Laurus Labs API Facility Inspection Concluded with 1 USFDA Observation

Laurus Labs received an update on its Active Pharmaceutical Ingredient (API) manufacturing facility, Unit-4. The US Food and Drug Administration (USFDA) conducted an inspection of the facility located in Andhra Pradesh from January 27 to 31, 2025. The inspection concluded with the issuance of a Form 483 with only 1 observation.

The company has confirmed that it will address the observation within the stipulated timelines. While details of the specific observation have not been disclosed, such regulatory feedback is a routine part of pharmaceutical compliance and does not necessarily indicate critical concerns.

Share price of Laurus Labs made an intraday high of ₹588.30 on NSE. At 12:54 PM, the stock price was trading down by 0.91%. 

Trump Administration’s Funding Halt and Market Reaction

On January 24, the Trump administration paused the disbursement of funds to programmes treating HIV in developing countries for at least 90 days. This move was in line with the ‘America First’ policy, which prioritises domestic interests in policymaking. The decision impacted the US President’s Emergency Plan for AIDS Relief (PEPFAR), a programme that has been instrumental in combating HIV globally.

Following the announcement, shares of Laurus Labs tumbled nearly 14%, influenced by profit-booking after its December quarter earnings report. In response, the company released a statement clarifying that it “reasonably believes” there will not be a significant impact on its business.

Temporary Waiver Restores Funding for Critical HIV Programmes

Amid growing concerns over the funding halt, US Secretary of State Marco Rubio issued a temporary waiver on January 28. This waiver allowed for the continuation of “life-saving humanitarian assistance”, including the PEPFAR programme, but excluded services related to abortion, gender diversity, transgender initiatives, and non-essential healthcare services.

The White House officially announced the waiver on 29th January, a move that was widely welcomed by global health agencies.

UNAIDS and Global Health Community Applaud the Waiver

Following the waiver announcement, UNAIDS Executive Director Winnie Byanyima expressed relief, stating:

“UNAIDS welcomes this waiver from the US Government, which ensures that millions of people living with HIV can continue to receive life-saving HIV medication during the assessment of US foreign development assistance.”

PEPFAR, established during the George W. Bush administration, has played a pivotal role in the fight against HIV/AIDS. Over the years, it has been credited with saving millions of lives, disbursing billions in funding, and providing antiretroviral (ARV) treatment to over 20 million people across 55 countries.

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