Shares of Wanbury Ltd. are trading flat after hitting a day’s high of Rs 234.99 on 9th September. This follows the company’s announcement of receiving a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) for its API (Active Pharmaceutical Ingredient), Dextromethorphan, as reported in a filing with the stock exchanges on Monday.

This API is commonly used as a cough suppressant. The global formulation market for the API was valued at USD 2500 million for FY24, a 7% growth over the previous year. This highlights the growing demand for such cough suppressants worldwide.

With the CEP from the EDQM, the firm can now begin commercial sales of Dextromethorphan in the European region. On 23rd August, the company received an Establishment Inspection Report (EIR) from the USFDA for its Patalganga, Maharashtra facility, with a No Action Indicated (NAI) classification.

This facility, which complies with Current Good Manufacturing Practice (CGMP) standards, enhances Wanbury’s ability to export products into the US and other regulated markets.

The USFDA cleared the Patalganga site on 14th June 2024, with no 483 observations. Upgrades and renovations during part of the quarter affected its capacity, impacting revenues and profits.

The company’s market capitalisation stands at Rs 748 crore. At 2:28 PM, the shares of Wanbury were trading 0.76% lower at Rs 228.55 on NSE.

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