Lupin Limited, a key player in the global pharmaceutical landscape, has declared that it obtained the green light from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). This milestone covers the production of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules—collectively known as mixed salts of a single entity amphetamine product. These come in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg doses as a generic counterpart to the Adderall XR extended-release capsules from Takeda Pharmaceuticals USA, Inc. Lupin’s US facility in Somerset will handle its manufacturing.
The capsules are designated for treating attention deficit hyperactivity disorder (ADHD) in both adults and children aged six and above.
The Reference Listed Drug (RLD) Adderall XR recorded estimated sales of USD 865 million annually in the United States, according to IQVIA data from September 2024.
Based in Mumbai, India, Lupin Limited stands as a dominant force in the pharmaceutical industry, supplying its innovative range of products to over 100 regions globally. Its specialties span across branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
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