Page 3 - Alembic Pharmaceuticals

Alembic gets USFDA nod for generic injection to treat hereditary angioedema

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Icatibant injection indicated for the treatment of acute attacks of hereditary angioedema in adults. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing. This is the first peptide product approval from the USFDA received by the company, Alembic Pharma said. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals USA, Inc, it added. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Hereditary angioedema is a disorder characterised by recurrent episodes of severe swelling (angioedema)

Alembic Pharma Q3 results: Profit up 48% as raw material cost declines

This increase in PAT was attributed to tax deduction, decline in the cost of materials consumed, and improvement in Ebitda

Alembic Pharma Q3 results: Profit at Rs 180 cr on strong domestic, US sales

Alembic Pharmaceuticals' revenue from operations rose 8% in the December-quarter, led by a 9% rise in its India and U.S. businesses each

Alembic Pharmaceuticals clinches eight USFDA approvals in Q3 FY24

The same day, Alembic Pharma's share price rose to 3.55 per cent, ending the day's trade at Rs 792 apiece on the BSE

Alembic Pharmaceuticals' revenue surges 8.17%, PAT up 3.21% in Q2FY24

The API business reported a 10 percent growth in revenues, reaching Rs 322 crores in the quarter

Manufacturing disrupted at Sikkim plant due to flash floods: Alembic Pharma

Alembic Pharmaceuticals on Wednesday said flash floods in the Teesta River has led to disruption in operations at its Sikkim-based manufacturing plant. "We would like to inform that due to flash floods in river Teesta because of cloud burst, water entered our manufacturing facility at Namthang, South Sikkim, and hence manufacturing operations stand disrupted with effect from October 4," the drug firm said in a regulatory filing. There is no loss or harm caused to any personnel, it said, adding that the assessment of loss will take a while. All assets of the company are adequately insured and necessary intimations have been given to insurance companies, it added. A sudden cloud burst over Lhonak Lake in North Sikkim has resulted in flash floods in the Teesta in Lachen valley, which was compounded by the release of water from a dam. Shares of Alembic Pharma were trading 1.31 per cent down at Rs 780.50 apiece on the BSE.

Alembic Pharma Q1 consolidated profit rose to $14.6 mn on strong sales

Indian drugmaker Alembic Pharmaceuticals posted first-quarter profit on Friday, boosted by strong sales in its domestic and US markets

Pharma companies seek price ceiling exemption for low-cost medicines

The industry and the government are on the same page on trade margin rationalisation, however, the industry wants it to be implemented in a phased manner

Alembic Pharma gets USFDA nod to market generic antidepressant drug

Alembic Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic antidepressant medication in the American market. The company has received an approval from the US Food & Drug Administration to market Brexpiprazole tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the drug firm said in a statement. The company's product is therapeutically equivalent to Otsuka Pharmaceutical Co's reference listed drug product Rexulti tablets, it added. Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for the treatment of schizophrenia. According to IQVIA data, Brexpiprazole tablets in strenghts of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 1.6 billion for 12 months ended December 2022. The US market is the world's largest for pharmaceutical products. In 2021-22 fiscal, India's total pharma exports to global ...

Alembic Pharma slips 5%; board approves Rs 1,150 cr as impairment charges

This one time impairment impact notwithstanding, we believe this move bodes well for future return ratios and profitability. We expect more impairments in due course, ICICI Securities said in a note.

Alembic Pharma gets USFDA approval to market generic cancer drug

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market a generic breast cancer drug. The company has received approval from the US Food & Drug Administration (USFDA) to market Docetaxel Injection in multiple dose vials, the drug maker said in a statement. The company's approved product is therapeutically equivalent to Hospira Inc's drug. Docetaxel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck. According to IQVIA data, Docetaxel injection has an estimated market size of USD 11 million in the US market. Shares of the company were trading 0.72 per cent down at Rs 506.40 apiece on the BSE.

Trading strategies for Bata India and Alembic Pharma by Mehul Kothari

BATA INDIA has been correcting from 1,950 without any meaningful bounce

Alembic Pharma Q3 net dips 29% to Rs 122 cr, revenue rises to Rs 1,509 cr

Alembic Pharmaceuticals on Thursday said its consolidated net profit declined by 29 per cent to Rs 122 crore in the December quarter. The Vadodara-based drug maker had reported a net profit of Rs 172 crore in the October-December quarter of last fiscal. Revenue from operations rose to Rs 1,509 crore in the period under review from Rs 1,272 crore in the year-ago period, Alembic Pharmaceuticals said in a statement. "The company witnessed top-line growth across all the verticals. In particular, the API business outperformed with a 65 per cent growth during the quarter," Alembic Pharmaceuticals Managing Director Pranav Amin stated.

Alembic Pharmaceuticals gets USFDA nod to market generic cancer drug

The company's product is therapeutically equivalent to AstraZeneca UK's Calquence Capsules (100 mg)

Stocks to Watch: NTPC, LIC Housing, Alembic Pharma, SIS, Gail, Puravankara

Stocks to Watch: In the F&O space, Punjab National Bank (PNB) is the only stock in ban period on Tuesday.

Alembic Pharma gets USFDA nod for generic drug to treat breast cancer

Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer. The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added. Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data.

Lupin set to gain market share in US flu season; shares up 6% in 2 sessions

The stock has underperformed peers and the benchmark over the past year

Tax sops for craft paper, textile, pharma units in Madhya Pradesh

The Madhya Pradesh government is leaving no stone unturned to facilitate investment assistance to various sectors

Alembic Pharma gets USFDA nod for generic cancer treatment medication

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market Cyclophosphamide capsules, used in the treatment of different kinds of cancers, in the American market. The company has received approval from the US Food and Drug Administration (USFDA) to market its product which is a generic version of Hikma Pharmaceuticals USA Inc product, Alembic Pharmaceuticals said in a statement. Cyclophosphamide capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients. According to IQVIA, cyclophosphamide capsules, 25 mg and 50 mg, have an estimated market size of USD 8 million in the US for twelve months ending Sep 2022. Shares of the drug firm were trading 1.32 per cent down at Rs 630.35 apiece on the BSE.

Alembic Pharma Q2 net profit dips 19% to Rs 133 crore on higher expenses

Alembic Pharmaceuticals on Friday said its consolidated net profit declined by 19 per cent to Rs 133 crore for the second quarter ended September 2022 on account of higher expenses. The drug maker had reported a net profit of Rs 164 crore in the July-September period of last fiscal. Revenue from operations rose to Rs 1,475 crore in the September quarter as against Rs 1,292 crore in the year-ago period, Alembic Pharmaceuticals said in a regulatory filing. Expenses during the period under review stood at Rs 509 crore as compared to Rs 428 crore earlier. "It was a satisfactory quarter led by growth in all the verticals of the company, in particular the API business outperformed with a 23 per cent growth during the quarter," Alembic Pharmaceuticals Managing Director Pranav Amin said in a regulatory filing. Shares of the company on Friday ended 3.68 per cent up at Rs 638.75 apiece on the BSE.