Unichem Laboratories : ANDA approval from USFDA for Unichem’s Chlorthalidone Tablets

August 12, 2019
The BSE Limited	The National Stock Exchange of
Phiroze Jeejeebhoy Towers	India Limited
Dalal Street	Exchange Plaza,
Mumbai 400 001, India	Plot no. C/1, G Block
Scrip Code: 506690	Bandra-Kurla Complex
	Sandra (East)
	Mumbai - 400 051, India
	Symbol: UNICHEMLAB

Dear Sir,

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 ANDA approval from USFDA for Unichem's Chlorthalidone Tablets USP, 25 mg and 50 mg.

For Unichem Laboratories Limited

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Pradeep Bhandari

Head - Legal & Company Secretary

Registered Office: Unichem Bhavan, Prabhat Estate, Off S. V. Road, Jogeshwari (West), Mumbai - 400 102, Maharashtra, India.

Tel.: [phone] • Fax.: [phone] • Website: www.unichemlabs.com • CIN: L99999MH1962PLC012451

Mumbai, Monday, August 12, 2019

PRESS RELEASE

Unichem Laboratories Limited is pleased to announce that it has received ANDA approval from USFDA for Unichem's Chlorthalidone Tablets USP, 25 mg and 50 mg to market a generic version of Hygroton® Tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC which are indicated for:

• the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.
• adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
• the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

The Product will be commercialized from Unichem's Ghaziabad plant.

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: [phone] [e-mail]

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.

Registered Office: Unichem Bhavan, Prabhat Estate, Off S. V. Road, Jogeshwari (West), Mumbai - 400 102, Maharashtra, India.

Tel.: [phone] • Fax.: [phone] • Website: www.unichemlabs.com • CIN: L99999MH1962PLC012451