Precision Passed—SMS Lifesciences Hits USFDA Bullseye for Export Boost

Image Source: Pharma Walks

SMS Lifesciences India Ltd. announced the receipt of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), accompanied by a Voluntary Action Indicated (VAI) classification. This regulatory milestone enables the company to expand its exports to the United States and other regulated global markets, reinforcing its position as a trusted manufacturer of Active Pharmaceutical Ingredients (APIs).

What the EIR & VAI Status Mean

The EIR confirms that the USFDA has completed its inspection of SMS Lifesciences’ facility and found it compliant with regulatory standards.
The VAI status indicates that while minor issues were observed, no further regulatory action is required—allowing the company to continue operations and exports.
This approval is critical for SMS Lifesciences’ contract manufacturing and CRAMS (Contract Research and Manufacturing Services) business, especially for U.S.-based clients.

Strategic Impact

The company can now resume or initiate exports of APIs and intermediates to the U.S., a key market for its growth.
The EIR also opens doors to other regulated markets, including Europe and Canada, where USFDA compliance is a benchmark.
SMS Lifesciences is expected to see revenue acceleration in the coming quarters, driven by increased global demand and regulatory credibility.

Company Commentary

“This EIR is a testament to our commitment to quality and global standards. It strengthens our ability to serve regulated markets and expand our international footprint,” said a company spokesperson.

Sources: SMS Lifesciences, Screener, ZaubaCorp, Trendlyne, Bloomberg