Zydus Lifesciences Receives USFDA Approval to Produce Niacin Tablets
Zydus Lifesciences Ltd. announced that the US health agency, US Food and Drug Administration (USFDA), has given it final approval to produce the generic form of Niacin extended-release tablets, which decrease cholesterol.
Zydus Lifesciences Ltd. states that the USFDA had approved Niacin extended-release tablets with strengths of 500 mg, 750 mg, and 1,000 mg.
According to the company, the group's production facility in Moraiya, Ahmedabad, will create the niacin extended-release pills.
In patients with primary hyperlipidemia and mixed dyslipidemia, niacin is recommended to raise HDL cholesterol (HDL-C) and decrease high triglycerides (TG), LDL cholesterol (LDL-C), apolipoprotein B (Apo B), and total cholesterol (TC).
Furthermore, Zydus and Amplitude Surgical SA ("Amplitude") signed off on the completion of the required information gathering and consultation procedure with Amplitude SAS's works council.
After that, Zydus negotiated a share purchase agreement with PAI Partners, Olivier Jallabert, and other Amplitude managers to buy 75.4 percent of the company's share capital at a price of 6.25 euro per share.
Together with the two share purchase agreements with two minority shareholders that were completed on March 11, 2025, this transaction accounts for 85.6 percent of Amplitude's total share capital.
The Autorité des Marchés Financiers ("AMF") will thereafter receive Zydus' required simplified tender offer. There will be a squeeze-out process if the requirements are satisfied.
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The strategic growth of Zydus Lifesciences, which is anticipated to be finished by Q3 2025, has taken a major stride with this acquisition.