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Akhilesh Jat SEBI RA

17th Mar 2025 · SEBI-Registered Analyst

Alkem Laboratories Passes US FDA Inspection, No Form 483 Issued

ALKEM
has recently undergone a Bioresearch Monitoring (BIMO) inspection by the US FDA at its Bioequivalence Center in Taloja, Maharashtra, from March 10-13. The inspection concluded without the issuance of a Form 483, indicating that no significant issues were found, further solidifying Alkem’s commitment to quality and compliance. In addition, Alkem Medtech, a subsidiary of Alkem Laboratories, has entered into a Share Purchase and Share Subscription Agreement with Bombay Ortho Industries to acquire a 100% stake in the company. This strategic acquisition strengthens Alkem’s presence in the medical technology sector, diversifying its portfolio and expanding its growth opportunities. These developments mark positive strides in both regulatory and business aspects for Alkem Laboratories. Disclaimer: This post is for informational purposes only and does not constitute investment advice.

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