Live news , top stories, corporate news, company news, sector news, economy news, results analysis news, ceo interviews, fund manager interview, advisor interview, market news, bazaar talk, hot stocks news, ipo news, commodities news, mutual fund news, insurance news, news wire
17 February, 2019 11:27 IST
USFDA completes inspection of Lupin's Mandideep location
Source: IRIS | 05 Dec, 2018, 03.31PM
Comments  |  Post Comment

Pharma major Lupin announced today the completion of United States Food and Drug Administration (US FDA) inspections carried out at its Mandideep location. Lupin's Mandideep location houses the company's cardiovascular ''Pril'' API facilities, Cephalosporin API facilities and Cephalosporin Solid Oral Dosage Form facility. These inspections were carried out between November 26 and December 4, 2018.

The inspection at Unit-2, the Cardiovascular ''Pril'' API facilities closed with 4 observations.

The inspection at Unit-1, the Cephalosporin facilities closed with 10 observations for the Cephalosporin API facilities and 8 observations for the Cephalosporin Solid Oral Dosage Form facility.

The observations are largely procedural in nature with some gaps identified in the aseptic processing areas of the Cephalosporin API block and the company is confident of addressing them satisfactorily. 

As a company,  Lupin has committed to an enhanced Quality Management System and Compliance Sustainability Plan.  The Lupin Mandideep site is already executing the plan, which also serves to address some of the concerns raised during this inspection.

There are no new DMF and ANDA applications pending for review or approval from Lupin's Mandideep facilities.

Shares of the company declined Rs 28.95, or 3.26%, to trade at Rs 859.10. The total volume of shares traded was 171,672 at the BSE (3.23 p.m., Wednesday).



Lupin Limited   (Q,N,C,F)*

Comments Post comment 
 Post Comment
Name Email
Comment
Security Code type    into this box
Sector
Lupin launches Clobazam oral suspension - 15-Feb-2019 16:37
Zydus gets USFDA nod for Triamterene & Hydrochlorothiazide capsules - 13-Feb-2019 13:10
L&T Construction bags contract for construction of hospitals - 13-Feb-2019 11:56
Strides receives USFDA approval for Triamcinolone Acetonide cream - 13-Feb-2019 11:52
Lupin receives FDA approval for Fluoxetine Tablets - 12-Feb-2019 16:32
Lupin launches Tadalafil Tablets - 12-Feb-2019 16:29
C & C Constructions JV wins order worth Rs 1.24 bn from DFCCIL - 12-Feb-2019 13:44
Tata Motors group global wholesales up 12% in January 2019 - 12-Feb-2019 13:39
Alembic Pharma announces completion of USFDA inspection at Aleor Dermaceuticals - 12-Feb-2019 10:37
L&T Hydrocarbon Engineering bags order from Sonatrach-Algeria - 12-Feb-2019 10:32
Aurobindo Pharma completes acquisition of businesses in 5 European countries - 11-Feb-2019 11:05
more...
Home  |   Shares  |   F&O  |   Mutual Funds  |   Loans  |   Insurance  |   News Centre
Wealth Tracker  |   Newsletters  |   Tax Corner  |   NRI Centre  |   Advertise
© All rights reserved. IRIS Business Services Limited
A Disclaimer