Generic Drugs

Indian companies filed 184 Type II DMFs with the US FDA in Q1 2026 against China's 149, reinforcing the country's leadership in API manufacturing and future generic drug development

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic version of cancer treatment drug Binimetinib tablets. The tentative approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Binimetinib tablets of strength 45 mg, Alembic Pharmaceuticals said in a regulatory filing. Based on USFDA's paragraph IV certifications list, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg and upon final approval of this ANDA by the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the US, the company said. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg, it added. Binimetinib in combination with encorafenib is used for the treatment of patients with unresectable or metastatic melanoma with resistance to specific targeted therapies in cancer. It is also indicated, in combination

The company has launched a generic version of Pfizer's Bosulif for chronic myeloid leukaemia and secured 180 days of exclusivity for the 400 mg strength

Cipla's March 2026 quarter revenue is expected to decline marginally to ₹6,665 crore as compared to ₹6,730 crore in the year-ago period

With cheaper GLP-1 pills entering India, access could improve significantly, but experts warn that affordability must be balanced with strong regulation and patient safety

Brazil's regulator Anvisa rejects DRL and Cipla's generic GLP-1 drug filings, citing unmet technical requirements on efficacy, safety and quality

Mounjaro sales in March dropped to ₹114 crore ($12.3 million) in March from ₹135 crore a month earlier, Pharmarack data show

Regulators have been asked to track adverse events as India tightens oversight on popular obesity drugs amid rising demand and concerns over misuse and misleading promotions

Duties for products made by certain larger companies will take effect in 120 days, while items from smaller manufacturers won't be hit for another 180 days, according to a White House statement

Pharma major Lupin Ltd on Tuesday said it has received tentative approval from the US health regulator for its generic version of Sugammadex injection used for reversing the effects of muscle relaxants given during surgery. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial, Lupin said in a regulatory filing. The USFDA has tentatively approved Lupin's Sugammadex injection of the specified strengths as bioequivalent to Merck's Bridion injection, it added. It is used for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.

A study has found a new biomarker of schizophrenia, which could also serve as a drug target for treating cognitive symptoms such as disorganised thinking or executive function. Schizophrenia is a mental health disorder marked by an impaired ability to perceive and interpret reality and can involve delusions and disorganised thinking, or cognitive symptoms. Researchers from the US' Northwestern University said that schizophrenia medications treat symptoms such as hallucinations and delusions, but do little for cognitive symptoms. "A lot of people with schizophrenia cannot integrate well into society because of these cognitive deficits," author Peter Penzes, professor of neuroscience, pharmacology and psychiatry and behavioral sciences at Northwestern University's school of medicine, said. "Our discovery could solve these challenges by establishing the basis of a revolutionary and completely novel treatment strategy through a tandem biomarker-peptide therapeutic approach," Penzes ...

Off-patent GLP-1 therapy drives 70-90% price drop with generics flooding in

Drugmaker expects to receive regulatory approval for weightloss sema generic in a few months

Aurobindo Pharma subsidiary Eugia Pharma has launched generic Pomalidomide Capsules in the US, one of the first-to-file applicants for the drug, expanding its oncology portfolio

Glenmark Pharmaceuticals on Friday said its US-based unit is gearing up to introduce a generic sodium phosphates injection in the American market. The Mumbai-based drug firm said its product is therapeutically equivalent to Hosira Inc's reference listed drug. Glenmark will begin distribution of the injection in the US market in April 2026, it said in a regulatory filing. According to IQVIA, sales data for the 12-month period ending December 2025, the Sodium Phosphates Injection USP single-dose vials saw annual sales of around USD 66.8 million. Shares of the company were trading 0.82 per cent up at Rs 2,144.50 apiece on BSE.

Sun Pharmaceutical Industries expects pressure on its US generics business to ease as compliance improves, while focusing growth efforts on innovation-led therapies

Analysts say the US move to link drug prices to the lowest global benchmarks targets patented medicines, limiting near-term risks for India's largely generic-focused exporters

NMC has asked medical colleges to set up sub-committees to monitor prescription practices and stress clear, legible handwriting as part of medical training.

Health Canada's non-compliance notice may delay DRL's semaglutide generic launch by 8-12 months, say analysts; shares fall over 4 per cent on Thursday

The announcement comes a day after Lupin said the US FDA had inspected its Nagpur injectable facility between September 8 and 16, issuing six observations