Citi Pharma gets FDA nod to start exporting nutraceuticals to the United States

The pharmaceutical ingredients manufacturer enters the consumer-facing market in the US with a product the US regulator classifies as food, and not drugs

Citi Pharma, the Lahore-based drug manufacturer and the country’s largest producer of active pharmaceutical ingredients (APIs) is set to begin exporting nutraceutical products to the United States after the US Food and Drug Administration (FDA) allowed its products to gain access to that market.

In a notice sent to the Pakistan Stock Exchange on Friday, the company stated that intended to export products in fertility, weight management, stress and mood boosters, hair and skin care, and joint and muscle pain. The company expects to generate $3 million (Rs832 million) in export revenue from these products, and expects profit margins in the 25-30% range, though it did not specify whether those would be gross profit margins or net profit margins.

The revenue number would amount to a 6.4% increase in the company’s revenue, based on the revenue data for the 12 months ending March 31, 2024, the latest period for which financial statements are available.

While the company consistently used the phrase “FDA approval” in its announcement, that phrase has a meaning in this context that is different from what “FDA approval” normally means. Specifically, neutraceuticals are governed under a distinct regulatory category for dietary supplements, treating them as a subset of foods rather than drugs.

 

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