| |NOVEMBER 20259GRANULES PHARMACEUTICALS RECEIVES POSITIVE USFDA REPORTHOMEGROWN BIOTECH BOOSTS AFFORDABLE NEXT-GEN CANCER DRUGSIndia pharmaceutical industry is going next-generation cell and gene therapy decisively, inspiring cancer treatment accessibility at a lower cost. Last year landmark regulatory nods for two in-house CAR-T innovations one by ImmunoACT out of Mumbai and the other by Immuneel Therapeutics from Bengaluru have signaled India's arrival in one of the most technically challenging areas of healthcare.The price of such therapies, which involve the genetic modification of the patient's immune system to attack the tumor, has been anywhere from 30 to 50 lakh per patient, practically ruling out the vast majority of patients.The Indian pharma and biotechnological companies are now making a tactical move by venturing into Cell and Gene Therapy Contract Research, Development, and Man-ufacturing (CRDMO). Bharat Biotech, the company which successfully indigenized the production of COVID-19 vac-cine in India, has unveiled Nucelion, a focused unit for ad-vanced cell and gene therapy CRDMO, after similar proj-ects by Syngene, Laurus Labs, and Aragen.According to the experts, local innovation and production can bring down the prices substantially while clinical timelines might also get shorter along with the possibility of local supervision. The NexCAR19 by ImmunoACT, which was achieved by collaboration with IIT Bombay and Laurus Labs, is a shining example of how high-quality, indigenously produced CAR-T therapy can be a game-changer in terms of cost, as compared to those in the West where the same treatment can be as expensive as $400,000 per patient.India's cell and gene therapy market worth $1.65 billion by 2027, with a CAGR of 18.1 percent, alongside the support from BIRAC, ICMR, and other such agencies creates a perfect environment for local innovation to democratize the access of advanced therapeutic modalities.This move by Bharat Biotech might be the first push that can set the scene for mass production of next-gen cancer and genetic disorder therapies in India at a price that patients can afford, thus making the treatments not only viable but also accessible. POGranules India Ltd. announced that the USFDA has issued an Establishment Inspection Report (EIR) for Granules Pharmaceuticals, Inc., a wholly-owned subsidiary of Granules India Ltd. in Chantilly, Virginia. The report was issued after a Pre-Approval Inspection (PAI) held in June 2025.The inspection was performed as a result of Granules' first-to-file Abbreviated New Drug Application (ANDA) for a controlled substance, which is the company's path-breaking move in its expansion of the U.S. pharmaceutical market.As part of the PAI, the USFDA identified only one ob-servation in the Granules response. After it was contacted by the Granules team, the observation was resolved. This finding's resolution evidences the company's compliance framework, manufacturing operations, and their commit-ment to regulatory standards of the US market.The commendable check by USFDA is a prerequisite for the controlled substance ANDA first-to-file with final approval, and thus enhancing the company's presence in these regulated markets aligns with the secured strategy.Granules on the other hand, given the authorization, propels itself to promote the availability of quality medications at an affordable price in the U.S. market as well, thereby, solidifying its global stature as a reliable pharmaceutical manufacturer.Granules achieving the USFDA inspection culminated in the issuance of a clean EIR, thereby proving the company's resolve toward regulatory excellence, operational integrity, and the manufacture of quality drugs for patient needs.The controlled substance segment expansion will provide this company with prospects for growth and long-lasting regional value generation within the rigorous U.S. pharmaceutical landscape. PO
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