a triple bottom pattern on the daily chart. It has also crossed above its key moving average suggesting bullish sentiment
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Long build up is seen in the Lupin Futures, where we have seen 2 per cent rise in the open interest with price rising by 1 per cent
Lupin share price gained after the company announced that it has received tentative approval from the United States Food and Drug Administration (US FDA)
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Drug firm Lupin is recalling over six lakh bottles of a medication indicated for high blood pressure in the US due to deviation from current good manufacturing practices (CGMP), according to the US health regulator. As per its latest Enforcement Report, US Food and Drug Administration (USFDA), stated that Dr Reddy's Laboratoties is also recalling a product in the US due to a manufacturing issue. Baltimore-based Lupin Pharmaceuticals Inc, a subsidiary of Mumbai-based Lupin, is recalling 6,16,506 bottles of Ramipril capsules in strengths of 2.5 mg, 5 mg and 10 mg, the US health regulator said. The affected lot is manufactured at Lupin's Goa-based manufacturing facility, it stated. The company is recalling 1,12,770 bottles of 2.5 mg tablets; 1,46,322 bottles of 5 mg tablets and 3,57,414 bottles of 10 mg tablets, it said. The US health regulator noted that the company is undertaking Class II voluntary recall due to "CGMP Deviations: Active pharmaceutical ingredient was sourced from an
Stocks to watch, November 8, 2024: Cochin Shipyard reported a Q2FY25 net profit of Rs 193 crore, which is slightly lower than Rs 200 crore in the same period last year
Consolidated net profit of the company, which makes biosimilars and active pharmaceutical ingredients, rose to Rs 853 crore (about $101 million) for the quarter ended Sept. 30
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Brokerages expect Lupin to report a strong quarter on a year-on-year basis, while a quieter one sequentially