LUPIN LIMITED

The global pharmaceutical CDMO market was valued at USD 184.90 billion in 2024 and is projected to reach USD 368.70 billion by 2034, driven by a CAGR of 7.2%. Key players include Pfizer, Biocon Biologics, and Thermo Fisher Scientific. Services offered by CDMOs include antibody production and vaccine development, operating under GMP and cGMP standards. The Asia Pacific region leads with a 42.4% market share, while Europe is expected to grow at a CAGR of 7.7%.

Increased R&D in myotonic dystrophy drives market growth, attracting funding and partnerships. DelveInsight's 'Myotonic Dystrophy Pipeline Insight 2024' reports on 20+ companies developing 22+ therapies, including AOC 1001, Tideglusib, and PGN EDODM1. Key events include FDA designations for ATX-01 and DYNE-101, and Fast Track designation for PGN-EDODM1.

Lupin receives FDA approval for generic Adderall XR, covering 5-30 mg extended-release capsules for ADHD treatment, with annual sales of $865 million in the U.S.

Lupin Limited received FDA approval for its ANDA of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, 5-30 mg, a generic equivalent of Adderall XR. The product treats ADHD in adults and children 6 years and older, with estimated annual US sales of USD 865 million.

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules, to be manufactured at its Somerset facility. The product is a generic equivalent of Adderall XR, indicated for ADHD treatment in adults and children 6 years and older, with estimated annual sales of USD 865 million in the U.S.

Lupin re-launches Humrahi at RSSDI conference, now offering comprehensive support for diabetes and heart health. Humrahi aims to improve patient outcomes through value-based care and education, accessible via app or toll-free number.

The Global Pharma 4.0 Market is projected to grow from US$ 11.9 Billion in 2023 to US$ 67.7 Billion by 2033, driven by digital transformation strategies, AI, IoT, and blockchain. Key segments include AI & ML leading technology with 33.4% share, drug discovery & development with 37.8%, and pharmaceutical companies as the dominant end-user with 42.6%. North America leads with 39.7% market share, while Asia Pacific is expected to grow fastest.

Lupin receives tentative U.S. FDA approval for Raltegravir tablets, potentially securing 180-day exclusivity for a generic version of Merck’s Isentress HD. The drug, manufactured at Lupin’s Nagpur facility, treats HIV-1 infection and is expected to impact the $36 million U.S. market.

Lupin's leadership anticipates strong double-digit growth in FY25, with India's robust market and diabetes segment recovery. The US business focuses on new product launches and sustained profitability, targeting a core margin of 23-25%.

Lupin receives tentative USFDA approval for Raltegravir Tablets, 600 mg, a generic equivalent of Merck's Isentress HD, to be manufactured at its Nagpur facility. The drug treats HIV-1 in adults and pediatric patients weighing at least 40 kg, with estimated U.S. sales of $36 million.