Alembic Pharma

Higher capex and depreciation post commercialisation, increased operating costs as well as interest costs are expected to hit the company's FY22 earnings

Further, the board has delegated its authority to a fund-raising committee which shall be authorised to take decisions with respect to the issue

Drug firm Alembic Pharmaceuticals reported more than two-fold jump in net profit to Rs 301.46 crore for the quarter ended on June 30, 2020, mainly on account of robust sales in international markets

The product is therapeutically equivalent to Synjardy tablets of Boehringer Ingelheim Pharmaceuticals, Inc

The tablet is the generic of Janssen Pharmaceuticals Inc's reference listed drug product Xarelto

Domestic growth rebounds to double digits; will keep overall momentum on even keel

Strides Pharma Science, Alkem Laboratories, Ajanta Pharma, Lupin, Ipca Laboratories, Jubilant Life Sciences and FDC were up in the range of 5 per cent to 10 per cent on the BSE

Alembic Pharmaceuticals on Thursday said it has received final nod from the US health regulator for fenofibrate tablets, which reduces cholesterol and triglycerides in blood. "Alembic Pharmaceuticals Limited (Alembic)...has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg. "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc (AbbVie)," the drug firm said in a BSE filing. Fenofibrate tablets have an estimated market size of USD 100 million for twelve months ending September 2019, according to IQVIA. "Fenofibrate tablets are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia," it said. Alembic .

Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity. "The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said. Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million

Stock calls and Outlook on Nifty by Sameet Chavan, Chief Analyst- Technical & Derivatives, Angel Broking Ltd

Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA

The company said it now has a total of 86 ANDA approvals from the USFDA

Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Carbidopa and Levodopa extended-release tablets, used for treatment of Parkinson's disease. The approved products are therapeutically equivalent to the reference listed drug Sinemet CR tablets of Merck Sharp & Dohme Corp. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application Carbidopa and Levodopa extended-release tablets in the strengths of 2.5 mg/100 mg and 50mg/200 mg, Alembic said in a BSE filing. Quoting IQVIA sales data, the company said the two products had an estimated market size of USD 24 million for 12 months ended December 2018. The company said it now has a total of 94 abbreviated new drug application (ANDA) approvals from the USFDA. Shares of Alembic Pharmaceuticals were trading at Rs 511.05 apiece, down 0.08 per cent, on the BSE.

Alembic hold 44% in partnership with China's SPH SINE Pharma, whose stake will be 51%. The JV will set up plant there

Division bench says court will hear Bayer if the export by the two companies is done for purposes other than research

The approved product is therapeutically equivalent to the reference listed drug Optivar Ophthalmic Solution of Mylan Specialty L P.

Consolidated revenue from operations stood at Rs 1,018.15 crore in the reported quarter as against Rs 840.02 crore in December quarter 2017

Shares of Alembic Pharmaceuticals were trading 0.42 per cent lower at Rs 615 apiece on BSE

The company currently has a total of 82 ANDA approvals from USFDA

Drug firm Alembic Pharmaceuticals Tuesday said its subsidiary has received the US health regulator's nod for Glycopyrrolate tablets, used in the treatment of peptic ulcer. The company's wholly owned subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Glycopyrrolate tablets USP in the strengths of 1 mg and 2mg, Alembic Pharmaceuticals said in a BSE filing. The product is a therapeutic equivalent of Casper Pharma's Robinul and Robinul Forte tablets, it added. Quoting IQVIA data, Alembic Pharmaceuticals said Glycopyrrolate tablets USP, 1 mg and 2 mg have an estimated market size of USD 15 million for 12 months ending December 2017. The company now has a total of 81 ANDA approvals from the USFDA. The stock was trading at Rs 617.60 apiece, up 0.32 per cent, on the BSE.