Page 2 - Alembic Pharmaceuticals

Alembic Pharma posts Q4 net of Rs 35 cr as India and US businesses grow

During the quarter, Alembic Pharma's US portfolio strengthened with the acquisition of the balance 40 per cent stake in Aleor Dermaceuticals

Alembic Pharma reports consolidated PAT at Rs 35 cr in March qtr

Alembic Pharmaceuticals on Monday reported a consolidated profit after tax (PAT) of Rs 35 crore for the fourth quarter ended March 2022. The company said the PAT is post charging off non-recurring expense of Rs 188 crore. The drug firm had reported a PAT of Rs 251 crore in the January-March quarter of 2020-21 fiscal, Alembic Pharmaceuticals said in a statement. Revenue from operations rose to Rs 1,416 crore for the fourth quarter of 2021-22, compared to Rs 1,280 crore in the year-ago period. For the year ended March 31, 2022, the company reported a consolidated PAT of Rs 546 crore as against Rs 1,178 crore in 2020-21. Revenue from operations for the last fiscal also declined to Rs 5,306 crore from Rs 5,393 crore earlier. "India branded business continues to deliver strong market beating growth in Q4. India business witnessed market outperforming growth across most of the products and therapy areas," Alembic Pharmaceuticals Managing Director Shaunak Amin noted. The company said i

Alembic gets USFDA nod to market lvabradine used in treating heart failure

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market lvabradine tablets, used to treat heart failure, in the American market. The company has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for lvabradine tablets (5 mg and 7.5 mg), Alembic Pharmaceuticals said in a regulatory filing. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). lvabradine Tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure. lvabradine Tablets are also indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. According to IQVIA, ...

Alembic Pharma fully acquires Aleor Dermaceuticals from JV partner

Picks up remaining 40% stake from JV partner Orbicular Pharmaceutical

Alembic acquires 100% stake in Aleor Dermaceuticals from JV partner

The move is aimed at strengthening its skin-related manufacturing and marketing footprint

Alembic Pharma targets 10-12 product filings from Karkhadi facility

Resolution of the observations made by the USFDA (for which Alembic has already responded to the regulator) is critical for Alembic's US business

Alembic Pharmaceuticals joint venture gets USFDA nod for anti-fungal drug

Alembic Pharmaceuticals Ltd on Tuesday said its joint venture, Aleor Dermaceuticals Ltd (Aleor), has received final approval from the US health regulator for its generic version of Nystatin and Triamcinolone Acetonide ointment used for the treatment of cutaneous candidiasis. Cutaneous candidiasis is an infection of the skin and nails caused by the candida fungus. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment of strength 100,000 units/gram, Alembic Pharmaceuticals said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD) Nystatin and Triamcinolone Acetonide ointment of Taro Pharmaceuticals USA Inc, it added. The company further said Nystatin and Triamcinolone Acetonide ointment is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides ...

Price erosion in US drags Alembic Pharma's Q3 net down 40% to Rs 176 cr

While the firm's US business fell 23% to Rs 393 cr in Q3FY22, its API sales were down 7% to Rs 198 crore

Alembic Pharmaceuticals gets USFDA nod to market generic product

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market generic Dronedarone tablets, which is used to reduce risk of hospitalisation for atrial fibrillation, in the American market. The company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its medication in strength of 400 mg, the drug maker said in a statement. The tentatively approved ANDA is therapeutically equivalent to Sanofi-Aventis' Reference Listed Drug (RLD) product Multaq Tablets, 400 mg. Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation. Cumulatively, the company has so far received 158 ANDA approvals from USFDA.

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