Mumbai 20th December, 2024: Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc.
Divalproex Sodium is an anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures. Refer label for a detailed indication.
Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA.
Alembic has a cumulative total of 220 ANDA approvals (193 final approvals and 27 tentative approvals) from USFDA.
Next post
Celebrate Love: Win a ₹1 Lakh Proposal Ring in Aukera Jewellery’s “Lock Your Love” Contest
More Stories
Odysse Electric wraps up 2025 on a firm note with December sales of 990 units
Mumbai, Jan 01st: Odysse Electric Vehicles, one of India’s fastest-growing premium EV manufacturers, posted a strong 133% year-on-year growth in December 2025, with sales rising to 990 units from...
Realty Vision: Dheeraj Sharma Takes the Helm as CEO of GHD Group
Gurugram, Jan 01: GHD Group, a leading real estate developer known for delivering quality residential and commercial projects especially in...
PayNearby’s Anand Kumar Bajaj Highlights December UPI Surge as Proof of Structural Shift and Growing Trust in India’s Real-Time Payments Ecosystem
Akash Sinha, CEO & Co-founder, Cashfree Payments“The December UPI numbers are a powerful indication of what the Indian payments ecosystem has collectively built...
Indian Furniture & Interiors Industry in 2025: A Year of Material Innovation and Consumer-Centric Design
As 2025 comes to a close, the Indian furniture and interiors industry has undergone a noticeable shift from décor-led decisions to material-driven choices rooted in durability, safety, and long-term...
Mr. Anand Mahindra’s End of the Year Address
A Year of Market Leadership and Redefined ExpectationsBusiness-wise, it has been a deeply satisfying year, not just because the numbers were strong, but...
India’s 2025 Free Trade Agreements and Export Missions: Unlocking Export Opportunities and Market Access, says PHDCCI
As the year 2025 draws to an end, India’s export policy landscape reflects a pivotal change toward global integration. Launch of the Market Access Support (MAS) Intervention under...