Edition:
United Kingdom

Alkem Laboratories Ltd (ALKE.NS)

ALKE.NS on National Stock Exchange of India

1,717.70INR
22 Mar 2019
Change (% chg)

Rs-36.65 (-2.09%)
Prev Close
Rs1,754.35
Open
Rs1,763.10
Day's High
Rs1,765.70
Day's Low
Rs1,710.00
Volume
36,224
Avg. Vol
41,991
52-wk High
Rs2,268.00
52-wk Low
Rs1,702.00

Latest Key Developments (Source: Significant Developments)

Alkem Labs Says Product Not Being Made At This Time At St Louis Facilty as it Awaits USFDA approval
Friday, 22 Mar 2019 

March 22 (Reuters) - Alkem Laboratories Ltd ::ALKEM LABORATORIES -SUBMITTED RESPONSE TO THE 8 FORM 483 OBSERVATIONS RECEIVED DURING PRE-APPROVAL INSPECTION FOR PRODUCT AT FACILITY AT ST. LOUIS.ALKEM LABORATORIES - SAID PRODUCT IS NOT BEING MANUFACTURED AT THIS TIME AS IT IS AWAITING APPROVAL FROM US FDA..  Full Article

India's Alkem Laboratories Says U.S FDA Inspection At Manufacturing Facility At Daman
Friday, 18 Jan 2019 

Jan 18 (Reuters) - Alkem Laboratories Ltd ::SAYS US FDA INSPECTION AT ALKEM'S MANUFACTURING FACILITY LOCATED AT DAMAN, INDIA..SAYS AT THE END OF THE INSPECTION NO FORM 483 WAS ISSUED.  Full Article

Alkem Laboratories Gets Shareholders' Nod For Continuance Of Samprada Singh Designated As Chairman Emeritus
Monday, 7 Jan 2019 

Jan 7 (Reuters) - Alkem Laboratories Ltd ::GETS SHAREHOLDERS' NOD FOR CONTINUANCE OF SAMPRADA SINGH DESIGNATED AS CHAIRMAN EMERITUS.  Full Article

India's Alkem Laboratories Says Closure Of U.S FDA Inspection At St.Louis manufacturing Facility
Tuesday, 4 Dec 2018 

Dec 4 (Reuters) - Alkem Laboratories Ltd ::US FDA ISSUED ESTABLISHMENT INSPECTION REPORT FOR CO'S MANUFACTURING FACILITY LOCATED AT ST. LOUIS, USA.IN RESPONSE TO FORM 483 ISSUED BY US FDA WITH 1 OBSERVATION, CO SUBMITTED DETAILED CORRECTIVE AND PREVENTIVE ACTION PLAN.SAYS INSPECTION HAS NOW BEEN CLOSED BY THE US FDA.  Full Article

Alkem Labs Says Co Submitted Corrective Action Plan To Regulator For EIR For Daman Plant
Tuesday, 24 Jul 2018 

July 24 (Reuters) - Alkem Laboratories Ltd ::ALKEM LABORATORIES -US FDA HAS ISSUED AN ESTABLISHMENT INSPECTION REPORT (EIR) FOR COMPANY'S MANUFACTURING FACILITY LOCATED AT AMALIYA, DAMAN.SAYS INSPECTION HAS NOW BEEN CLOSED BY US FDA.SAYS INSPECTION OF UNIT WAS FROM 19TH MARCH TO 27TH MARCH.  Full Article

India's Alkem Labs March-Qtr Consol Profit More Than Halves
Wednesday, 30 May 2018 

May 30 (Reuters) - Alkem Laboratories Ltd ::MARCH QUARTER CONSOL PROFIT 670.8 MILLION RUPEES VERSUS PROFIT 1.37 BILLION RUPEES YEAR AGO.MARCH QUARTER CONSOL REVENUE FROM OPERATIONS 15.13 BLNRUPEES VERSUS 12.51 BILLION RUPEES YEAR AGO.RECOMMENDED DIVIDEND OF 7 RUPEES PER SHARE.  Full Article

Alkem Laboratories Gets Form 483 With 13 Observations After U.S. FDA Inspection At Co's Amaliya Facility​
Wednesday, 28 Mar 2018 

March 28 (Reuters) - Alkem Laboratories Ltd ::GOT A FORM 483 WITH 13 OBSERVATIONS AFTER US FDA INSPECTION AT CO'S MANUFACTURING FACILITY AT AMALIYA, DAMAN​.SAYS ‍ US FDA HAD CONDUCTED INSPECTION AT THE FACILITY FROM MARCH 19-27.SHALL PUT TOGETHER DETAILED RESPONSE WITH ADEQUATE CORRECTIVE AND PREVENTIVE MEASURES TO ADDRESS US FDA OBSERVATIONS​.‍IN RESPONSE TO FORM 483 BY FDA AT CO'S ST LOUIS FACILITY, CO HAS SUBMITTED CORRECTIVE AND PREVENTIVE ACTION PLAN ​.  Full Article

Alkem Laboratories Announces Closure of U.S.FDA Inspection at Baddi Manufacturing Facility
Wednesday, 10 Jan 2018 

Jan 10 (Reuters) - Alkem Laboratories Ltd ::SAYS U.S. FDA ISSUES EIR FOR CO'S MANUFACTURING FACILITY AT BADDI.SAYS ‍INSPECTION OF CO'S MANUFACTURING FACILITY AT BADDI HAS NOW BEEN CLOSED BY US FDA​.IN RESPONSE TO TWO FORM 483 OBSERVATIONS ISSUED BY FDA, CO SUBMITTED DETAILED CORRECTIVE AND PREVENTIVE ACTION PLAN TO REGULATOR.  Full Article

India's Alkem Laboratories Gets Shareholders' Nod For Appointment Of Sandeep Singh As MD
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Alkem Laboratories Ltd ::GETS SHAREHOLDERS' NOD FOR APPOINTMENT OF SANDEEP SINGH AS MD.GETS SHAREHOLDERS' NOD FOR RE-APPOINTMENT OF DHANANJAY KUMAR SINGH AS JOINT MD.  Full Article

India's Alkem Labs Sept-qtr consol profit rises
Friday, 10 Nov 2017 

Nov 10 (Reuters) - Alkem Laboratories Ltd ::Sept quarter consol profit 3.27 billion rupees versus 2.88 billion rupees year ago.Sept quarter consol revenue from operations 18.65 billion rupees versus 16.38 billion rupees year ago.  Full Article

UPDATE 2-FDA approves generic valsartan amid drug shortage

March 12 The U.S. Food and Drug Administration said on Tuesday it had approved a new generic version of blood pressure medicine valsartan, as the agency looks to ease shortages triggered by several manufacturers recalling the drug over possible cancer risk.