About Ascend Laboratories

Ascend Laboratories is a U.S.-focused generic pharmaceutical company that develops, manufactures and markets off‑patent medicines for hospitals, pharmacies and wholesalers, leveraging both in‑house R&D and parent‑company resources to supply over 100 SKUs to the market. [1][3] Founded in the early 2000s as a product‑development specialist for generic drug makers, Ascend transitioned from a support role into direct commercialization after acquiring sales and marketing capabilities and obtaining its own FDA approvals; its first labeled products launched in 2008.[1] Ascend then pursued a bifurcated strategy of organic internal development plus partnerships with firms that could secure FDA approvals but lacked U.S. commercialization expertise.[1] That partner strategy led to a strategic integration with India’s Alkem Laboratories, and Ascend now operates as a wholly owned subsidiary that draws on Alkem’s R&D, manufacturing scale and infrastructure.[1][3] Ascend’s manufacturing and development footprint spans the U.S. and India: U.S. sites in California and Missouri produce APIs and finished dosage forms while Indian campuses (Daman and Baddi) host general formulation lines plus specialized blocks (penicillin, cephalosporin, immunosuppressants); the parent group supports two R&D centers in India employing hundreds of scientists, including PhDs.[3][5] Ascend reports 23 U.S.-approved molecules on the market, more than 100 marketed SKUs, 54 submitted molecules awaiting FDA decisions, and 100+ candidates in development.[3] Notable achievements include transitioning from a small product‑development shop to an FDA‑approved label holder, integrating with a major Indian pharma to scale manufacturing and pipeline, and building a vertically integrated capability that includes a CRO and biostudy hospital to support bioequivalence work.[1][3] Ascend emphasizes cost‑saving generic alternatives, FDA

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Atorvastatin Recall Triggers Patient Concern: FDA Oversight and Global Supply Chain Risks

15 Dec 2025 36 views

#health #pharma #recall #fda #global_supply_chain

Massive recall of atorvastatin due to dissolution failures raises FDA oversight and global supply chain concerns.