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    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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    Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

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    Last Updated on PharmaCompass Virtual Booth Country Name of the Firm Written Confirmation No. Product Name Issue Date Valid Till Address of the Firm
    17/01/2026 Alkem Laboratories
    India
    		 M/s Alkem Laboratories Ltd WC-0385 Lisdexamfetamine Dimesylate IH 2025-09-24 2028-09-23 Survey No. -85 to 88, N.H. No. 8, Naugama,At & Post-Mandva, Tal. -Ankleshwar, Dist.-Bharuch -393010, Gujarat, India
    01/12/2025 Embio Limited
    India
    		 M/s Embio Limited WC-0046 Lisdexamfetamine Dimesylate IH 2025-08-08 2028-07-28 E-21, MIDC, Indt. Estate, Mahad-402 309, Taluka: Mahad, District: Raigad, Maharashtra, India\r\n
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