AI assistant
SOLARA ACTIVE PHARMA SCIENCES LIMITED — Regulatory Filings 2021
Jul 2, 2021
61842_rns_2021-07-02_a1082dc4-aa59-46de-906e-266a6d4873e8.pdf
Regulatory Filings
Open in viewerOpens in your device viewer
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
July 2, 2021
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,
Sub: Press release - Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulation, 2015
Please find attached press release issued by the Company titled:
“Restoration of CEP for Ranitidine Hydrochloride Drug Substance granted by EDQM”
Thanking you, Yours Truly, For Solara Active Pharma Sciences Limited
==> picture [145 x 39] intentionally omitted <==
S. Murali Krishna
Company Secretary
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
July 2021
==> picture [165 x 55] intentionally omitted <==
WWW.SOLARA.CO.IN | BSE:541540 NSE: SOLARA BLOOMBERG: SOLARA: IN | SECTOR: PHARMACEUTICALS
Restoration of CEP for Ranitidine Hydrochloride Drug Substance granted by EDQM
-
» Solara is the first company to have its CEP restored among Ranitidine API manufacturers
-
» Validation of Solara’s strong quality systems and robust actions taken in response to emerging regulatory requirements
Bangalore, India – July 2, 2021: Solara is pleased to announce that the CEP for Ranitidine Hydrochloride drug substance (CEP 2001-228) has been restored by EDQM. A revised CEP has been granted as of 01st July 2021. Ranitidine Hydrochloride was an important product for Solara and was manufactured at its Cuddalore site.
Solara had put in place robust manufacturing and quality processes to mitigate the risks of N-Nitroso Dimethylamine (NDMA) formation in the Ranitidine HCL API. Subsequent submission of the pertinent data has fast-tracked the restoration of CEP by EDQM. Solara is currently the only company among Ranitidine API manufacturers to have its CEP restored.
About Solara Active Pharma Sciences Limited:
Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer-oriented API manufacturer. It has a legacy of over three decades and trace its origins to the API expertise of Strides Shasun Ltd. and the technical know-how of human API business from Sequent Scientific Ltd.
It aims at delivering value-based products while maintaining focus on customer needs. It has 140+ scientists working at two R&D centers and 6 API manufacturing facilities armed with global approvals and 2 dedicated R&D facilities. It stands by its vision to respect our partners by maintaining Integrity and operational transparency, which we intend to achieve through developing utmost efficiency across the organization.
Investor / Analyst contact Statutory and corporate affairs Abhishek Singhal Murali Krishna S [email protected] Raghavan. V +91 99877 66968 [email protected] +91 44 4344 6700
Disclaimer: Certain statements in this document that are not historical facts and 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.