SOLARA ACTIVE PHARMA SCIENCES LIMITED — Regulatory Filings 2019

Oct 23, 2019

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PRESS RELEASE

FOR IMMEDIATE CIRCULATION

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WWW.SOLARA.CO.IN | BSE:541540 NSE: SOLARA BLOOMBERG: SOLARA: IN | SECTOR: PHARMACEUTICALS

Further Updates on Ranitidine Hydrochloride API

Bangalore, India – October 23, 2019: Solara Active Pharma Sciences Ltd (Solara) (NSE: SOLARA; BSE: 541540) today shared further updates to its earlier release dated September 27, 2019 titled “Press release on Ranitidine Hydrochloride” . The Company, in September 2019, received request for information from USFDA, EDQM & TGA to provide test data on N-nitrosodimethylamine (NDMA) content in Ranitidine Hydrochloride API and voluntarily suspended production and distribution of Ranitidine for all the markets.

The Company would like to share that TGA[1] , on October 22, 2019, published results of 135 samples of Ranitidine medications from 10 Australian companies available in the market. As per the results, out of the 135 batches, only 24 oral solid dosage batches were found to have levels of NDMA within the acceptable limit of 0.3 ppm and all these batches were produced using the API supplied by Solara.

These tests were conducted adopting the recently recommended test methods by USFDA.

About Solara

Solara Active Pharma Sciences Ltd (BSE-541540, NSE-SOLARA) headquartered in Bengaluru, India offers a basket of diversified, high-value Commercial APIs and Contract manufacturing services in over 75 countries. It has a manufacturing base comprising five globally compliant API facilities, with approvals including the USFDA, EU GMP and PMDA in Japan.

Investor / Analyst contact	Statutory and corporate affairs
Abhishek Singhal	Murali Krishna S
Investor Relations Consultant	Raghavan. V
 abhishek.singhal@solara.co.in	 investors@solara.co.in
+91 99877 66968	+91 44 4344 6700

Disclaimer: Certain statements in this document that are not historical facts are forward-looking statements. Such forward-looking statements are subject to certain risks and uncertainties like government actions, local, political or economic developments, technological risks, and many other factors that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements Solara Active Pharma Sciences Ltd will not be in any way responsible for any action taken based on such statements and undertakes no obligation to publicly update these forward-looking statements to reflect subsequent events or circumstances.

1 https://www.tga.gov.au/tga-laboratories-testing-ranitidine-medicines