Page 19 - Aurobindo Pharma

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 ...

Aurobindo Pharma dips on USFDA procedural observations on Hyderabad unit

The stock dipped 4.7% to Rs 633 on BSE in late noon deal.

Aurobindo Pharma gets USFDA nod for HIV treatment drug

The stock of Aurobindo Pharma was trading 0.98 per cent higher at Rs 678 on the BSE

USFDA gives final nod for Aurobindo's Meropenem anti-bacterial injection

BS Reporter Hyderabad, 28 MarchAurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Meropenem injection, which is used in the treatment of complicated skin and other bacterial infections. Meropenem injection 500 mg/vial and 1 g/vial will be launched next month. This is a generic version of AstraZeneca Pharmaceuticals' Merrem Injection. It is indicated as single agent therapy for skin infections, complicated intra-abdominal infections such as appendicitis and peritonitis, and bacterial meningitis, the company said in a statement.According to IMS, Meropenem has an estimated market size of $118 million for the twelve months ending January 2017. This is the first abbreviated new drug application (ANDA) approved out of its subsidiary Auronext Pharma's formulation facility in Bhiwadi. This unit is used for manufacturing penem injectable products. With this, the Hyderabad-based company has an overall 314 ANDA approvals ...

US court favours Aurobindo in patent case on cough & cold drug

The court has scheduled a five-day bench trial beginning April 17 to deliver a final judgment

Aurobindo Pharma's Reddy transfers holding to trustee company

FM Arun Jaitley has imposed a 10% tax on dividend income on shares held by trusts

Aurobindo Pharma eyes US plant as Trump's 'border tax' hangs fire

Aurobindo reported a lower-than-expected October-December profit on Friday

Aurobindo acquires four biosimilar products under development

They were acquired from TL Biopharmaceutical AG of Switzerland

Aurobindo Q3 net rises 6% to Rs 578 cr

The total income of the company increased 11% to Rs 3,906 cr

Aurobindo aims for top-5 position in Europe

Firm eyes Euro 1 bn revenue in the continent, seeks to hike market share to 3% from 2% currently

Aurobindo strengthens its presence in Europe

The Portuguese acquisition should rub off positively on the stock

Aurobindo buys Portuguese firm for Rs 963 crore

To become leader in Portugal's generic drugs market

Aurobindo Pharma to buy Portugal-based Generis for Rs 969 cr

Acquisition includes Generis' facility in Amadora which can manufacture 1.2 bn tablets annually

Compass: Concerns overdone on Aurobindo Pharma

FDA observations, lawsuit impact to be negligible while earnings momentum is expected to continue

Aurobindo Pharma Unit 1 gets US FDA observations

The plant is used for manufacturing of active pharmaceutical ingredients

Aurobindo pharma to acquire select products in France from Teva

Both companies intend to ensure continuity of the supply of the products to the market