JB Chemicals’ Gujarat API Facility Clears USFDA Inspection With Zero Observations

17 Mar 2025 , 10:07 PM

JB Chemicals & Pharmaceuticals Ltd said its Active Pharmaceutical Ingredients (API) manufacturing facility (D9) in Panoli, Gujarat, was successfully inspected by the US Food and Drug Administration (USFDA) when no observations were made.

The inspection was conducted from March 10 to March 13 of 2025 at Plot No. 5, GIDC, Panoli, Gujarat facility. The inspection was completed with no 483 observations, demonstrating total compliance with the USFDA standards.

The company reiterated its focus on quality manufacturing practices:

• The company reaffirmed its commitment to quality manufacturing practices, focusing on:
• Embedding a strong quality culture across the organization
• Continuous investment in systems and processes
• Employee training initiatives to maintain high standards of quality and regulatory compliance.

In its financial performance for Q3 FY25 (October-December 2024), JB Chemicals reported:

• 21.6% YoY increase in net profit, reaching ₹162.5 crore compared to ₹133.6 crore in Q3 FY24
• Revenue from operations surged 14.1% to ₹963.5 crore, up from ₹844.5 crore in the corresponding period last year
• EBITDA grew by 14.1% to ₹254.5 crore from ₹223.1 crore YoY
• EBITDA margin remained stable at 26.4%, unchanged from the year-ago quarter

EBITDA (Earnings Before Interest, Tax, Depreciation, and Amortization) is a key financial metric indicating the company’s operating performance. The successful USFDA clearance further strengthens JB Chemicals’ position in the global pharmaceutical market, ensuring continued exports to the US.