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SOLARA ACTIVE PHARMA SCIENCES LIMITED — Regulatory Filings 2018
Nov 9, 2018
61842_rns_2018-11-09_0da8946f-f027-4165-85ca-886d7cf38eee.pdf
Regulatory Filings
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CIRCULATION
WWW.SOLARA.CO.IN | BSE:541540 NSE:SOLARA BLOOMBERG:SOLARA:IN | SECTOR:PHARMACEUTICALS
Solara’s Mangalore facility receives Establishment Inspection Re ort from USFDA p
Bengaluru, India – November 09, 2018: Solara Active Pharma Sciences Ltd (Solara) (NSE: SOLARA; BSE Code: 541540), a leading Active Pharmaceutical Ingredient provider today announced the completion of USFDA inspection at its multi-product API facility in Mangalore. As part of GMP compliance audit, the Company has received Establishment Inspection Report (EIR) from USFDA, thereby confirming the closure of the inspection in July 2018.
Solara’s Mangalore facility is one amongst the four USFDA approved facilities in the Company. It houses six clean rooms with best in class infrastructure for the development and manufacture of niche APIs and API Intermediates. In addition to the USFDA, the site is also approved by TGA (Australia), KFDA(Korea) and WHO (Geneva) and has four CEPs for its APIs with more in the pipeline. It has filed 30+ drug master files covering USFDA, Europe, WHO, Australia, Canada with several more APIs in the pipeline for future filings.
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 API facilities in India with approvals including the USFDA, EU GMP, KFDA and PMDA in Japan.
Investor / Analyst contact
Statutory contact
Dikshita Jain Murali Krishna S Christensen Investor Relations Raghavan. V [email protected] [email protected] +91 22 4215 0210 +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.