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SOLARA ACTIVE PHARMA SCIENCES LIMITED — Regulatory Filings 2019
Sep 27, 2019
61842_rns_2019-09-27_5cda363d-e109-407f-9dfa-6876ef91a1fa.pdf
Regulatory Filings
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SOLARA Active Pharma Sciences
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
September 27, 2019
The BSE Limited Phiroze Jeejeebhoy Towers Dalal Street, Mumbai - 400 001
The National Stock Exchange of India Limited Exchange Plaza, Bandra-Kurla Complex Bandra (E), Mumbai - 400 051
Scrip Code: 541540
Scrip Code: SOLARA
Dear Sirs,
Sub: Press release on Ranitidine Hydrochloride Drug Substance
Solara has submitted Drug Master File (DMF) in various regulated markets. The Company has received request for information from USFDA and EDQM to provide test data on N-nitrosodimethylamine (NDMA) content in Ranitidine Hydrochloride drug substance.
The Company is in the process of responding to the information request comprehensively by second week of October 2019. Further updates on the product will be provided post completion of the requisite tests.
The Company has temporarily suspended production and distribution of Ranitidine Hydrochloride drug substance.
Ranitidine Hydrochloride is one of the top 10 APis contributing ~5% to the overall revenue of the Company. We do not foresee any significant impact on the growth trajectory of the Company.
This is for your information and records
Thanking you,
Yours faithfully,
For Solara Active Pharma Sciences Limited
l'�'e,-f S. Murali Krishna Company Secretary
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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