Page 7 - Alembic Pharmaceuticals

Alembic Pharma gets final nod from USFDA for infection treatment drug

Azithromycin tablet is a macrolide antibacterial drug indicated for mild to moderate infections

Alembic sees India sales recovering from Q1FY21, expects 10-12% growth

This financial year should see 15-20 product launches in the US

Alembic gets USFDA nod for Tizanidine hydrochloride capsules for spasticity

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

Alembic Pharma gets USFDA nod for ointment to treat various skin disease

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

Alembic Pharmaceuticals plans to raise up to Rs 5 bn through issue of NCDs

Alembic Pharmaceuticals board also constituted NCD Committee for issue and allotment of NCDs

Alembic Pharma gets US FDA nod for Xylocaine pain relief ointment

The approved product is therapeutically equivalent to AstraZeneca Pharmaceuticals' Xylocaine ointment, 5 per cent

Alembic Pharma Q2 profit up 64% to Rs 2 bn; revenue at Rs 11.3 bn

International formulations sales grew to Rs 5.87 billion from Rs 2.62 billion in the year-ago period, the company said

Alembic Pharma up 8% as USFDA approves Doxycycline Hyclate capsules

The stock has moved higher by 8% to Rs 530, bouncing back 11% from early morning low of Rs 478 on the BSE.

Alembic Pharma zooms 20% as USFDA gives nod for anti-depression drug

The stock is locked in upper circuit of 20% at Rs 522 after the company received approval from the USFDA for its ANDA Bupropion hydrochloride tablets USP, 75 mg and 100 mg.

Alembic Pharma acquires US-based firm Orit Labs; shares jump nearly 2%

The mid-cap company has equity capital of Rs 37.70 crore. Face value per share is Rs 2

Alembic Pharmaceuticals eyes 50% turnover from US market by 2020

Vadodara-based Alembic Pharmaceuticals, which inaugurated its oncology oral solids facility at Panelav in the Panchmahals district on Friday, 150 km from here, is betting on the segment to drive its US sales in the medium term. It says it expects US sales to contribute to half its revenues by 2020. At present, generic exports account for nearly half its turnover (of Rs 2,986 crore in 2016-17). Pranav Amin, joint managing director, said the contribution of exports (including active pharmaceutical ingredients or bulk drug shipments) to overall turnover would be 60-65 per cent by 2020. "In the next two to three years, the share of international sales in our turnover should be around 60 per cent. The US will have the biggest share, about 50 per cent of our overall turnover, by 2020," he told Business Standard. As a growth strategy, the company has aggressively started investing in the international generics market, with focus on abbreviated new drug applications (ANDAs) and drug master ...

Alembic Pharma gains 6% on USFDA nod for new drug

The company received USFDA tentative approval for its ANDA for Dabigatran Etexilate Capsules, 150 mg

Alembic Pharma to file 100 ANDAs in US in 3 yrs as part of expansion plans

Drug firm Alembic Pharmaceuticals is looking at filing 100 abbreviated new drug applications with the US health regulator over the next three years starting this fiscal as part of its expansion plans. An ANDA contains data that provides for the review and ultimate approval of a generic drug product by the United States Food and Drug Administration (USFDA). "...We hope to file 100 ANDAs in the next three years (starting 2017-18) - a sizable proportion of which would comprise challenging products (Para IV/First To File (FTF) opportunities)," Alembic Pharmaceuticals MD Pranav Amin said. The company is also aiming to launch up to 12 products per year in America during this time. "We target to launch 10-12 products each year in the US market during the same timeframe," Amin said in his statement in the Annual Report of the company for the fiscal year ended March 31, 2017. Stronger regulatory filing pace is a immediate fallout of the company's R&D efforts. ...

Alembic Pharma gains on successful USFDA inspection at Baroda facility

The stock moved higher by 7% to Rs 645 on BSE in intra-day trade.

Alembic receives USFDA approval for Itraconazole capsules

Itraconazole capsules had an estimated market size of $42 million for twelve months ending December 2015

Alembic Pharma receives EIR report from USFDA

The stock of the company was trading at Rs 684.55, up 3.70 per cent, from its previous close on BSE

Alembic Pharma gains as Panelav unit receives EIR from USFDA

The stock moved higher by 6% to Rs 700 on BSE

Alembic Pharma gets tentative nod from USFDA for Febuxostat

Alembic stock was trading 0.57% up at Rs 582.75 in the morning trade on BSE

Alembic Pharma surges on successful USFDA audit of Panelav API facilities

The stock surged 9% to Rs 595 on the BSE in intra-day trade.

Alembic-Orbicular form JV to develop dermatology products for global markets

Vadodara-based Alembic Pharmaceuticals Ltd has entered into a 60:40 joint venture with Hyderabad-based Orbicular Pharmaceutical Technologies Pvt Ltd and MS Mohan, to develop, manufacture and commercialise dermatology products for worldwide markets. Orbicular has capabilities in developing dermatology products with a fully-equipped and staffed research laboratory in Hyderabad and has a pipeline of products under various stages of development. It is privately held pharmaceutical research company that develops and licenses specialty pharmaceutical products in niche dosage domains like complex injectables, dermatology and ophthalmics.A manufacturing facility will be established in Aleor Dermaceuticals (Aleor) to enableworldwide registrations. APL and Orbicular will own 60 per cent and 40 per cent of the equity capital of Aleor when the transaction is completed. The JVA has standard terms including transfer of employees, financing and borrowing, management functioning, restriction on ...