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SOLARA ACTIVE PHARMA SCIENCES LIMITED — Regulatory Filings 2020
Feb 22, 2020
61842_rns_2020-02-22_7afe3ba2-4ed7-448f-8970-7da615ba688e.pdf
Regulatory Filings
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SOLARA Active Pharma Sciences
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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
February 22, 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 Bandra (E), Mumbai -400 051
Scrip Code: SOLARA
Dear Sir / Madam,
Sub: Announcement under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulation, 2015
We are enclosing herewith a press release issued by the Company titled:
"Solara Puducherry and Mangalore facilities complete USFDA Inspection with zero 483s"
Thanking you,
Yours faithfully, For Solara Active Pharma Sciences Limited ,�� S. Murali Krishna Company Secretary
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Encl:- as above
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
PRESS RELEASE FOR IMMEDIATE CIRCULATION
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WWW.SOLARA.CO.IN | BSE:541540 NSE:SOLARA BLOOMBERG:SOLARA:IN | SECTOR:PHARMACEUTICALS
USFDA conclude inspections at Solara’s Puducherry and Mangalore facility with zero 483 observations
Chennai, India – Feb 22,2020: Solara Active Pharma Science Limited (Solara), a leading Active Pharmaceutical Ingredient provider is pleased to announce that the US Food and Drug Administration (USFDA) has completed two successful inspections of Solara’s state of the art manufacturing facilities at Puducherry and Mangalore. The inspection established that the two sites are in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from USFDA. The agency with their designated auditors inspected the two facilities from 17[th] to 21[st] February 2020.
The Puducherry API manufacturing facility is our centre of excellence for the manufacturing of Ibuprofen and its derivative APIs. The facility was established in the year 1986 and is one of the largest Ibuprofen manufacturing sites in the world. This site is inspected by various Regulatory Authorities including USFDA, MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.
Solara’s multiproduct manufacturing site at Mangalore was established in 1997 and has best in class infrastructure and capabilities to produce niche high-value APIs and API intermediates. In addition to the USFDA, the site also maintains its regulatory status with other leading global agencies such as MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.
Commenting on the audit outcomes, Jitesh Devendra,MD said “We are very happy with the successful Zero 483 outcome of our two sites within the same week. This continues to demonstrate our relentless focus on world-class quality and compliance, which remains a key pillar of our growth strategy. We remain agile to the increasing requirements on quality and compliance, and I am confident that we will sustain our quality culture and anchor it further.”
These inspection outcomes are Solara’s fourth consecutive US FDA audit with “Zero 483s”. In Dec’18,Jan’19 and Jul’19, the USFDA concluded the inspections at our facilities at Solara Research Centre(SRC), Chennai and API manufacturing sites at Ambernath and Cuddalore with zero 483s.
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 |
|---|---|
| Abhishek Singhal | Murali Krishna S |
| Investor Relations Consultant | Raghavan. V |
| [email protected] | [email protected] |
| +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.