Granules India shares gained 1.69% to close at ₹789.95 on Wednesday, June 3, following positive regulatory developments from its US subsidiary. According to reports from Business Standard, the stock movement reflects continued investor confidence in the company's regulatory compliance progress. The stock has gained more than 27% so far this year, demonstrating strong market sentiment toward the company's regulatory achievements. However, as per ET Now, shares were trading at ₹783.40, down 1.20% from the previous close at 9:28 AM on the BSE.
The company's US arm, Granules Pharmaceuticals Inc. (GPI), located in Chantilly, Virginia, US, received an Establishment Inspection Report (EIR) from the USFDA with a Voluntary Action Indicated (VAI) classification for its Virginia facility. As reported by Business Standard, the USFDA conducted an inspection from March 30 to April 3, 2026, and issued four Form 483 observations during the inspection period. The VAI classification indicates that while certain observations were made, they do not warrant any regulatory or enforcement action, indicating the successful closure of the inspection process.
Recent brokerage visits to Granules India's facilities at Gagillapur and Genome Valley have provided incremental comfort around remediation measures undertaken by the company following the September 24 USFDA inspection of the Gagillapur facility. According to Emkay's latest note, the brokerage noted improvements on three major fronts: adequate measures to prevent data breach, digitization initiatives with full implementation of a Manufacturing Execution System expected by the end of CY26, and structural changes in air handling units to limit cross contamination. The company remains committed to maintaining the highest standards of quality, safety and regulatory compliance across its manufacturing facilities in both India and the US.
Earlier this year, Granules India received tentative approval from the USFDA for its generic amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg for treatment of attention deficit hyperactivity disorder, with 180-day exclusivity eligibility. As reported by Business Standard, this follows a previous tentative approval on December 22, 2025 for amphetamine extended release orally disintegrating tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg. The company's Virginia facility remains an important part of its global manufacturing and supply network, supporting its focus on quality systems and regulatory compliance.
Emkay has maintained a Buy call on the pharma stock with a target price of ₹900, citing the company's progress on remediation measures and facility improvements. The brokerage expects the India R&D unit to drive peptide CDMO growth, with structural and process-level changes in air handling units to limit cross contamination scope. The company's strong financial performance with consolidated net profit climbing 32.58% to ₹201.56 crore and revenue from operations increasing 22.81% to ₹1,470.60 crore in Q4 FY26, along with its focus on quality systems and regulatory compliance, supports the positive brokerage outlook.
