General Announcement::Update on the USFDA inspection of Glenmark Baddi manufacturing facility in Himachal Pradesh

Issuer & Securities

Issuer/ Manager
GLENMARK PHARMACEUTICALS LIMITED
Securities
GLENMARK PH US$200M4.5%210802 - XS1456577334 - 4N4B
GLENMARK PHARM US$170M2%220628 - XS1426780125 - 4G8B
Stapled Security
No

Announcement Details

Announcement Title
General Announcement
Date &Time of Broadcast
05-Oct-2019 14:12:47
Status
New
Announcement Sub Title
Update on the USFDA inspection of Glenmark Baddi manufacturing facility in Himachal Pradesh
Announcement Reference
SG191005OTHRVZK9
Submitted By (Co./ Ind. Name)
Glenmark Pharmaceuticals Ltd.
Designation
Company Secretary & Compliance Officer
Effective Date and Time of the event
07/10/2019 17:00:00
Description (Please provide a detailed description of the event in the box below)
We would like to inform you that in relation to an inspection conducted by the USFDA between April 15, 2019 to April 20, 2019 at the company s Baddi facility in Himachal Pradesh, India, the company had earlier informed that the inspection was classified as an Official Action Indicated vide a letter by the USFDA. With regards to the same inspection, the USFDA has now issued a Warning Letter to the Baddi facility. The company is committed to work along with the USFDA to implement all the necessary corrective actions required to address the concerns raised in the letter and is in the process of preparing a detailed response to the USFDA within 15 working days.
We believe that the existing manufacturing and the sale of products from this facility will not be impacted. The Baddi facility is expected to contribute USD 30mn in total sales for this financial year which is approximately 7% of the total US sales. There are no major pending approvals from this facility in the next 12 months. There will be no financial impact on the organisation on account of this development.

Attachments

CA_SGX_05102019_signed.pdf
Total size =167K