| |NOVEMBER 20258VENUS REMEDIES GAINS NEW DRUG APPROVALS IN VIETNAMLUPIN'S PITHAMPUR UNIT-3 SECURES US FDA EIR APPROVALLupin Limited, a global pharmaceutical company, has received the Establishment Inspection Report (EIR) of the Lupin Pithampur Unit-3 plant in Madhya Pradesh.This report is a follow-up to a successful inspection conducted between July 7 and July 17, 2025, and is a milestone regulatory requirement to the company.Pithampur Unit-3 plant plays a central role in the global supply chain of Lupin since it produces metered dose inhalers, dry powder inhalers, topical formulations and nasal solutions to several different markets.Commenting on the development, Nilesh Gupta, Managing Director of Lupin, said, "We are pleased to have received the EIR from the US FDA for our Pithampur Unit-3 facility. This demonstrates our commitment to maintaining the highest standards of compliance and quality, as we aim to deliver high-quality, affordable medicines from world-class factories for patients worldwide."The EIR confirms that the facility has been able to achieve the necessary quality and compliance standards required by the FDA, which would make Lupin a reputable global supplier. Headquartered in Mumbai, India, Lupin Limited is one of the most reputable pharmaceutical firms in the world and its products are sold in over 100 markets.The portfolio of the company consists of branded and generic formulae, complex generics, biotechnology products and active pharmaceutical ingredients (APIs). The US FDA EIR enhances US FDA Lupin; concentration on regulatory excellence combined with its operational integrity that are two important pillars behind the Lupin expansion program in a competitive international pharmaceuticals environment. POTOP STORIESVenus Remedies, one of the world's top 10 manufacturers of fixed-dosage injectable drugs, has received new marketing authorizations in Vietnam for three key products methotrexate, cefuroxime, and irinotecan. These latest approvals strengthen the company's growing presence in South Asia's dynamic pharmaceutical market, bringing its total number of active product registrations in Vietnam to 29.The new authorizations highlight Venus Remedies' expanding role as a trusted Indian supplier of high-quality critical care injectables. With over 374 marketing approvals already secured across the ASEAN region, the company continues to enhance the availability of advanced therapies while reinforcing India's reputation as a dependable source of pharmaceuticals.Commenting on the development, Saransh Chaudhary, President of Global Critical Care at Venus Remedies and CEO of Venus Medicine Research Centre, stated, "Our expansion reflects a steadfast commitment to making advanced critical care treatments accessible in emerging markets. Southeast Asia is a key focus for us, and we aim to strengthen our presence through continuous product diversification and sustainable collaborations."Vietnam, currently India's 15th largest trading partner and one of its top four pharmaceutical destinations in Southeast Asia, has witnessed steady growth in bilateral pharmaceutical trade over the past five years.This growth is driven by rising demand for complex generics, oncology solutions, and antimicrobial therapies. With the ASEAN pharmaceutical market expected to reach USD 63.5 by 2029, the region remains an essential pillar of India's global pharmaceutical trade strategy. PO
< Page 7 | Page 9 >