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SOLARA ACTIVE PHARMA SCIENCES LIMITED — Regulatory Filings 2020
Jun 23, 2020
61842_rns_2020-06-23_7beb22bc-76e2-4faf-9806-48508a7c196f.pdf
Regulatory Filings
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Communication Address: Solara Active Pharma Sciences Limited Batra Centre
No. 28. Sardar Patel Road. Post Box 2630 Guindy. Chennai - 600 032. India Tel : +91 44 43446700. 22207500 Fax : +91 44 22350278 E-mail : [email protected] www.solara.co.in
June 23, 2020
The BSE Limited
Phiroze Jeejeebhoy Towers Dalal Street, Mumbai - 400 001 Scrip Code: 541540
The National Stock Exchange of India Limited Exchange Plaza, Bandra-Kurla Complex Sandra (E), Mumbai - 400 051 Scrip Code: SOLARA
Dear Sir/ Madam,
Subject: Regulatory updates related to Solara’s Cuddalore facility
We wish to inform that the United States Food and Drug Administration (USFDA or agency) vide its letter on June 22, 2020, has informed the Company about classifying our manufacturing site at Cuddalore, Tamil Nadu as “Official Action Indicated”(OAI). This outcome is based on the USFDA’s inspection at the site between March 2 to March 7, 2020.
While we are disappointed with this classification, we are strongly committed to collaborating with the USFDA to satisfactorily resolve the issues raised by the agency in the form 483 issued to the Company.
The reclassification of the Cuddalore site will not impact the business continuity for FY21. The Company continues to maintain its FY21 guidance both on the revenues and EBITDA. The Company is committed to providing further updates as and when it is available to us.
Thanking you, Yours Truly, For Solara Active Pharma Sciences Limited S. Murali Krishna Company Secretary
Solara Active Pharma Sciences Limited - CIN : L24230MH2017PLC291636
REGD. OFF: 201, Devavrata, Sector 17, Vashi Navi Mumbai - 400703. India/ Tel: 91-22-2789 2924 / 2789 3199 / Fax: 91-22-2789 2942