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Alkem Laboratories Ltd.

BSE: 539523 Sector: Health care
NSE: ALKEM ISIN Code: INE540L01014
BSE 00:00 | 18 Oct 1959.65 44.15
(2.30%)
OPEN

1943.85

HIGH

2029.80

LOW

1939.70

NSE 00:00 | 18 Oct 1958.95 40.10
(2.09%)
OPEN

1920.20

HIGH

2027.90

LOW

1920.10

Announcement under Regulation 30 (LODR)-Press Release / Media Release

July 30, 2019, 6:15 pm | Source: BSE | Downlaod PDFDownload PDF

In furtherance to the intimation captioned US FDA Inspection at Alkems manufacturing facility located at Baddi India dated 17th May 2019 this is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Companys manufacturing facility located at Baddi India which was inspected from 13th May 2019 to 17th May 2019.

In response to the Form 483 issued by the US FDA containing four observations the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.

Kindly take the same on record.