The US-Canadian company focuses on drugs for expectant mothers.
Diclegis (doxylamine succinate and pyridoxine hydrochloride) tablets, for the treatment of nausea and vomiting in pregnant women, was also confirmed as gluten, lactose and tartrazine free, making it suitable for patients with coeliac disease and gluten and lactose intolerance.
Manufacturing changes
The independent organisations Kashruth Council of Canada (COR) Kosher Certification Agency and Islamic Society of North America (ISNA) Halal Certification Agency assessed the drug’s manufacturing methods and ingredients to determine their suitability for religious patients.
Duchesnay’s VP, Corporate Affairs, told us the company manufactures Diclegis in-house at a plant in Blainville, Quebec, Canada in line with Kosher and Halal guidelines. It took the company two years to adapt its process.
“Our production team uses only certified ingredients in the making of Diclegis,” said Carole Boyer.
“The cleaning procedures of all the manufacturing material were also approved by the certification agencies. The Passover certification implies that no wheat, oats, rye, barley or spelt are used in the process which makes it suitable also for coeliac patients.”
Re-certification by both agencies will take place each year.
Boyer said the move to certify Diclegis came following customer demand:
“We received over the years many calls from the Jewish and Muslim community inquiring about the presence of specific ingredients in Diclegis. At the time, our product was not suitable for them.”
The global halal pharmaceuticals market was worth up to $34bn in 2014, according to certification expert Farhan Tufail in an interview with in-Pharmatechnologist.com.
While the population of Muslims in Europe is smaller than in Asia, Africa, and the Middle East, European purchasing power makes Turkey, Russia, and France top markets for halal pharma, he said.