Pharma
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Lupin Pharma gets tentative approval for Hepatitis B drug.

Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg. The approval allows Lupin to market a generic equivalent of Kalydeco Tablets, 150 mg of Vertex Pharmaceuticals Incorporated. As per the company, the product will be manufactured at Lupin’s Nagpur facility in India. According to IQVIA MAT March 2022, the Ivacaftor Tablets had estimated annual sales of $109 million in the US. Last…
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Dr. Reddy’s Laboratories & Zydus Pharma recalls drugs from U.S.

Leading drug makers Dr Reddy's Laboratories and Zydus Pharma are recalling bottles of a product each, in the US market, for different reasons, according to the latest report of the US health regulator. Dr Reddy's Laboratories, Inc, the US arm of Dr Reddy's Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg, the latest enforcement report by the US Food and Drug Administration (USFDA) said. The tablets are manufactured by Dr Reddy's Laboratories Ltd at its Srikakulam facility, it added. The product is used…
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Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for testosterone topical solution

Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing. Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing. Testosterone Topical Solution actuation is indicated for replacement therapy in males for conditions…
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Black Fungus: 11 Pharma Companies To Produce Amphotericin-B Dru

India's drug regulator has authorized five new companies to manufacture the life-saving injection used to treat Mucormycosis in an attempt to accelerate the production of the antifungal Amphotericin B. According to the ministry, a growing number of patients suffering from COVID complications in the form of Mucormycosis, also known as black fungus, have been identified in recent days in several states and union territories. These companies have been granted licenses to produce Amphotericin-B, a medication used to treat black fungus, and that they will begin manufacturing 1,11,000…
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Alembic Pharmaceuticals announces financial aid up to 50 lakhs for their employees who passed away in Covid.

Vadodara (Gujarat) : When it comes to Employee welfare with Alembic Pharmaceuticals Ltd it is not just the employer but also the employees who have started a Benevolent Fund and are contributing generously for their departed team members who passed in this second wave of Covid. The Management of the 114-year-old Alembic Pharmaceuticals Ltd has announced Financial Aid of between 15 lakhs to 50 lakhs to their deceased employees, which is over and above all other benefits applicable. Talking to the media, Mr. Pranav Amin, Managing Director…
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Alembic Pharmaceuticals recieves USFDA approval for bipolar depression.

Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lurasidone Hydrochloride tablets in the strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, Alembic Pharmaceuticals said in a regulatory filing.Quoting IQVIA data, Alembic Pharma said Lurasidone Hydrochloride…
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Jubilant Pharma wins over Bracco’s Legal appeals in the United States Court of Appeals

Jubilant Pharma Limited ("Jubilant"), a subsidiary of Jubilant Pharmova Limited, announced that it has received a favorable and unanimous judgment from the United States Court of Appeals summarily affirming Jubilant's earlier favorable rulings from the US Patent Office ("PTAB") and the US International Trade Commission ("ITC"). These two rulings by the Appellate Court deny the appeals filed by Bracco Diagnostics, Inc ("Bracco"). Jubilant successfully challenged Bracco's patent infringement claims in an Inter Parties Review (IPR) proceeding before the U.S. Patent Office as well as in a separate…
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Alembic Pharmaceuticals recieves USFDA approval for Opthalmic Solution.

Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, used to treat certain types of glaucoma and other causes of high pressure inside the eye. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Cosopt Ophthalmic Solution, 2 per cent and 0.5 per cent, of Akorn Operating Company LLC. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application…
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Alembic Pharmaceuticals Net Revenue increases 17% to Rs 5393 crores

Net Profit up 42% to Rs 1178 crores for the yearAlembic Pharmaceuticals Limited reported its consolidated financial results for the period ending 31st March 2021. Financial Highlights for the QuarterNet Sales for the quarter up 6% to Rs 1280 crores.Net Profit for the quarter up 12% to Rs 251 crores from Rs 225 crores. Financial Highlights for the YearNet sales for FY21 up 17% to Rs 5393 crores against Rs 4606 crores.Net profit for FY21 up 42% to Rs 1178 crores from Rs 829 crores. Mr. Pranav…
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PharmEasy to vaccinate 3 crore people in coming months

Amid the rising COVID-19 cases in the second wave, we wanted to contribute our bit in breaking the chain by setting up vaccination camps and centres to facilitate this," said Dharmil Sheth, Co-founder, PharmEasy E-pharmacies plan COVID-19 vaccination; PharmEasy to vaccinate 3 crore people in coming months As policies help private COVID-19 vaccine market evolve in India, e-pharmacies are trying to tap the opportunity too. PharmEasy, one of India's leading digital healthcare platforms, plans to vaccinate over 3 crore people via camps and vaccine centres through its…
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