Page 5 - Alembic Pharmaceuticals

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 ...

Alembic Pharma gains on JV with Orbicular

The stock was up 7% at Rs 611 on the BSE as compared to 0.54% rise in S&P BSE Sensex at 11:27 am.