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Aurobindo Pharma Ltd (ARBN.NS)

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Latest Key Developments (Source: Significant Developments)

Aurobindo Pharma Gets Warning Letter From USFDA For Facility In Andhra Pradesh
Friday, 21 Jun 2019 

June 21 (Reuters) - Aurobindo Pharma Ltd ::RECEIVED WARNING LETTER FROM USFDA FOR UNIT XI, API MANUFACTURING FACILITY AT SRIKAKULAM DISTRICT, ANDHRA PRADESH.SAYS ACTION FOLLOWS EARLIER INSPECTION OF SITE BY USFDA AGENCY IN FEBRUARY 2019.EXISTING BUSINESS FROM THIS FACILITY WILL NOT BE IMPACTED.  Full Article

Aurobindo Pharma Says Recall In U.S, An Expansion Of Recall Initiated In Dec
Monday, 1 Apr 2019 

April 1 (Reuters) - Aurobindo Pharma Ltd ::REFERS TO MEDIA REPORT, SAYS CURRENT RECALL IN U.S. IS AN EXPANSION OF RECALL INITIATED IN DECEMBER 2018.  Full Article

FDA Approves A New Generic Valsartan
Tuesday, 12 Mar 2019 

March 12 (Reuters) - FDA::FDA APPROVES A NEW GENERIC VALSARTAN.U.S. FDA - APPROVAL OF NEW GENERIC OF DIOVAN WAS GRANTED TO ALKEM LABORATORIES LIMITED.FDA SAYS PRIORITIZING REVIEW OF ARB APPLICATIONS TO HELP MITIGATE SHORTAGE OF VALSARTAN.  Full Article

FDA Says AurobindoPharma USA Initiates Voluntary Nationwide Consumer Level Recall Expansion Of Valsartan Tablets
Friday, 1 Mar 2019 

March 1 (Reuters) - U.S. Food and Drug Administration::FDA - AUROBINDOPHARMA USA INITIATES VOLUNTARY NATIONWIDE CONSUMER LEVEL RECALL EXPANSION OF 38 LOTS OF AMLODIPINE VALSARTAN TABLETS & VALSARTAN TABLETS.FDA - AUROBINDOPHARMA USA INITIATING RECALL EXPANSION OF 38 LOTS OF AMLODIPINE VALSARTAN, VALSARTAN TABLETS DUE TO DETECTION OF NDEA IMPURITY.  Full Article

Aurobindo Pharma's Acrotech Biopharma To Buy Portfolio Of Oncology Injectable Products From Spectrum Pharmaceuticals
Thursday, 17 Jan 2019 

Jan 17 (Reuters) - Aurobindo Pharma Ltd ::UNIT ACROTECH BIOPHARMA TO ACQUIRE 7 MARKETED ONCOLOGY INJECTABLE PRODUCTS, PROPERTY, INFRASTRUCTURE FROM SPECTRUM PHARMACEUTICALS.COST OF ACQUISITION IS $160 MILLION UP-FRONT CASH PAYMENT AND UP TO $140 MILLION ON ACHIEVING MILESTONES.PORTFOLIO EXPECTED TO GENERATE REVENUE OF AROUND $100 MILLION FOR FIRST 12 MTHS AFTER DEAL COMPLETION.TRANSACTION WILL BE EPS ACCRETIVE FROM FIRST FULL YEAR OF OWNERSHIP.  Full Article

Spectrum Pharmaceuticals Sells Marketed Portfolio To Acrotech Biopharma
Thursday, 17 Jan 2019 

Jan 17 (Reuters) - Spectrum Pharmaceuticals Inc ::SPECTRUM PHARMACEUTICALS SELLS MARKETED PORTFOLIO TO ACROTECH BIOPHARMA L.L.C. TO FOCUS ON NEW AND INNOVATIVE THERAPIES FOR CANCER PATIENTS.SPECTRUM PHARMACEUTICALS SELLS MARKETED PORTFOLIO TO ACROTECH BIOPHARMA L.L.C. TO FOCUS ON NEW AND INNOVATIVE THERAPIES FOR CANCER PATIENTS.SPECTRUM PHARMACEUTICALS INC - SPECTRUM WILL RECEIVE $160 MILLION IN AN UPFRONT CASH PAYMENT AND UP TO $140 MILLION IN REGULATORY AND SALES-BASED MILESTONES.SPECTRUM PHARMACEUTICALS INC - STAFF SIZE WILL BE REDUCED BY APPROXIMATELY 40 PERCENT WITH MAJORITY OF IMPACTED STAFF TRANSITIONING TO ACROTECH.SPECTRUM PHARMACEUTICALS - WILL RETAIN CORE GROUP OF COMMERCIAL TALENT TO LEAD LAUNCH OF ROLONTIS AND POZIOTINIB.SPECTRUM PHARMACEUTICALS - TO SELL ITS PORTFOLIO OF 7 FDA-APPROVED HEMATOLOGY/ONCOLOGY PRODUCTS TO ACROTECH BIOPHARMA LLC.  Full Article

FDA Alerts Patients, Health Care Professionals To Aurobindo's Recall Of Valsartan Medication Due To NDEA
Wednesday, 2 Jan 2019 

Jan 2 (Reuters) - U.S. Food and Drug Administration::FDA ALERTS PATIENTS AND HEALTH CARE PROFESSIONALS TO AUROBINDO’S RECALL OF VALSARTAN MEDICATION DUE TO NDEA.  Full Article

Aurobindo Pharma Says Unit And Luoxin To Establish JV In China
Tuesday, 11 Dec 2018 

Dec 11 (Reuters) - Aurobindo Pharma Ltd ::UNIT ENTERED DEAL WITH SHANDONG LUOXIN PHARMACEUTICAL GROUP STOCK CO., LTD, CHINA (LUOXIN) TO ESTABLISH JV IN CHINA.SAYS PERCENTAGE OF SHAREHOLDING IN THE JVC WILL BE 30 PERCENT AND 70 PERCENT BETWEEN HELIX AND LUOXIN.JV TO HAVE FACILITIES TO MANUFACTURE NEBULISER INHALER AND OTHER PRODUCTS FOR CHINA, US AND EU MARKETS .ESTIMATED TOTAL PROJECT COST INCLUDING WORKING CAPITAL FOR JV WILL BE $50 MLN.HELIX WILL INVEST $15 MLN, LUOXIN WILL INVEST $35 MLN IN PROPOSED JV IN FORM OF EQUITY IN PHASED MANNER .SAYS COMMENCEMENT OF COMMERCIAL PRODUCTION OF JVC IS EXPECTED DURING 2021.  Full Article

Aurobindo Pharma Gets U.S. FDA Approval To Make Azithromycin Tablets 250 Mg And 500 Mg
Wednesday, 11 Jul 2018 

July 11 (Reuters) - Aurobindo Pharma Ltd ::GETS FINAL APPROVAL FROM USFDA TO MANUFACTURE AZITHROMYCIN TABLETS 250 MG AND 500 MG.DRUG INDICATED FOR TREATMENT OF PATIENTS WITH MILD TO MODERATE INFECTIONS .  Full Article

Aurobindo Pharma Gets USFDA Nod For Ibuprofen OTC Capsules
Monday, 2 Jul 2018 

July 2 (Reuters) - Aurobindo Pharma Ltd ::SAYS RECEIVED USFDA APPROVAL FOR IBUPROFEN OTC CAPSULES.CO'S IBUPROFEN CAPSULES ARE GENERIC EQUIVALENT OF PFIZER’S ADVIL LIQUI-GELS CAPSULES; PRODUCT WILL BE LAUNCHED IN SEP 2018.IBUPROFEN IS USED TO RELIEVE PAIN FROM VARIOUS CONDITIONS SUCH AS HEADACHE, DENTAL PAIN, MUSCULAR ACHES.  Full Article

UPDATE 2-U.S. FDA says Indian drugmaker was shredding, dumping key documents

BENGALURU, July 17 A U.S. Food and Drug Administration (FDA) investigator discovered that India's Strides Pharma Science Ltd, which exports to the U.S. market, was shredding drug production, quality and laboratory documents and dumping others in a scrap yard.