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Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg

Mumbai, India, and Mahwah, New Jersey; March 14, 2023 – Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, the generic version of Cleocin®¹ Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc. Glenmark’s Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA^TM sales data for the 12-month period ending January 2023, the Cleocin® Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg market² achieved annual sales of approximately $33.6 million*.

Glenmark’s current portfolio consists of 181 products authorized for distribution in the U.S. marketplace and 47 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation-driven, global pharmaceutical company with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 worldclass manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2021; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2021. The company has been Great Place To Work® Certified™ in India, in 2023. Glenmark has impacted over 2.6 million lives over the last decade through its CSR interventions. For more information, visit www.glenmarkpharma.com. Follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma).

For more information, please contact
Udaykumar Murthy | +91 9960377617 | corpcomm@glenmarkpharma.com

References
¹All brand names and trademarks are the property of their respective owners.
²Market includes brand and all available therapeutic equivalents
*IQVIA^TM National Sales Perspectives: Retail ∓ Non-Retail, January 2023

Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg

Mumbai, India, and Mahwah, New Jersey; March 14, 2023 – Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, the generic version of Cleocin®¹ Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc. Glenmark’s Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA^TM sales data for the 12-month period ending January 2023, the Cleocin® Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg market² achieved annual sales of approximately $33.6 million*.

Glenmark’s current portfolio consists of 181 products authorized for distribution in the U.S. marketplace and 47 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

---End---

About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation-driven, global pharmaceutical company with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 worldclass manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2021; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2021. The company has been Great Place To Work® Certified™ in India, in 2023. Glenmark has impacted over 2.6 million lives over the last decade through its CSR interventions. For more information, visit www.glenmarkpharma.com. Follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma).

For more information, please contact
Udaykumar Murthy | +91 9960377617 | corpcomm@glenmarkpharma.com

References
¹All brand names and trademarks are the property of their respective owners.
²Market includes brand and all available therapeutic equivalents
*IQVIA^TM National Sales Perspectives: Retail ∓ Non-Retail, January 2023