Pharma Industry

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.

In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to begin laboratory testing immediately after filing applications instead of waiting for detailed scrutiny. In an official circular, the country's apex drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), said it has decided that "No Objection Certificate (NOC) for testing of drug samples at the designated laboratories (IPC, Ghaziabad; CDTL, Mumbai; CDL at CRI, Kasauli; or NIB, Noida) shall be issued immediately upon receipt of applications in the concerned division." Earlier, the regulator examined detailed specifications submitted by applicants before issuing permission for testing. These included "Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product," along with "Product development reports, forced degradation studies, and other relevant data, in ...

At the IPA summit, pharma leaders said India's 2047 ambitions depend on embedding AI, strengthening trust and accelerating innovation, as speed and quality become the sector's defining advantages

India's drug regulator is withdrawing export NOC requirements for SRA markets and easing other low-risk approvals, even as it strengthens oversight of manufacturing quality

Morepen Laboratories said supplies under the contract are expected to begin within the next four to five months, while execution is scheduled through the first quarter of the financial year 2026-27

Aurobindo Pharma is looking to ramp up the production of Penicillin-G to over 10,000 metric tonnes on an annual basis over the next 12 months, according to company CFO S Subramanian. The Hyderabad-based drug maker also expects its China-based manufacturing plant to break even in EBITDA in Q4 and meaningfully contribute to the bottom-line EBITDA in the next year. "The ramp-up of the facility (Pen-G) is progressing in line with expectations and is well-positioned to deliver a meaningful uplift in profitability over time. Based on our current production level, we expect to produce more than 10,000 metric tonnes on an annualised basis over the next 12 months," Subramanian told analysts in a call. The company's Pen-G facility, located in a SEZ at Kakinada in Andhra Pradesh, is expected to touch production capacity of 15,000 metric tonnes per annum over a period of time. "It is important to note that the yield levels are steady and improving consistently over time," Subramanian said. Th

Piramal Pharma has said the US health regulator has issued Form 483 with four observations after inspecting its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) conducted an inspection of the company's Digwal (Telangana ) based plant from February 9, 2026, to February 13, 2026. At the conclusion of the inspection, the USFDA issued a Form-483, with four observations, Piramal Pharma said in a regulatory filing on Friday. These observations are related to enhancement in procedures and not related to data integrity and indicated to be classified as a VAI (voluntary action indicated), it added. The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines, the drug maker stated. Piramal Pharma remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all the observations, it added. As per the USFDA, Form 48

ECDS, a company specialised in sustainable development technologies, on Wednesday announced it will set up a medical equipment manufacturing unit in Ujjain with an initial investment of Rs 780 crore under a joint venture with three South Korean companies. According to the company, this will be its first factory in India. "We have submitted a proposal to the state government to set up a unit on 15.60 acres of land in the Medical Equipment Park in Vikram Udyogpuri, Ujjain, of which we have already acquired 1.5 acres. This will be our first unit in the country," said Rajesh Bharadwaj, director of ECDS's Indian branch. He said construction will begin this year with an initial investment of Rs 780 crore, and the first phase of production will start by April 2027. "In the first phase, efforts will be made to provide employment to approximately 500 people," Bharadwaj told reporters in Indore. He said ECDS has partnered with three South Korean companies in a 50:50 joint venture to impleme

After a three-year strategic pause, diagnostics firm is unlocking its balance-sheet capacity look for growth-boosting acquisitions

Industry says approval delays, weak clinical trial infra holding back sector

Pharma-focused Budget 2026 measures could help India move beyond generics by boosting biologics, biosimilars, regulatory capacity and early-stage innovation, analysts say

India's pharmaceutical exports to the US are unlikely to see major tariff changes under the interim pact as Section 232 investigations continue, though medical devices may gain from better access

A customs duty exemption on select high-cost cancer and rare disease therapies is expected to lower treatment costs for patients while supporting demand for multinational and domestic pharma companies

The Budget recognises that innovation must translate into tangible benefits for patients

The Budget reframes healthcare as a strategic national capability, backing biopharma innovation, workforce expansion and technology-led governance to power India's next growth phase

Finance Minister Nirmala Sitharaman announced Mission Biopharma Shakti in the Budget, a five-year ₹10,000 crore programme to build domestic capabilities in biologics, biosimilars and clinical research

US generics remain under pressure while API revenues decline during the quarter

Biocon has opened a ₹4,500-crore QIP and fixed a floor price of ₹387.74 per share. The company said it may offer a discount of up to 5% and will finalise pricing with lead managers

Abbreviated new drug application filings have declined to 600 in the financial year 2025 (ending in September) versus 740 in the preceding year, Nomura said

With India importing about 70 per cent of its medical devices, the Department of Pharmaceuticals has invited proposals under two sub-schemes to reduce import dependence and support clinical studies