Page 4 - Sun Pharma

Sun Pharma, Lupin, Dr Reddy's recall products in US due to mfg issues

Domestic drug majors Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling drugs in the US market due to manufacturing issues and product mix up, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US. Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to "Failed Dissolution Specifications", the US health regulator stated. The medication is used to treat attention deficit hyperactivity disorder (ADHD). The drug firm initiated the Class II recall in the US on June 16 this year, it added. Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure. Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets (US

Sun Pharma resolves US antitrust case with $200 mn agreement

Sun Pharmaceutical Industries on Thursday said it has settled an antitrust litigation in the US entailing a payment of USD 200 million. The subsidiaries of the company, Sun Pharmaceutical Industries, Inc. (SPII) and Taro Pharmaceuticals USA, Inc. have signed a settlement agreement with the End Purchaser Plaintiffs in the In re Generic Pharmaceuticals Pricing Antitrust Litigation in the Eastern District of Pennsylvania, US, the Mumbai-based drugmaker said in a regulatory filing. "Under the terms of the settlement agreement, the subsidiaries will make an aggregate payment of USD 200 million in exchange for a full release of all claims asserted against them in the End Purchaser Action by the settlement class members," it added. The settlement amounts may be reduced if more than a certain percentage of the total insured class members opt out of the putative class, the company stated. The settlement agreement is subject to court approval, it added.

Results preview: Pharma firms stare at muted earnings growth for Q1

Indian pharma firms are set to post modest Q1FY26 earnings, with Revlimid erosion impacting US revenues and domestic growth moderating in chronic therapies

Sun Pharma's psoriasis drug delivers positive results in arthritis trials

Phase 3 trials show ILUMYA improved PsA symptoms significantly, with no new safety concerns; results support potential regulatory submissions in the US and globally

Sun Pharma gains on US launch of Leqselvi, analysts see strong upside

Sun Pharma rises 2.7% as it launches Leqselvi in US following settlement with Incyte, with analysts projecting $200-300 million revenue from the drug in 3-5 years

Sun Pharma shares rise 2% on US launch of hair loss drug after settlement

Sun Pharma shares rose nearly 2 per cent on Tuesday after the company launched Leqselvi, a new treatment for severe alopecia areata

Sun Pharma launches Leqselvi in US after patent settlement with Incyte Corp

Sun Pharma will pay Incyte an upfront fee and royalties to market Leqselvi in the US for alopecia areata until patent expiry in FY26 following a litigation settlement

Sun Pharma launches hair loss drug Leqselvi in US after patent settlement

The delay in Sun Pharma's launch of Leqselvi in the US was caused by a patent infringement case, which was later settled in a US court with Incyte Corp

Price pressures to intensify for drugmakers, says Sun Pharmaceutical

Sun Pharma expects global pricing strain due to policy shifts, as FY25 US sales rise 5.8% despite compliance challenges; specialty business lifts overall growth

Sun Pharma partner Philogen withdraws EU application for skin cancer drug

Experts believe that the drug still holds potential for future market entry, and the current development should be viewed as a temporary setback

Abbott, MSD join hands to distribute key diabetic drug across India

Abbott to distribute MSD's sitagliptin portfolio-Januvia, Janumet, Janumet XR-in India, targeting deeper reach in the ₹950-1,000 crore diabetes drug segment

Sun Pharma share slips 2% as USFDA flags 8 observations for Halol facility

Sun Pharma shares dropped in trade after the company announced that United States Food and Drug Administration (USFDA) has issued a Form-483, with 8 observations for its Halol facility in Gujarat.

Sun Pharma's Halol plant gets 8 USFDA observations post inspection

Drug major Sun Pharma on Saturday said the US health regulator has issued a Form 483 with 8 observations after inspecting its Halol (Gujarat) manufacturing plant. The US Food and Drug Administration (USFDA) conducted a good manufacturing practices (GMP) inspection at the Halol facility from June 2-13 2025, the Mumbai-based drug maker said in a regulatory filing. At the conclusion of the inspection, the USFDA issued a Form-483 with 8 observations, it added. As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Sun Pharma starts succession plan; Ganorkar succeeds Shanghvi as MD

Dilip Shanghvi to remain executive chairman while Ganorkar takes charge as MD from September 1 and Aalok Shanghvi is given additional charge of North America business

Sun Pharma appoints Kirti Ganorkar as MD after shareholders' approval

Gonarkar has been heading Sun Pharma's India business since 2019 and has previously held roles in marketing, new product introduction, among others, within the company

Sun Pharma halts development of SCD-044 drug after trial disappointment

Sun Pharma discontinues work on its experimental skin drug SCD-044 after Phase 2 trial results fall short of goals for treating psoriasis and atopic dermatitis

Sun Pharma lines up $100 mn to commercialise niche products in FY26

Sun Pharmaceutical Industries has lined up a USD 100 million investment to commercialise innovative products in the current fiscal, according to Chairman and Managing Director Dilip Shanghvi. The Mumbai-based drug major said the capital outlay will help in significantly strengthening the company's speciality (patented products) business for the future. "For the current year, we are looking to invest approximately USD 100 million additionally on the commercialisation of new speciality products," Shanghvi told analysts in a call. The drug major plans to majorly invest in the launch of two products -- Unloxcyt and Leqselvi. Unloxcyt is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma, while Leqselvi is for the treatment of adults with severe alopecia areata. In FY25, the company's global speciality sales rose 17.1 per cent to USD 1,216 million. In the January-March quarter of FY25, the sales were up 8.6 per cent to USD 295 million. Elaborating

Sun Pharma to invest $25 million in Pharmazz Inc; raises stake to 22.7%

The company noted that the initial $10 million tranche, along with $7.5 million from the second SAFE tranche, will be invested by or before May 31, 2025

Weak guidance, higher costs to weigh on Sun Pharma's FY26 outlook

Sun Pharma's FY26 revenue guidance disappoints Street expectations as higher specialty product costs in the US prompt brokerages to cut earnings estimates

Sun Pharma share price slips 5% after Q4 results; check key numbers here

Sun Pharma share price dropped after the company posted a mixed bag of results in the March quarter of financial year 2025 (Q4FY25).