The manufacturer of the popular drugs “Nimid,” “Fucis,” and “Zolopent” may exit the Ukrainian market
13 May 18:56
The State Service of Ukraine on Medicines and Drug Control has released the results of a meeting of the working group on the evaluation of GMP inspections, which took place on May 8.
This was reported by Pharma Media , according to "Komersant Ukrainian".
According to the publication, following the meeting, the State Service of Ukraine on Medicines and Drug Control recommended not issuing a GMP certificate to Kusum Healthcare; this certificate confirms compliance with international quality standards and is mandatory for foreign pharmaceutical manufacturers operating in Ukraine.
What is known about Kusum Healthcare
Kusum Healthcare is one of the major players in the Ukrainian pharmaceutical market and ranks among the top ten largest drug manufacturers in the country. The company’s Ukrainian subsidiary, Kusum Pharm, operates its own production facilities and has over 60 drugs registered with the Ministry of Health of Ukraine.
Among the company’s best-known drugs are “Nimid,” “Fucis,” “Zolopent,” “Serrata,” and “L-Cet.” The company operates in several medical fields, including cardiology, neurology, gastroenterology, endocrinology, and gynecology.
The Kusum Healthcare Group was founded in India in 1994. Today, it has four manufacturing sites—three in India and one in Ukraine—as well as two research centers. The company employs over 2,000 people and has offices in more than ten countries worldwide, including Kazakhstan, Kenya, Mexico, Moldova, and the Philippines.
The media notes that if the GMP certificate is ultimately denied, the company may lose the ability to supply its products to the Ukrainian market, which could potentially affect the availability of several popular medications for patients.
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What decisions were made regarding other companies
During the same meeting, the working group recommended issuing GMP certificates to five manufacturers. Among them are the Turkish company World Medicine, the Indian companies Mankind Pharma, Natco Pharma, and Theon Life Science Industries, as well as the Pakistani company Lucky Core Industries.
“At the same time, the documents of two other manufacturers—Thailand’s Mega Lifesciences and India’s Premium Serums and Vaccines—were sent back for revision following an inspection,” the publication writes.
What is a GMP certificate
A GMP certificate confirms that production complies with international quality and safety standards. Without it, a company is not authorized to import medicines into Ukraine or manufacture them within the country.
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