Page 12 - Aurobindo Pharma

US inspectors cite serious quality issues at Aurobindo Pharma's Unit 4

BS ReporterHyderabad, 4 March: The US Food and Drug Administration(USFDA) has issued Form 483 with 9 observations to Aurobindo Pharma Limited's unit 4 in Hyderabad, citing serious deficiencies in maintaining the manufacturing quality standards. The FDA representatives had inspected the facility between February 12-20, 2018.Located in Pashamailaram industrial estate on the city outskirts, Unit-4 is a dedicated manufacturing facility for generic sterile injectables ( lyophilized and powder injections, prefilled syringes), opthalmics and low volume parenterals.According to the Form 483, a copy of which was reviewed by this reporter, the inspection team has noticed poor maintenance of equipment and premises among other quality issues at the site.The FDA representative also noted that despite alerting the management regarding certain black stains on a filling machine, no action was taken to remove the dirt, which could potentially impact the quality of the drug product."Equipment and ...

Aurobindo Pharma wrests second position among drug firms from Lupin

While Lupin recorded a 10.6 per cent decline in its sales for the period, the largest, Sun Pharma, recorded a 17.4 per cent fall

Aurobindo Pharma Q3 net profit up 2.8% at Rs 5.95 billion

BS ReporterHyderabad, 7 February: Aurobindo Pharma Limited has reported a 2.8 percent increase in consolidated net profit at Rs 5.95 billion for the quarter ended December 2017 as compared to Rs 5.79 billion in the corresponding quarter previous year.The Hyderabad-based generic drug major's revenues grew 11 percent at Rs 43. 36 billion during the quarter under review from Rs 39.06 billion in the year ago period on the back of a rise in formulation sales across the geographies. Particularly, the company's formulation sales in Europe rose 37 percent at Rs 11.72 billion while the same in the US market grew by 9.4 percent to touch Rs 19.1 billion from Rs 17.45 in the corresponding previous quarter.Formulation sales registered an overall growth of 12.2 percent during the quarter under review despite a 30.1 percent fall in anti retro viral(ARV) sales at Rs 2.39 billion during the perriod.Commenting on the company's performance, Aurobindo managing director N Govindarajan said,"All our key ...

Aurobindo Pharma looks for inorganic growth prospects in East Europe

Earlier this year, the company announced acquisition of Portugal's Generis Farmaceutica SA from Magnum Capital Partners for a consideration of Euro 135 mn

Aurobindo Pharma gets USFDA nod for heartburn drug

Aurobindo Pharma said the product will be launched immediately

Aurobindo's new anti-HIV drug may better its anti-retroviral business

BS ReporterHyderabad, 3 October: The dwindling anti-retroviral(ARV) contribution to the overall revenues of Aurobindo Pharma is likely to see improvement in the second half of the current financial year as the company expects to launch its new Dolutegravir(DTG) triple combination drug in the sub-Saharan Africa in the third quarter.In August the company had received tentative approval from the US Food and Drug Administration(USFDA) under the US President's Emergency Plan For AIDS Relief (PEPFAR) for its new drug application for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets. The company is expected to realise the full revenue potential of the product once it gets the final USFDA approval to be able to launch in the US market. Aurobindo considers DTG as the growth driver in the next 3-4 years in ARV segment. According to the company, the triple drug combination product is expected to have a $ 500 million market in 2018. Aurobindo is the first company to sign license .

Aurobindo to widen portfolio in US, enter new European markets in 3-4 years

Besides, it also plans to increase collaboration across the global customer base

Aurobindo bets on Eastern Europe with larger product base, acquisition

BS ReporterHyderabad, 11 August: Aurobindo Pharma Limited is looking at Eastern Europe as a priority market for inorganic growth as it seeks to further expand its European operations, which came as a strong insurance in the face of headwinds from the US market in the form of steep price erosion."We always actively pursue M&A opportunities for the purpose of market penetration and for new product platforms. When it comes to geographical preference Eastern Europe is more attractive in terms of priority," N Govinda Rajan said in response to a question during the analysts call yesterday.The company's acquisition-led strategy has paid off in Europe, which now accounts for 25 percent of Aurobindo's revenues and growing in double digits even at a time US sales stayed flat despite launching more number of new products.The look out for acquisition opportunities in the Eastern Europe comes close on the heals of the completion of Euro 135 million acquisition of Generis Pharmaceutica by its .

Aurobindo Pharma ups the ante in oncology space

Manufacturing of these drugs would commence from 2018-19

Aurobindo Pharma gets USFDA approval to market kidney ailment drug

Hyderabad, 19 July: Aurobindo Pharma Limited announced today that it has received final approval from the US Food and Drug Administration(USFDA) to manufacture Sevelamer Carbonate tablets 800 mg. Used to lower high blood phosphorus levels in patients who are on dialysis, Sevelamer Carbonate tablets are a therapeutic equivalent generic version of Genzyme's Renvela tablets.The product is being launched immediately.The launch is a significant event for the company as the approved product has an estimated market size off $ 1.9 billion for the twelve months ending may 2017, according to IMS, besides being the 'first generics' of Sevelamer Carbonate approved by the US drug regulator. According to the US FDA website the approval for the Aurobindo's product was given on June 13,2019.This is the 124th ANDA(Abbreviated New Drug Application), to be approved out of Unit VII formulation facility in Hyderabad, according to Aurobindo. "Sevelamer Carbonate tablets is indicated for the control of ...

Aurobindo Pharma surges 8% on USFDA nod for Sevelamer Carbonate tablets

In past one month, the stock has outperformed the market by surging 21% against 1.64% gain in Sensex

Aurobindo Pharma makes a decent start to FY18

In a sector weighed down by bad news for some time, Aurobindo Pharma has done relatively better. In the past month and a half, the stock has outperformed its larger pharma peers on positive news flow. And, there could be more gains.The company made a good start to 2017-18, having got approvals for key generic launches in the US. This holds significance, with the pricing pressure on generics in the US, the world's largest health care market. The company has also seen the completion of a series of successful inspections at many of its facilities here in recent months by the FDA, the American drugs regulator, without any significant adverse comment. The most recent was the inspection of Unit VII; analysts say it got no rap. Unit VII is in a Special Economic Zone and an oral solids manufacturing facility; it is a crucial facility, having received 88 product approvals, 20 tentative ones and 58 filings under review, by the company's presentation. With no major regulatory concerns till now, .

Aurobindo Pharma gains on USFDA nod for Sevelamer Carbonate oral suspension

The stock rallied 6% to Rs 639 on BSE.

Aurobindo Pharma looks to sell cancer drugs in the US by year end

Hyderabad, 11 Jun: Hyderabad-based Aurobindo Pharma Limited is hoping to receive 3-4 product approvals in Oncology space from the US Food and Drug Administration(US FDA) before March, 2018. The company's optimistic prediction about a possible good start in this high-margin product business comes just ahead of a maiden audit slated to be conducted for its Oncology formulations manufacturing facility by the US drug regulator. An R&D facility and a manufacturing plant, both dedicated for the development and production of Oncology and hormonal drugs, was set up in Hyderabad by Aurobindo-controlled Eugine Pharma Specialties Limited, a joint venture with Sequoia-backed Celon Laboratories.Aurobindo holds around 68 percent stake in Eugine Pharma.The product approvals are expected to follow once the facility clears the US FDA inspection, which is scheduled to be conducted in July-August period."This year, we will be filing 15-17 products(Oncology including hormonal) and we can get some 4-5

Street picks Aurobindo Pharma ahead of larger peers on injectibles business

Aurobindo Pharma is among the few companies which are confident about growth in the US market. The company believes that new launches and higher volume will drive growth in US, despite pricing pressure witnessed in the US base business. Management confidence in a sector jittery about US prospects helped the stock rebound from May 25 lows and gain 10.5 per cent since then. The company's March quarter performance like its peers was impacted by price erosion in the US market. The US formulation sales which contributes about 45 per cent to overall revenues is expected to grow just 1.4 per cent y-o-y due to pricing pressure in oral solids which is expected to continue in FY18. However pending launches, company's range of injectable and other complex portfolio is expected to drive revenue and net profit growth. Since April 2015, while the company has received 110 final ANDA approvals, more than 25 are yet to be launched and these together with 115 pending ANDAs should provide strong growth .

Aurobindo Pharma gets USFDA nod to make attention deficit disorder drug

BS ReporterHyderabad, 31 MayAurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture Atomoxetine capsules that are used for the treatment of attention-deficit hyperactivity disorder (ADHD). "Atomoxetine capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg will be launched immediately," the company said. "The product is AB rated, that meets necessary bioequivalence standards, generic equivalent of Eli Lilly and its Strattera capsules."ADHD is a neurobiological disorder that affects normal behaviour and impairs the ability to concentrate. This is widely thought to be a childhood disorder, while adults are also likely to have it. The generic Atomoxetine is manufactured by other companies such as Sun Pharma, Intas and Torrent having brand names Attentrol, Axepta and Tomoxetin. The type of drug comprises of both tablets and capsules. Atomoxetine has an estimated market size of $1.1 billion for the twelve months ...

Aurobindo Pharma gains over 10% on positive growth outlook

The stock had hit a high and low of Rs 568.25 and Rs 506 so far in today's trade.

Aurobindo Pharma Q4 net dips 4% to Rs 532 crore

Total income was lower by 2.6% for the Q4 at Rs 3,682 crore

US regulator's inspections at Aurobindo spook investors

No major negative observations by watchdog, but Street edgy as more inspections lie ahead

Aurobindo's Unit-3 gets Form 483 with six observations

BS Reporter Hyderabad, 19 AprilAurobindo Pharma Limited's formulations manufacturing facility at Bachupally in Hyderabad has received Form 483 with six observations.The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017."The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines," Aurobindo informed the stock exchanges on Wednesday.The USFDA issues Form 483 to a pharma company at the end of inspection if it finds any violation of the Food Drug and Cosmetic Act. The company should respond to the form 483 with a corrective action plan and then implement that expeditiously.Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil. The Bachupally unit is an exclusive multi-product oral dosage form facility spread over 40,469 sq m for non-cephalosporins and ...