Search Result for : Aurobindo Pharma

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, ...

The Dollar Business Bureau Aurobindo Pharma on Monday announced that it has received the go-ahead from the US-based health regulator USFDA to manufacture and market its anti-infective Linezolid injection in the American market.  "The company has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Linezolid injection, 600 mg/300 mL (2 mg/mL)," Aurobindo Pharma said in a statement. The company plans to launch the product during the second quarter of the current financial year. It has the generic version of Pharmacia & Upjohn Company's Zyvox injection in the same strength.   "The approved product has an estimated market size of $87 million for the twelve months ending June 2016 according to IMS," it said. This latest approval is Aurobindo Pharma’s 36th abbreviated new drug ...

The Dollar Business The FIPB (Foreign Investment Promotion Board) has cleared proposals amounting to Rs.13,030 crore that includes the proposals of Axis Bank asking to increase the shareholdings of foreign investors to 74 percent. According to the finance ministry sources,  in its meeting on Friday, the government panel has cleared five proposals out of 14. Axis Bank, the third largest private sector bank in India, got the nod from the government to increase the limit of foreign direct investment (FDI) from 62 percent to 74 percent. The proposal involves an inflow of foreign investment of around Rs 12,900 crore. Currently, the private banks in India have a limit on accepting foreign investment to 74 percent, and the limit for Foreign Institutional Investors (FII) is ...

 The Dollar Business Bureau Aurobindo Pharma Ltd. on Friday announced that it has earned the US Food & Drug Administration (USFDA) nod to produce and market Dexmedetomidine Hydrochloride injection. This drug is used as a sedation of non-intubated patients who are required to follow surgical or various other types of procedures. The injection will be launched in April-July this year. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Precedex Injection, 200 mcg/2 mL, of Hospira, Inc.,” Aurobindo Pharma said in a statement. “The product has an estimated market size of $59.1 million for the twelve months ending January 2016,” the company said. The company’s Unit IV manufacturing facility has so far secured 27 ANDA ...

 The Dollar Business Bureau Hyderabad-based Aurobindo Pharma Ltd. on Tuesday announced it has received the US Food & Drug Administration (USFDA) approval to manufacture and market Ibandronate Sodium Tablets 150 mg – used in the treatment and prevention of osteoporosis in postmenopausal women. This new product is expected to be launched sometime in April – June 2016-17. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Boniva Tablets of Hoffman-La Roche Inc,” Aurobindo Pharma Ltd. said in a statement. Ibandronate Sodium Tablets 150 mg has an estimated market size of 55 million for a period of twelve months ending January 2016. With the approval of this new product, Aurobindo Pharma’s Unit VII formulation facility in ...

The Dollar Business Bureau    Hyderabad-based Aurobindo Pharma Ltd. on Saturday announced that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Tranexamic Acid injection, (100 mg/mL) 1000 mg/10 mL single-dose vial. Tranexamic Acid injection is used in the treatment of short-term control of bleeding in hemophiliacs, including dental extraction procedures, and this product is expected to be launched by the end of March 2016. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Cyklokapron injection, 100 mg/mL, of Pharmacia and Upjohn Company,” Aurobindo Pharma said in a statement. The approved product has an estimated market size of $50 million annually and is in the WHO’s list of ...

Aurobindo Pharma, with its competitively priced generic drugs, eyes on the growing Saudi market of high-quality medicines The Dollar Business Bureau On Monday,Aurabindo Pharmaannounced that it has got final approval from the USFDA to manufacture and market Norethindrone Acetate tablets, which has an estimated market size of $24 million per annum. Indian drug maker Aurobindo Pharma will set up a manufacturing unit at King Abdullah Economic Citys (KAEC) Industrial Valley in Saudi Arabia to produce oral tablets and capsules. The companys investment arm has already leased a site in phase one of the industrial valley to build its manufacturing facility. The deal is part of the joint effort by KAEC and the National Industrial Clusters Development Programme, with pharmaceuticals being one of six major industries ...

Dexamethasone Sodium Phosphate injection had an estimated market size of $31 million for the twelve months till September 2015 The Dollar Business Bureau So far, Aurobindo Pharma Ltd. has acquired 17 ANDAs (including one tentative approval) approvals for manufacturing general injectable products   Indian drug major Aurobindo Pharma Ltd. on Wednesday announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL (1 mL, 5 mL and 30 mL vials). "The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Dexamethasone Sodium Phosphate injection USP, 4 mg/mL, of Luitpold Pharmaceuticals Inc.," Aurobindo Pharma Ltd. said in a statement. Dexamethasone Sodium Phosphate injection is used for ...