Page 4 - Alembic Pharmaceuticals

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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.

USFDA issues four observations to Alembic Pharma's Panelav plant

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 Pharma receive USFDA approval to market drug for skin treatment

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

Alembic Pharma gets USFDA nod for cancer treatment drug in US market

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 Pharma gets USFDA approval to market Pirfenidone tablets

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.

USFDA rush after 2-year lull: 20-30% new products may be open to inspection

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

Alembic gets final USFDA nod for medication to treat bronchoconstriction

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 arm receives final USFDA approval for generic fever blisters drug

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.

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.