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ELELYSO—the first prescription medication to receive kosher certification by the Orthodox Union (OU)

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ELELYSO—the first prescription medication to receive kosher certification by the Orthodox Union (OU)

ELELYSO® (taliglucerase alfa) for injection is certified kosher by the OU. For ELELYSO, kosher certification means that the ingredients and processes used to make the medicine adhere to the kosher laws and traditions that have their origin in the Bible. 

This certification does not change the way ELELYSO is made or what goes into it. While kosher certification is not necessary for lifesaving treatments, or those medications that are not administered orally, it shows Pfizer’s commitment to the Gaucher disease community.

People of Ashkenazi Jewish heritage are affected by Gaucher disease at rates of 1 in 600. In the general population, the condition affects roughly 1 in 50,000 to 1 in 100,000 people.

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Why did Pfizer choose the OU to certify ELELYSO kosher?

The OU is a not-for-profit organization headquartered in New York City that serves the Jewish community on multiple levels. The OU Kosher division is the largest and most well-known kosher certification agency in the world. Although injectable medicines do not require kosher certification, the OU agreed to grant kosher certification to show support for Pfizer’s commitment to the Jewish community afflicted with Type 1 Gaucher disease.

Products the OU certifies kosher—and the facilities making them—are rigorously monitored, regularly inspected, and held to high-quality standards. The organization’s mark on kosher-certified products signifies the products’ rigorous inspection and adherence to those high-quality standards. The OU certifies close to 1 million products in more than 80 countries around the world.

What were the steps involved in kosher certification?

Kosher certification from the OU is a multistep process.

First, Pfizer contacted the OU to apply for kosher certification. Then, the ingredients and manufacturing facility were subject to a rigorous inspection. This included an analysis of the raw materials and the processes used to manufacture ELELYSO. The OU then certified the kosher status of the medication.

The OU will annually reinspect the manufacturing and ingredients of ELELYSO to ensure they remain kosher.

Kosher certification does not involve blessings or other religious rites.

Does the OU kosher certification apply in other countries?

The kosher certification by the OU is global.

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