Glenmark Pharma USFDA approvals fuel 2025 share gains

What moved Glenmark Pharma shares

Glenmark Pharmaceuticals shares traded firmer on multiple sessions as the company disclosed fresh US Food and Drug Administration (USFDA) approvals for its US arm. One such move was recorded on Friday, March 21, 2025, when the stock rose 2.14 percent to an intraday high of ₹1,509.80 per share. At 10:20 AM that day, Glenmark Pharma was trading 1.56 percent higher at ₹1,501.20.

The rise followed an update that Glenmark Pharmaceuticals Inc., USA, received final USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2 percent. The product is in the over-the-counter (OTC) category and was determined to be bioequivalent to Alcon Laboratories’ Pataday Once Daily Relief Ophthalmic Solution, 0.2 percent (OTC).

The broader market was also positive on that session, with the BSE Sensex up 0.24 percent at 76,531.41 levels, based on the figures cited.

USFDA approval for Olopatadine 0.2% OTC

The Olopatadine approval is part of Glenmark’s steady cadence of filings and approvals in the US market through its US-based subsidiary. The company stated the product falls under the OTC category, which matters because OTC products can address a wider consumer base, depending on distribution and shelf presence.

Glenmark’s disclosure also noted bioequivalence to the reference listed product, Pataday Once Daily Relief Ophthalmic Solution, 0.2 percent. Bioequivalence is a key requirement for generic approvals and often determines whether a product can compete directly with established brands.

While the update did not provide launch timelines or expected sales contribution, the stock reaction indicated that investors were closely tracking regulatory milestones.

Final approval for acetaminophen and ibuprofen tablets

In another development, Glenmark Pharmaceuticals’ share price saw a slight increase in early trade on April 29 after the company received final USFDA approval for acetaminophen and ibuprofen tablets. At the time of writing in the cited update, Glenmark Pharma was trading at ₹1,084.90 on the BSE, up ₹5.55 or 0.51 percent.

The company said the approval is for acetaminophen and ibuprofen tablets, 250 mg/125 mg (OTC). It added that the product is deemed bioequivalent to Advil Dual Action with acetaminophen tablets, 250 mg/125 mg (OTC), of Haleon US Holdings, LLC.

The same update also included stock performance metrics: over the past year, the stock surged 99.47 percent, and since the beginning of the year, it increased 26.79 percent. It also listed a 52-week high of ₹1,095.95 and a low of ₹516.65, with the dates cited as April 25, 2024, and April 26, 2023, respectively.

Another US authorisation and the referenced market size

A separate disclosure cited that shares of Glenmark Pharmaceuticals Ltd. increased 1.24 percent after the company received final authorisation from the US FDA for “premil Tablets” in 10 mg, 20 mg, and 30 mg dosages. The update described these tablets as the generic equivalent of Amgen’s “tez Tablets”.

The same note referenced IQVIA data for the 12 months ending August 2023 and stated that the referenced product generated approximately $1.7 billion in yearly revenue. Normalised to the crore base unit, this works out to about USD 370 crore.

The stock level cited in that update was ₹807.35 at 11:17 AM on the BSE, and the information was published on October 17, 2023.

sANDA approval for Abiraterone Acetate 500 mg

Glenmark has also disclosed approvals in oncology-related generics. A company note dated May 20, 2022, stated that Glenmark Pharmaceuticals Inc., USA, received final approval by the USFDA for Abiraterone Acetate Tablets USP, 500 mg. The company described it as the generic version of Zytiga Tablets, 500 mg, of Janssen Biotech Inc.

A PTI report from New Delhi on May 20 also stated that Glenmark’s US arm received final approval for its generic version of Abiraterone Acetate tablets used for the treatment of prostate cancer, again specifying strength of 500 mg and the reference product Zytiga 500 mg.

In addition to the approval, Glenmark stated that its current portfolio consists of 173 products authorised for distribution in the US marketplace and 49 abbreviated new drug applications pending approval with the USFDA.

Another Abiraterone filing referenced a different strength

In another referenced item, Glenmark Pharmaceuticals said it had been granted final approval by the USFDA for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga Tablets, 250 mg. That update cited IQVIA sales data for the 12-month period ending August 2019 and stated the Zytiga 250 mg market achieved annual sales of approximately $194.1 million, which is about USD 79.41 crore when normalised.

That disclosure also mentioned a different snapshot of Glenmark’s US base: a portfolio of 162 products authorised for distribution in the US marketplace and 46 ANDAs pending approval with the USFDA. The stock was cited as trading 0.15 percent higher at ₹286.00 apiece on the BSE in that report.

Tentative ANDA for psoriasis foam

Glenmark also said its US-based arm received tentative approval from the US health regulator for a dermatology product used to treat psoriasis. The tentative approval is for Calcipotriene and Betamethasone Dipropionate foam of strength 0.005 percent/0.064 percent.

The company described it as the generic equivalent of Leo Pharma AS’ Enstilar foam. The update was positioned as another step in building the US pipeline, with tentative approvals typically linked to final approvals that can follow, subject to remaining requirements.

Earlier FY22 financial snapshot cited in disclosures

Some of the cited material also included an older quarterly financial snapshot. Glenmark’s consolidated profit after tax declined 26 percent to INR 173 crore for the fourth quarter ended March 31, 2022.

Consolidated revenues rose to INR 3,019 crore in the quarter under review compared with INR 2,860 crore in the year-ago period, an increase of 6 percent year-on-year.

These figures provide context alongside the more recent US regulatory updates, particularly because approvals can influence the cadence of launches and product mix over time.

Key numbers and timeline

Why these updates matter for investors

USFDA approvals and tentative approvals are closely tracked because they can expand the addressable product basket in the US, including OTC categories and complex or competitive therapeutic areas. Glenmark’s disclosures also highlight how the company continues to add products across different dosage forms, from ophthalmic solutions to combination analgesic tablets and oncology generics.

The excerpts also show that Glenmark has periodically disclosed its US portfolio size and pending ANDA count, with figures including 173 authorised products and 49 pending ANDAs in one update, and 162 authorised products and 46 pending ANDAs in another. While these snapshots are from different periods, they indicate that the US business has remained a central focus in company communication around regulatory milestones.

Closing note

Glenmark Pharmaceuticals’ recent stock moves, as cited, came alongside announcements of final USFDA approvals and a tentative ANDA, with investors also referencing past performance metrics such as the FY22 quarterly revenue and profit figures. Further market attention is likely to remain on the company’s subsequent regulatory updates and any launch-related disclosures tied to these approvals.