The US FDA inspection of Alkem's Taloja CRO facility on May 8, 2026, resulted in no Form 483 being issued, indicating that the facility complies with FDA standards and operates according to US regulations.

Pharmaceutical company Alkem Labs is currently undergoing an unexpected on-site evaluation by the U.S. Food and Drug Administration (FDA). This move indicates potential scrutiny over their manufacturing practices to ensure compliance with American regulations.

The US Food and Drug Administration (FDA) has identified seven potential issues at Alkem Lab's Daman facility. However, Alkem has committed to resolving these concerns. Notably, the facility had recently secured European Good Manufacturing Practice (EU GMP) compliance in December 2025.

Alkem Laboratories' Amaliya unit received seven observations during a recent FDA inspection (April 20-May 1, 2026). The company has acknowledged these findings and plans to address them promptly to ensure compliance with FDA regulations.

Alkem Labs faces seven regulatory issues from the US FDA following an inspection at their Daman facility, indicating areas for improvement in their manufacturing practices.

Alkem Labs is under a tax dispute worth approximately INR 333.4 crore, but the company may not face immediate financial strain due to the utilization of Minimum Alternative Tax (MAT) credits that offset potential liabilities.

The CEO of Alkem Labs, Vikas Gupta, announced his resignation effective June 30, 2026. Despite a successful run over the past year with a 0.7% stock increase, his departure has led to a 5.2% drop in Alkem's shares on NSE, possibly due to market volatility within the pharmaceutical sector. The company is ensuring a smooth transition of leadership during this time.

Dr. Vikas Gupta steps down as Alkem Labs CEO, seeking fresh ventures. He plans to stay onboard until June 2026 to ensure a seamless transition period.

Alkem Labs' share price has dipped due to the departure of CEO Vikas Gupta, who is pursuing fresh endeavors elsewhere. This news may lead investors to question potential leadership changes and their impact on the company's future.

Indian pharmaceutical company Alkem Labs has established a new trading entity, Alkem Pharma Trading FZCO, in Dubai with an initial capital of AED 3.7 million. This move aims to expand global exports, particularly focusing on African, Southeast Asian, and non-UAE markets.

ICICI Securities predicts a moderate 7.2% revenue growth for the pharmaceutical sector in Q4 FY26, with EBITDA and PAT forecasted to decrease. Top picks include Sun Pharma, Aurobindo, Alkem, Gland, and Torrent, which could benefit from a domestic focus. Lupin shows signs of resilience.

Alkem announces the launch of semaglutide injections for diabetes and weight management in India, priced at approximately $25 per month. The company has also revised its fair value to ₹5,911.29 and declared an interim dividend of ₹43 per share for FY26. Additionally, GMP certificates have been obtained for their facilities in Daman and Baddi.

Alkem Labs has increased its investment in a new formulations plant in Ujjain to ₹1036 crore, almost doubling the original ₹533 crore allocation. The expansion of the facility will be carried out in phases.

Alkem Laboratories increases its investment for a new Ujjain plant in Madhya Pradesh from ₹533 crore to ₹1,036 crore, signaling an expansion of operations and commitment to the region's pharmaceutical industry. The investment will be phased over time.

Alkem Labs increases investment in their Ujjain unit to 1,036 crores INR for the expansion of a greenfield facility, marking a doubling of initial funds from 533 crores.

Indian pharmaceutical company Alkem Laboratories has established a new wholly-owned subsidiary named Alkem Pharmaceuticals Scientific Office FZ LLC in Dubai Healthcare City, UAE, for manufacturing products and securing registrations with an initial investment of AED 3.7M.