Imexpharm is pleased to share exciting news with our customers, shareholders, and investors regarding the registration of our products in Europe. Recently, Imexpharm Pharmaceutical Joint Stock Company received Marketing Authorization (MA) from the Spanish Medicines and Healthcare Products Agency for its product, Cephalexin 500mg hard capsules, a Cephalosporin antibiotic produced at the high-tech Binh Duong Factory (IMP3). This product is highly effective and safe for treatment. The factory was successfully re-assessed and certified with EU-GMP standards in 2019.
Cephalexin 500mg was officially included in the list of products meeting the criteria specified in Article 7, Clause 1, Point c of Circular 15/2019/TT-BYT by the Department of Drug Administration, Ministry of Health, on their website on October 29, 2020.
After the approval of Imetoxim 1g injectable powder, also a Cephalosporin, this is the second product from Imexpharm that has received European market approval. Imexpharm’s strategy is to register at least one product per EU-GMP-certified production line. Currently, the company has 8 certified EU-GMP production lines.
With products receiving MA in Europe, Imexpharm is positioning itself in the high-end market segment, participating in Group 1 drug tenders and expanding exports. In addition to offering a competitive advantage, this milestone is of great significance to the entire Imexpharm team, as it demonstrates the company’s growing production capacity and its path toward integration, placing Vietnamese medicines on par with those from countries with advanced pharmaceutical industries. This achievement lays the foundation for the future export of high-quality "Made in Vietnam" pharmaceuticals.
At present, the IMP3 factory is operating at full capacity, providing high-quality products with effective treatment results for patients. Additionally, the factory plays a crucial role in helping Imexpharm achieve its production and business goals for 2020 and the 2020-2022 period.