Search Result for : Aurobindo Pharma Ltd

Aurobindo Pharma to expand its US portfolio; eyeing new markets in Europe

The Dollar Business Bureau A leading Indian pharmaceuticals company Aurobindo Pharma has said that it would widen its product portfolio in the American market while planning to enter new markets in the Europe, a part of the company’s growth strategy in the coming 3-4 years. In the US market, Aurobindo Pharma plans to widen its portfolio through faster growth in OTC, injectable and higher complexity products, the company said in a presentation to investors. However, in European market, the company plans to enhance its presence in new geographies like Czech Republic and Poland, in addition to strengthening its position in the existing markets of Germany, France, Spain, Netherlands and the UK. Aurobindo Pharma is the 6th largest generic company by volume in the US, ...

Aurobindo Pharma plans to launch 200 products in Europe

The Dollar Business Bureau Drug manufacturing company Aurobindo Pharma Ltd is planning to launch around 200 products in the European market in the coming four years in order to enhance the product portfolio of the company. “The next lever of growth will come from new products which are being developed. Currently, we have almost 200 products under development for Europe alone and that will be launched over next three to four years,” Sanjeev Dani, COO & Head Formulations, Aurobindo Pharma told analysts. That will be the growth driver in the Europe, he added. In the first quarter of the fiscal 2016-17, the formulations sales of the company in Europe stood at Rs.831.2 crore witnessing a growth of 12.1 percent year-on-year. In the segment of formulations, the EU market ...

Aurobindo Pharma manufactures anesthetic injections in US

The Dollar Business Bureau India-based pharmaceutical manufacturing company, Aurobindo pharma has got approval from the US food and drug administration (USFDA) to produce and market its anaesthetic Bupivacaine Hydrochloride injection in the American market.  The company would manufacture Bupivacaine Hydrochloride Injection USP-0.25% (2.5 mg/mL) and 0.5% (5 mg/mL) 50 mL multiple dose vials. This injection could possibly be launched in the second quarter of FY2016-17. Aurobindo pharma recently mentioned that the sanctioned ANDA is a generic version of Hospira Inc's Marcaine injection. The product’s market size is around $5.6 million for 12 months ended March 2016. “Bupivacaine Hydrochloride injection is used in the production of local or regional anaesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and for obstetrical procedures, the pharma ...

Aurobindo receives approval for Fenofibrate tablets

The Dollar Business Bureau Aurobindo Pharma, a Hyderabad-based firm has announced that they have finally received the approval from US Food & Drug Administration (USFDA) for marketing and manufacturing of Fenofibrate Tablets. The approved Abbreviated New Drug Application(ANDA) is a bio and therapeutic equivalent to the Reference Listed Drug(RLD) Tricor tablets manufactured by AbbVie Inc. The launch of this product is expected in the first quarter of the current fiscal. Aurobindo Pharma in a BSE filing said that the company has received final approval for the marketing and manufacturing of 48mg and 145 mg Fenofibrate tablets. Fenofibrate tablet is used to treat high triglyceride and cholesterol level in the blood. According to IMS health, the estimated market size of the approved drug is $412 million for ...

USFDA okays Aurobindo Pharma's Pantoprazole Injections

The Dollar Business Bureau The USFDA (United States Food and Drug Authority), a regulator, has approved Aurobindo Pharma's Pantoprazole sodium, in 40 mg per single-dose injection vials. The Abbreviated New Drug Application (ANDA), is classified under the Protonix IV category, a similar product approved for Wyeth Pharmaceuticals. The generic drug is sold in multiple combinations under various brands in the form of capsules, injectable and oral suspension. Though considered a lucrative product, the estimated market size, according to IMS, the largest vendor of US' physician-prescription data, is $93.5 million for the twelve months ending February 2016. The drug, among 26 others that have received a confirmed ANDA approval would be manufactured at Hyderabad. Aurobindo has a total of 249 ANDA approvals, and ...

Aurobindo Pharma receives USFDA nod for anti-allergic drugs

The Dollar Business Bureau According to IMS, the approved product has an estimated market size of $235 million for the twelve months ending October 2015   Aurobindo Pharma Ltd. on Tuesday announced that it has received US Food & Drug Administration (USFDA) approval to manufacture and market Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% - a solution used for the treatment of allergic conjunctivitis. “This product is ready for launch. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Patanol Ophthalmic Solution/Drops, 0.1%, of Alcon Laboratories,” Aurobindo Pharma Ltd. said in a statement. According to IMS, the approved product has an estimated market size of $235 million for the twelve months ending October 2015. This is the ...

Indian drug maker gets USFDA nod to market pain relievers

The Dollar Business Bureau Indian drug major Aurobindo Pharma, on Friday, got an approval from the United States Food and Drug Administration (USFDA) to manufacture and market drugs used in the long-term treatment of moderate-to-severe pain in adults. “The company has received final approval from the USFDA to manufacture and market Tramadol Hydrochloride Extended-release Tablets USP, 100 mg, 200 mg and 300 mg (ANDA 204421). This product will be launched by Q4 FY 2015-16,” said an official release. The approved product, having an estimated market size of $56 million for the twelve months ending August (according to IMS), is the 50th Abbreviated New Drug Application (ANDA-US generic drug approval for an existing licensed medication) to be approved at ‘formulation facility for ...

Pharmexcil welcomes foreign investments in pharma sector

Jayarama Emani | The Dollar Business The Pharmaceutical Export Promotion Council of India (Pharmexcil), welcomed the move by The Cabinet Committee on Economic Affairs (CCEA), chaired by the Prime Minister Shri Narendra Modi, to approve two significant foreign investments (FIs) in the pharmaceutical sector - Aurobindo Pharma Ltd; and Glenmark Pharmaceutical Ltd. Speaking to The Dollar Business, Dr P V Appaji, Director General, Pharmexcil said, “The recent move by the Government augurs well for the domestic pharmaceutical companies as they can now augment funds from foreign investors to focus on the export market. Moreover, with the new development, the confidence of the Indian pharma manufacturers will be on a high as these investments show the continued confidence of international ...