Page 5 - Alembic Pharmaceuticals

Alembic Pharma gets tentative USFDA approval for depressive disorder drug

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder. The tentative approval granted by the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the company said in a statement. These are therapeutically equivalent to the reference listed drug product (RLD) Trintellix tablets 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals, USA, Inc, it added. Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021. Alembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome. "It is possible that our ANDA may not be ...

Stocks to Watch: RIL, Wockhardt, IDBI Bk, SJVN, Titan, DMart, FMCG, Pharma

Pharma shares may be in focus as India's apex health research organization ICMR has raised concerns around the safety for use of the oral antiviral drug Molnupiravir

Alembic Pharma gets USFDA nod for generic drug to treat Parkinson's disease

Alembic Pharmaceuticals on Thursday said it has received final approval from the US health regulator for its generic Entacapone tablets indicated for patients with Parkinson's disease. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Entacapone tablets is for strength of 200 mg, the company said in a regulatory filing. It is therapeutically equivalent to the reference listed drug product (RLD) Comtan tablets, 200 mg, of Orion Corporation. Entacapone tablets are indicated as an adjunct to other medications, levodopa and carbidopa, to treat end-of-dose "wearing-off" in patients with Parkinson's disease. Citing IQVIA data, Alembic said Entacapone tablets 200 mg have an estimated market size of USD 10.5 million for 12 months ended September 2021. In the ongoing fiscal so far, the company said it has received 17 approvals (13 final approvals and 4 tentative approvals) and a cumulative total of 156 ANDA approvals (136 final ..

Alembic gets USFDA nod for generic drug to treat bacterial infections

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate delayed-release tablets

Alembic gets USFDA nod for generic hypertension treatment drug

Alembic said it has so far received 15 product approvals this year

Glenmark, Alembic, Cipla: Pharma stocks on a booster dose this December

Select pharma stocks look good on the technical charts and may jump up to 15 per cent in December. On the fundamental side, fears of Omicron variant spreading may also keep them in news and buzzing

Alembic Pharma gets USFDA nod for formoterol fumarate inhalation solution

Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of formoterol fumarate inhalation solution used for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. The approval for the abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution is for 20 mcg/2 ml per unit-dose vial. It is therapeutically equivalent to Mylan Specialty's 'Perforomist Inhalation Solution', 20 mcg/2 ml per unit-dose vial, Alembic Pharmaceuticals said in a regulatory filing. The formoterol fumarate inhalation solution indicated for long term, twice daily -- morning and evening -- administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, it added. "This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt .

Alembic Pharma dips 5% on disappointing September quarter results

Alembic Pharma said that the USFDA recently inspected the company's injectable facility (F-3) site and issued Form 483 with 10 observations

Alembic Pharma's Q2 net halves to Rs 169 cr as US biz takes 40% dip

Revenue from operations too fell by 11 per cent to Rs 1,292.32 crore in Q2 of FY22

Nifty Pharma index slips 5%, records sharpest intra-day fall in 7 months

Alembic Pharma and Dr Reddy's Labs plunged 12% and 11%, respectively in intra-day trade post their June quarter results

Alembic Pharma dips 8% on disappointing June quarter results

Ebitda (earnings before interest, taxes, depreciation, and amortization) margins declined 1258 basis points (bps) YoY to 17.8 per cent, due to higher other expenditure

Alembic Pharma posts 45% dip in Q1 net at Rs 165 cr amid price erosion

Firm's consolidated revenues from operations also fell marginally to Rs 1,326 cr in Q1FY22, from Rs 1,341 crore a year ago

Alembic Pharmaceuticals gets USFDA nod for bipolar depression drug

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 Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market size of USD 3.7 billion for the twelve months ending December 2020. Lurasidone Hydrochloride tablets are indicated for treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Alembic Pharma said it has settled the cas

Alembic Pharma falls 6% post March quarter results

Alembic Pharma Q4FY21 operational performance was marginally below estimates, largely due to lower traction in US and Domestic Formulation (DF) sales

Alembic Pharma Q4 net up 12% to Rs 251 cr on strong API, global businesses

Net sales rise 6% to Rs 1,280 cr; API business expands by as much as 38%

Alembic Pharma's injectables plant launch may face some delay

Company saw Form 483 with observations issued by US FDA for injectables plant in February

Autos, RIL set-off losses in banks; Sensex dips 20 pts, Nifty holds 15,100

The broader markets, however, bucked the trend and ended higher today. The S&P BSE MidCap and SmallCap indices added 0.7 per cent and 0.4 per cent, respectively at close

Alembic's affiliate Rhizen bags US regulator nod for oral cancer drug

Company says a critical cancer inhibiting component in the formulation is the first new chemical entity discovered by Indian scientists to secure US FDA nod

Alembic Pharma gets five observations from USFDA for Gujarat facility

Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat. "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021. This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company's management of objectionable conditions. Alembic Pharma said none of the observations were related to data integrity and were procedural in nature. "The company is preparing the response to the observations, which will be

Alembic Pharma extends decline on mixed December quarter results

Motilal Oswal Securities said Alembic Pharma missed Q3FY21 earnings estimate, weighed by lower-than-expected sales in the US