The tentative approval by the United States Food and Drug Administration (USFDA) has been granted under the President's emergency plan for AIDS relief (PEPFAR), Lupin said in a regulatory filing.
The company initiated Class II nationwide (US) recall of the affected lot on December 12 last year.
The company said it has introduced Sacubitril and Valsartan under two brand names, Valentas and Arnipin, in strengths of 200 mg, 100 mg, and 50 mg, in India.
The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing.
These are the generic equivalent of Effient tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc.
Lupin Pharmaceutical got the United States' drug regulator's nod to market fesoterodine fumarate extended-release tablets
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The product will help by improving lung function, providing better symptom control and reducing exacerbations.
With the US labour market showing no signs of cooling off yet, and a tight labour market a major challenge for the US Fed, the worry that rates may stay high for a while have got markets jittery. Also on the show - Santo’s thoughts on Railtel Corp, Ingeroll Rand, Rail Vikas Nigam & Lupin.
Lupin has been overall moving in a rising channel and recently taken support near to Rs 720 zone which is also its 50 DEMA. It formed a bullish candle along with a decisive hold Rs 760 zone.
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The company's product -- Diclofenac Sodium Topical Solution 2 per cent -- is the generic version of Horizon Pharma Therapeutics Pennsaid, Lupin said in a statement.
Spiro, who had most recently served as president of Specialty Generics business at Mallinckrodt Pharmaceuticals and the president of US Injectables at Hikma, will be responsible for the overall strategy, implementation and growth of Lupin's US generics business
As per IQVIA data, Rufinamide tablets had estimated annual sales of USD 138 million in the US.
European markets were muted on Friday to close out an upbeat week, as the US Federal Reserve’s latest meeting minutes added to expectations that monetary policy tightening may slow down. As Nifty scales to record highs, we tell you how to make the most of your investments. On the technical front, we spotlight Paytm, Lupin.
Sharekhan is bullish on Lupin has recommended buy rating on the stock with a target price of Rs 855 in its research report dated November 14, 2022.
European markets extend gains on Fed slowdown hopes. Stoxx600 gained 0.5%, all other key bourses in the Eurozone also ended firmly in the green. In our what’s trending segment, we do a deep dive into internet companies PB Fintech and Paytm. On the technical front, we train the spotlight on Lupin, PNB and Fino Payments Bank.
ICICI Direct recommended reduce rating on Lupin with a target price of Rs 680 in its research report dated November 11, 2022.
Sharekhan is bullish on Lupin has recommended buy rating on the stock with a target price of Rs 855 in its research report dated November 14, 2022.
Motilal Oswal recommended Neutral rating on Lupin with a target price of Rs 680 in its research report dated November 10, 2022.
Prabhudas Lilladher recommended hold rating on Lupin with a target price of Rs 650 in its research report dated November 11, 2022.
Revenue of the company was up 1.3% at Rs 4,145.5 crore versus Rs 4,091.3 crore, YoY.
The company has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Drospirenone Tablets in 4 mg strength, the Mumbai-based drug maker said in a statement.