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SOLARA ACTIVE PHARMA SCIENCES LIMITED Regulatory Filings 2020

Jan 9, 2020

61842_rns_2020-01-09_bf404489-a095-4ac2-9394-becc6eb324b9.pdf

Regulatory Filings

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SOLARA Active Pharma Sciences

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Communication Address: Sciara 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

January 09, 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: Update on Nizatidine Capsules

We understand from Mylan NVs press release[1 ] dated January 08, 2020, that Mylan N.V.'s U.S. based Mylan Pharmaceuticals(Mylan) has initiated a voluntary recall of three lots of Nizatidine Capsules, USP (150mg and 300mg strengths) due to detected trace amounts of impurity N­ nitrosodimethylamine (NOMA) contained in the Nizatidine APL Mylan also indicated that the recall is voluntary, and the Company has not received any reports of adverse events related to these batches to date.

We are in the process of collecting corresponding lots of API from Mylan to carry out our internal investigation.

We would further inform you that our last supplies of Nizatidine API to Mylan were made in September 2017 and our overall sales of this API to the US market are less than 0.1 % of our total Company revenues.

We do not foresee any significant impact on the growth trajectory of the Company, and any further improvements I updates in this regard will be intimated to Stock Exchanges.

Thanking you, Yours faithfully,

For Solara Active Pharma Sciences Limited

J�� S. Murali Krishna Company Secretary

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.[1 ] http://newsroom.mylan.com/2020-01-08-Mylan-lnitiates-Voluntary-Nationwide-Recali-of-Three-Lots-of-Nizatidine­ Capsules-USP-Due-to-the-Detection-of-T race-Amounts-of-ND MA-N-Nitrosodimethyla mi ne-1 mpurity-Foun d-i n-the­ Active-Ph a rmaceutlca I-Ingredient-Manufactured-by-Sola ra-Active,P harm

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