Lupin arm Dabhasa facility gets GMP certification from TGA Australia

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-07-18 06:08 GMT   |   Update On 2025-07-18 06:08 GMT
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Mumbai: Global pharma major Lupin Limited has announced that the API manufacturing facility of its wholly owned subsidiary, Lupin Manufacturing Solutions (LMS), in Dabhasa, Gujarat, has received the Good Manufacturing Practice (GMP) certification from the Therapeutic Goods Administration (TGA), Australia’s medicines and medical devices regulator.

Lupin Manufacturing Solutions offers pharmaceutical CDMO services and is engaged in the manufacturing and supply of APIs.

“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,” said Dr. Abdelaziz Toumi, Chief Executive Officer, Lupin Manufacturing Solutions. “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.”

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This week, Lupin has also launched Loteprednol Etabonate Ophthalmic Suspension, 0.5%, in the United States, following United States Food and Drug Administration (USFDA) approval last year. Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of steroidresponsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. It is also indicated for the treatment of post-operative inflammation following ocular surgery.

Read also: Lupin rolls out Loteprednol Etabonate Ophthalmic Suspension, 0.5% in US

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

Lupin Manufacturing Solutions specialises in manufacturing and supplying cost-effective Active Pharmaceutical Ingredients (APIs) and are the “Partner of Choice” in the Contract Development and Manufacturing Operations (CDMO) space for Drug substance.

Read also: Lupin, Zentiva ink pact to commercialize arthritis drug Certolizumab Pegol



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