Lupin's arm receives GMP certification from Australia's TGA

Business Standard

3 days ago

Lupin announced that its wholly owned subsidiary, Lupin Manufacturing Solutions (LMS), has received GMP certification from the Therapeutic Goods Administration (TGA), Australia's regulatory authority for medicines and medical devices.
The certification applies to LMSs active pharmaceutical ingredient (API) manufacturing facility in Dabhasa, Gujarat. LMS provides pharmaceutical contract development and manufacturing organization (CDMO) services, focusing on the production and supply of APIs.
Dr. Abdelaziz Toumi, chief executive officer, Lupin Manufacturing Solutions. We are pleased to have received the GMP certification from TGA for our Dabhasa facility. This reflects the high standard of our manufacturing practices and expertise of our team at Dabhasa, As we continue to expand our global footprint, we remain focused on quality, compliance, and the highest standards of operational integrity, setting new benchmarks in the CDMO space.
Meanwhile, the company notify that the U.S. FDA inspected Lupins Pithampur Unit-3 manufacturing facility from July 07 to July 17, 2025. The inspection closed with the issuance of a Form-483 with three observations. We will address the observations and collaborate with the U.S. FDA to resolve them within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities.
In other regulatory updates, Lupin disclosed that the U.S. Food and Drug Administration (FDA) conducted inspections at its Pithampur manufacturing facilities. The inspection of Pithampur Unit-3 took place from 7 July to 17 July 2025, resulting in a Form-483 with three observations. Similarly, the Pithampur Unit-2 facility was inspected from 8 July to 17 July 2025, with four observations noted in the Form-483.
The company confirmed that it is actively addressing all observations and will work closely with the U.S. FDA to resolve them within the stipulated timeframe. Lupin reaffirmed its commitment to maintaining compliance with current Good Manufacturing Practice (CGMP) quality standards across all its manufacturing units.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, 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.
The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24.
The scrip shed 0.94% to Rs 1,937 on the BSE.