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Pharmaceuticals
USFDA5 Nov 2025, 06:01 pm

Lupin Ltd Receives EIR from U.S. FDA for its Pithampur Unit-3 Facility

AI Summary

Global pharma major Lupin Limited has announced receiving the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur Unit-3 facility. The facility, which manufactures metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions, underwent an inspection from July 7 to July 17, 2025. Nilesh Gupta, Managing Director, Lupin, expressed satisfaction, stating that this demonstrates the company's commitment to maintaining the highest standards of compliance and quality. Lupin Limited, headquartered in Mumbai, India, is a global pharmaceutical leader with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Key Highlights

  • Lupin Ltd receives EIR from U.S. FDA for its Pithampur Unit-3 facility.
  • The facility manufactures metered dose inhalers, dry powder inhalers, topical formulations, and nasal solutions.
  • The inspection by U.S. FDA took place from July 7 to July 17, 2025.
  • Lupin Limited is a global pharmaceutical leader with products in over 100 markets.
  • The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
LUPIN
Pharmaceuticals
LUPIN LTD.

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