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Unichem Laboratories Ltd. — Regulatory Filings 2021
Jun 30, 2021
61109_rns_2021-06-30_2390a453-99dc-4012-a565-a4ad35a436f9.pdf
Regulatory Filings
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June 30, 2021
Department of Corporate Services Mr. Hari K. Bombay Stock Exchange, Asst. Vice President - Operations Phiroze Jeejeebhoy Towers, National Stock Exchange of India Ltd. Dalal Street, Exchange Plaza, Bandra Kurla Complex, Mumbai – 400 001. Bandra (East), Mumbai – 400 051.
Ref: BSE Scrip Code – 506690: NSE Symbol – UNICHEMLAB
Dear Sir,
Sub: Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, please find enclosed herewith the press release pertaining to receipt of Tentative Approval for ANDA from United States Food and Drug Administration (USFDA) for Aripiprazole Tablets, USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg.
Thanking you,
For Unichem Laboratories Limited
PRADEEP Digitally signed by PRADEEP BHANDARI BHANDARI Date: 2021.06.30 22:20:44 +05'30' Pradeep Bhandari Head- Legal & Company Secretary
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Registered Office: Unichem Bhavan, Prabhat Estate, Off S. V. Road Jogeshwari (West), Mumbai – 400 102, Maharashtra, India.
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Mumbai, Wednesday, June 30, 2021
PRESS RELEASE
Unichem Laboratories Limited is pleased to announce that it has received Tentative Approval for ANDA of Aripiprazole Tablets, USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg from the United States Food and Drug Administration (USFDA) for a generic version of ABILIFY® (Aripiprazole Tablets) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg of Otsuka Pharmaceutical Co Ltd.
Aripiprazole Tablets are indicated for Schizophrenia, Irritability Associated with Autistic Disorder and treatment of Tourette’s disorder. Product will be commercialized from Unichem’s Ghaziabad Plant on receipt of full approval.
About Unichem Laboratories Limited
Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. In India, The Company has strong skills in product development, process chemistry and manufacturing complex API as well as dosage forms. More information about the Company can be found at www.unichemlabs.com
For more information please contact:
Mr. Pradeep Bhandari Ph: +91-22-66888 404 E-mail: [email protected]
Disclaimer:
This press release includes forward-looking statements. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ serially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.
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Registered Office: Unichem Bhavan, Prabhat Estate, Off S. V. Road Jogeshwari (West), Mumbai – 400 102, Maharashtra, India.