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United States

Aurobindo Pharma Ltd (ARBN.NS)

ARBN.NS on National Stock Exchange of India

722.80INR
20 Feb 2019
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Latest Key Developments (Source: Significant Developments)

Aurobindo Pharma's U.S. Unit Recalled Some Amlodipine Valsartan Tablets, Valsartan Hctz Tablets, Valsartan Tablets On Dec 31
Monday, 28 Jan 2019 03:23am EST 

Jan 28 (Reuters) - Aurobindo Pharma Ltd ::US UNIT INITIATED VOLUNTARY RECALL OF 80 LOTS OF AMLODIPINE VALSARTAN TABLETS , VALSARTAN HCTZ TABLETS, VALSARTAN TABLETS ON DEC 31.SAYS VALUE OF PRODUCTS BEING RECALLED IS NOT MATERIAL .  Full Article

Aurobindo Pharma Gets U.S. FDA Approval For Vecuronium Bromide Injection
Sunday, 23 Dec 2018 11:37pm EST 

Dec 24 (Reuters) - Aurobindo Pharma Ltd ::GETS USFDA APPROVAL FOR VECURONIUM BROMIDE INJECTION.PRODUCT WILL BE LAUNCHED IN Q4FY19.  Full Article

India's Aurobindo Pharma Gets U.S FDA Approval For Potassium Chloride ER Tablets
Friday, 21 Dec 2018 01:55am EST 

Dec 21 (Reuters) - Aurobindo Pharma Ltd ::GETS U.S FDA APPROVAL FOR POTASSIUM CHLORIDE ER TABLETS.SAYS POTASSIUM CHLORIDE TABLETS ARE INDICATED FOR THE TREATMENT OF HYPOKALEMIA.PRODUCT WILL BE LAUNCHED IN JANUARY 2019.  Full Article

Aurobindo Pharma Says Co Not Yet Served With Legal Notice W.R.T. U.S. Suit Over Impurities
Thursday, 6 Dec 2018 03:48am EST 

Dec 6 (Reuters) - Aurobindo Pharma Ltd ::AUROBINDO PHARMA CLARIFIES ON NEWS REPORT ON CO FACING U.S. SUIT OVER IMPURITIES.HAVE NOT YET BEEN SERVED WITH LEGAL NOTICE.  Full Article

European Medicines Agency Says EU Authorities Placing Zheijiang Huahai Under Increased Supervision
Monday, 15 Oct 2018 11:36am EDT 

Oct 15 (Reuters) - European Medicines Agency::EUROPEAN MEDICINES AGENCY - EU AUTHORITIES ARE PLACING THE CHINESE COMPANY ZHEIJIANG HUAHAI UNDER INCREASED SUPERVISION.EMA SAYS INSPECTION FINDINGS INCLUDED DEFICIENCIES IN THE WAY ZHEIJIANG HUAHAI INVESTIGATED IMPURITIES IN ITS VALSARTAN PRODUCTS.EUROPEAN MEDICINES AGENCY SAYS AUROBINDO PHARMA STOPPED FROM SUPPLYING IRBESARTAN TO THE EU.EMA SAYS AUTHORITIES IN EU CURRENTLY CONSIDERING WHETHER TO RECALL MEDICINES CONTAINING AUROBINDO PHARMA’S IRBESARTAN FROM PHARMACIES AS A PRECAUTION.EMA SAYS MARKETING AUTHORISATION HOLDERS FOR EU MEDICINES TO BE REQUIRED TO PERFORM MORE TESTS ON ALL ACTIVE SUBSTANCES SUPPLIED BY ZHEJIANG HUAHAI.EMA- PLACING ZHEIJIANG HUAHAI UNDER INCREASED SUPERVISION AFTER INSPECTIONS SHOWED WEAKNESSES IN QUALITY MANAGEMENT AT ITS CHUANNAN SITE IN LINHAI.  Full Article

Aurobindo Pharma Gets Approval From South African Regulator For Certain Tablets
Tuesday, 18 Sep 2018 12:55am EDT 

Sept 18 (Reuters) - Aurobindo Pharma Ltd ::AUROBINDO PHARMA -APPROVAL FROM SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY FOR DOLUTEGRAVIR, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE TABLETS.  Full Article

Novartis AG Says Faces Impairment Of About Usd70 Million Related To Sale Of Assets To India's Aurobindo, Will Confirm At Q3 Earnings Report On Oct 18
Thursday, 6 Sep 2018 01:29pm EDT 

Novartis Ag ::SAYS FACES IMPAIRMENT OF ABOUT USD70 MILLION RELATED TO SALE OF ASSETS TO INDIA'S AUROBINDO, WILL CONFIRM AT Q3 EARNINGS REPORT ON OCT 18.SAYS FACES IMPAIRMENT OF ABOUT USD70 MILLION RELATED TO SALE OF ASSETS TO INDIA'S AUROBINDO, WILL CONFIRM AT Q3 EARNINGS REPORT ON OCT 18.  Full Article

Aurobindo Pharma Unit To Buy Commercial Ops And 3 Manufacturing Facilities From Sandoz
Wednesday, 5 Sep 2018 10:39pm EDT 

Sept 6 (Reuters) - Aurobindo Pharma Ltd ::UNIT AUROBINDO PHARMA USA ENTERED DEAL TO BUY COMMERCIAL OPERATIONS AND THREE MANUFACTURING FACILITIES IN USA FROM SANDOZ ., USA.DEAL FOR $0.9 BILLION IN CASH ON DEBT FREE AND CASH FREE BASIS INCLUDING POTENTIAL UPSIDE IN NEAR TERM EARN-OUT.DEAL WILL BE AN ALL CASH TRANSACTION WHICH AUROBINDO WILL FINANCE THROUGH A FULLY COMMITTED DEBT FACILITY.  Full Article

India's Aurobindo Pharma March Quarter Consol Profit Slips
Monday, 28 May 2018 09:58am EDT 

May 28 (Reuters) - Aurobindo Pharma Ltd ::MARCH QUARTER CONSOL NET PROFIT 5.29 BILLION RUPEES VERSUS 5.32 BILLION RUPEES LAST YEAR.CONSENSUS FORECAST FOR MARCH QUARTER CONSOL NET PROFIT WAS 5.98 BILLION RUPEES.MARCH QUARTER CONSOL INCOME FROM OPERATIONS 39.89 BILLION RUPEES VERSUS 35.82 BILLION RUPEES LAST YEAR.  Full Article

Aurobindo Pharma Says U.S. FDA Issued Form 483 With 9 Observations for Co's Unit
Monday, 5 Mar 2018 02:36am EST 

March 5 (Reuters) - Aurobindo Pharma Ltd ::AUROBINDO PHARMA LTD CLARIFIES ON NEWS ITEM ON CO'S UNIT 4 GETTING 9 OBSERVATIONS AFTER U.S. FDA INSPECTION.U.S. FDA CONDUCTED INSPECTION AT UNIT IV, HYDERABAD; AT END OF INSPECTION, CO WAS ISSUED FORM 483 WITH 9 OBSERVATIONS.CO WOULD BE REPLYING TO FDA WITHIN 15 WORKING DAYS.  Full Article

Aurobindo Pharma to recall 80 lots of blood pressure medicine valsartan in the U.S.

A U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd will recall 80 lots of medicines containing blood pressure drug valsartan that were found to have a probable cancer-causing impurity, according to the U.S. Food and Drug Administration.