Alembic Pharmaceuticals

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 ...

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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.

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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.

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

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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.

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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 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.

Alembic Pharmaceuticals Ltd on Tuesday said the US health regulator has issued a Form 483 with four procedural observations after inspection of its oncology injectable formulation facility at Panelav in Gujarat. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The USFDA had conducted an inspection at the facility located at Panelav from October 4, 2022, to October 14, 2022, Alembic Pharmaceuticals said in a regulatory filing. "The USFDA issued a Form 483 with 4 procedural observations. None of the observations is related to data integrity, and management believes that they are addressable," it added. The company further said it is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period.

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Alembic Pharmaceuticals on Friday said its subsidiary has received approval from the US health regulator to market medication for treating actinic keratoses

Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancers, in the American market

Alembic Pharmaceuticals said it has received approval from the US health regulator to market Pirfenidone tablets used to treat lung disease in the American market.

The last two years saw limited physical inspections due to travel restrictions during the pandemic

Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Arformoterol Tartrate inhalation solution indicated for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Arformoterol Tartrate inhalation solution is for strength of 15 mcg (base)/2 mL unit-dose vial, the company said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Brovana inhalation solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc, it added. Arformoterol Tartrate inhalation solution is indicated for long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, the company said. This ANDA has ...

Alembic Pharmaceuticals on Wednesday said its wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic Docosanol cream indicated for cold sore/fever blisters on the face or lips. The final approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Docosanol cream, 10 per cent (over the counter), the company said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product Abreva Cream, 10 per cent (OTC) of GlaxoSmithKline Consumer Healthcare, it added. Citing IQVIA data, Alembic said Docosanol cream, 10 per cent (OTC) has an estimated market size of USD 60 million for 12 months ending December 2021. Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA, it added.