SMS Pharmaceuticals Gains After USFDA Approval of Reformulated Ranitidine Tablets | Q2 Numbers Show Strong Growth

The mood around SMS Pharmaceuticals shifted quickly this week. A familiar drug—once at the centre of global safety conversations—made its way back to the US market. And this return came with a direct connection to SMS Pharma’s partner, VKT Pharma, earning USFDA approval for its reformulated Ranitidine tablets in 150 mg and 300 mg strengths.

The moment the update hit the market, the stock reacted instantly. What followed was a day of strong interest, heavy volumes, and a broader conversation about how the company is shaping its next phase.

This story brings together two threads—

The return of Ranitidine to the US market, and

SMS Pharmaceuticals’ sharp jump in Q2 performance.

Market Performance: Stock Reacts Strongly to Regulatory Update

The market rarely ignores a major regulatory milestone. SMS Pharmaceuticals’ stock opened strong and carried that energy throughout the session.

• Opening Price: ₹279.10
• Intraday High: ₹319.90
• Intraday Low: ₹279.05

While price movements often reflect sentiment, this surge was clearly tied to a development investors had been waiting to see—the USFDA bringing back a key acid-reducing medication through an approved reformulated version.

Main News: USFDA Approves Reformulated Ranitidine Tablets

The biggest trigger for SMS Pharmaceuticals came from the US Food and Drug Administration. The regulator has approved the reformulated Ranitidine tablets manufactured by its partner VKT Pharma.

Ranitidine has always been a widely used medication, especially for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcers
• Conditions linked to excess stomach acid

But after concerns around NDMA impurity surfaced years ago, the drug had been off the shelves in major markets. The new approval marks its return after nearly five years, backed by fresh safety evaluations and revised manufacturing controls.

What stands out is the nature of the approval. It follows:

• Safety assessments
• Revised processes to mitigate impurity risks
• Improved manufacturing standards

With this, an important acid-reducing medication re-enters the US market, improving patient access to a treatment that had been missing for years.

Company Details: Strong Q2 FY26 Performance Across All Key Metrics

While the approval took the headlines, SMS Pharmaceuticals had already delivered strong fundamentals in Q2.

The company reported a sharp jump in profitability, supported by better demand and improved efficiencies.

Q2 FY26 Financial Highlights

• Net Profit: ₹25.14 crore
  • Up from ₹14.25 crore
  • Increase: 76.4% YoY
• Operating Revenue: ₹242.4 crore
  • Up from ₹196.7 crore
  • Increase: 23.2% YoY
• EBITDA: ₹48.34 crore
  • Up from ₹31.85 crore
  • Increase: 51.8% YoY
• EBITDA Margin:
  • Current: 19.94%
  • Previous year: 16.19%

Summary: A Pivotal Moment for SMS Pharmaceuticals

The day brought together two powerful drivers:

1. USFDA approval of reformulated Ranitidine tablets, signalling the return of a widely used acid-reducing medication to the US market.
2. SMS Pharmaceuticals’ strong Q2 results, marked by a 76.4% surge in net profit and healthy double-digit growth across revenue and EBITDA.

With both regulatory progress and financial momentum, SMS Pharmaceuticals finds itself at an important point in its business cycle. The company’s improved margins, rising demand, and the clearance of a key drug have collectively shaped a better narrative for the quarter.