July 10, 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 Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg.

Request you to take the same on records.

Thanking you,

For UNICHEM LABORATORIES LIMITED

Digitally signed by

PRADEEP PRADEEPBHANDARI BHANDARI Date: 2021.07.10

11:53:27 +05'30'

PRADEEP BHANDARI

Head- Legal & Company Secretary

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

Mumbai, Saturday, July 10, 2021

PRESS RELEASE

Unichem Laboratories Limited is pleased to announce that it has received Tentative

Approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United

States Food and Drug Administration (USFDA) for a generic version of Januvia®

(sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharpe and Dohme Corp

(Merck).

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Product will be commercialized from

Unichem's Goa 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: pradeep.bhandari@unichemlabs.com

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.

Attachments

  • Original document
  • Permalink

Disclaimer

Unichem Laboratories Ltd. published this content on 10 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 July 2021 09:01:06 UTC.