Drugmakers Glenmark Pharma, Cipla plan to step up US manufacturing

The US already contributes a significant share, around a quarter, of Cipla's total revenues

Drugmakers Cipla Limited and Glenmark Pharmaceuticals are open to expanding their manufacturing footprint in the US — a move that could help shield them from potential disruptions linked to evolving tariff regime.

 

The US accounts for around a quarter of total revenue for both Cipla and Glenmark.

 

Cipla is “actively scaling operations in the US”, a key global market for generics, particularly in respiratory and oncology segments, said a person familiar with the development. The company currently operates four manufacturing facilities in New York (3) and Massachusetts (1), focusing on inhalation products, oral therapy sachets, and the production of tablets and capsules. Cipla believes complex generics and peptide-based drugs are two areas where it can achieve long-term strategic growth. 

 

Meanwhile, Glenmark is hopeful that its injectables facility in Monroe, North Carolina, will be back on track in FY26. The company is open to expanding the site further. The facility, which had faced scrutiny from the US Food and Drug Administration (FDA), received a warning letter in 2023.

 

Glenmark’s chairman and managing director, Glenn Saldanha, said the company has “significant benefits flowing through” the Monroe facility. “Our view is, depending on how the whole environment plays out, we are happy to look at further expanding our Monroe site,” he told Business Standard. 

 

The Monroe facility manufactures injectables -- a segment where the US faces drug shortages -- and provides a “differentiated” offering. “It could clearly assist the American consumer, and could fit well into the current narrative of ‘Make in America’,” Saldanha said.

 

With the possibility of increased tariffs on pharmaceutical imports from India and other regions, having a stronger local presence is becoming critical. The person familiar with Cipla’s plans said: “The US already contributes significantly to the revenues, and we expect this share to grow steadily over the next few years.”

 

“Having local manufacturing is not just about tariffs or supply chain resilience -- it’s also about being faster and more agile in responding to market needs,” the source said.

 

Cipla aims to drive this growth through both organic expansion and potential acquisitions. “The company is looking at select partnerships and strategic assets that can enhance its capabilities in injectables, respiratory, and specialty drugs,” the person said.

 

Cipla did not respond to queries on the matter.

 

Speaking recently at a conference, Cipla’s managing director and global CEO, Umang Vohra, highlighted the evolving nature of pharmaceutical manufacturing, noting a shift towards distributed production across multiple geographies.

 

Vohra also warned that strategic decisions should not be driven solely by current tariff structures, which are subject to change. A long-term perspective is crucial, he said, noting that by the time a new facility is operational in the US, existing tariffs may no longer be in effect.

 

Looking ahead, Cipla has a robust pipeline of products targeted at the US market. Key filings include generic versions of respiratory drugs Symbicort and Qvar, with anticipated launches within the next three years. The company is also advancing several peptide and complex generic assets, indicating a focus on differentiated and high-value products.

 

In FY24 alone, Cipla dispensed over 86 million prescriptions in the US, including a significant volume of respiratory medications. As of December 31, 2024, Cipla’s US portfolio and pipeline included 283 abbreviated new drug applications (ANDAs) and new drug applications (NDA), comprising 170 approvals, 34 tentative approvals, and 79 filings currently under review.

 

Automation and AI integration are helping the company accelerate development cycles, particularly in its US-based facilities.

 

In FY24, North America contributed 30 per cent to Cipla’s overall revenue. In Q3FY25, it accounted for 27 per cent, amounting to $226 million.

 

The FDA has ramped up its oversight of large Indian pharmaceutical firms, signalling a subtle shift in US policy -- one that nudges major players to set up shop domestically.