Glenmark Pharmaceuticals

History

Glenmark Pharmaceuticals was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer. He named the company after his two sons. The company initially sold its products in India, Russia, and Africa. The company went public in India in 1999. Saldanha's son Glenn took over as CEO in 2001, having returned to India after working at PricewaterhouseCoopers. In 2008 Glenmark was the fifth-biggest pharmaceutical company in India.

By 2011 the founder of the company was one of the richest men in India, and Glenmark had worldwide sales of $778 million, a 37% increase over the last year's sales; the growth was driven by Glenmark's entry into the US and European generics markets.

In the mid-2010s the generics industry in general began transitioning to the end of an era of giant patent cliffs in the pharmaceutical industry; patented drugs with sales of around $28 billion were set to come off patent in 2018, but in 2019 only about $10 billion in revenue was set to open for competition, and less the next year. Companies in the industry responded with consolidation or trying to generate new, patented drugs.

Under Glenn Saldanha, the company focused on developing new drugs In 2016 it had four such drugs in clinical trials. Its R&D developed a drug to treat asthma and COPD and licensed this to North America and Japan. It also licensed out a new diabetes drug to the German Merck. For the financial year 2016–2017 its sales were around 81 billion INR (ca. $1.25 billion), making it the fourth-biggest Indian pharmaceutical company.

In May 2019, Yasir Rawjee became CEO of Glenmark Life Sciences.

Quality control issues

In October 2019, following an inspection by the US Food and Drug Administration (FDA) of Glenmark's plant in Himachal Pradesh, the FDA sent Glenmark a warning letter in which it detailed "significant violations of current good manufacturing practice."

In August 2021, Glenmark recalled every product being produced at its plant near Charlotte, North Carolina. A subsequent investigation in 2022 by the FDA documented 17 violations of manufacturing standards and resulted in an FDA warning letter for the plant.

In November 2022, the FDA sent Glenmark a warning letter about its plant in Goa, India, which stated that the plant lacked the procedures necessary to verify that drugs produced by the plant had the strength, quality, and purity claimed by Glenmark.

In September 2024, Glenmark's product Telma-H (telmisartan) was subject to a ‘Not of Standard Quality’ (NSQ) alert by India's Central Drugs Standard Control Organisation (CDSCO). The company asserted that they had not produced the drug.

In July 2025, the FDA sent Glenmark another warning letter, following an inspection of the company's plant in Madhya Pradesh in February 2025 that uncovered problems with cleaning and drug testing at the plant. In the letter, the FDA noted that similar problems had been found at three other Glenmark manufacturing sites that had previously been the subject of warning letters, stating that "These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate."

References

References

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