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Inovexa: one of the pioneers in pharma R&D in Bulgaria

Author Inovexa
Inovexa: one of the pioneers in pharma R&D in Bulgaria

Inovexa is a Bulgarian product and analytical development laboratory specialised in generic dossier development of finished pharmaceutical forms for oral use. Operational since May 2020, Inovexa is the first independent private Bulgarian pharmaceutical company solely focusing on generic R&D as a core activity. Tsvetan Popov has 20 years of experience in generic multinational companies and is a managing director at Inovexa.

Mr. Popov, can you tell us a bit more about Inovexa’s core operations and the services you provide?

Based in Sofia, Inovexa’s development centre has experimental and analytical laboratories which are fully equipped to perform lab-scale prototype and method development for tablets, capsules and granules. Both the premises and the equipment are brand new and designed as per the most current pharmaceutical standards. Inovexa has capabilities and technologies to develop mini and micro tablets, pellets, bi/tri-layer tablets, tablets in capsules, capsules in capsules, all types of functional and cosmetic coatings, mono and combination products. In the analytical lab, we perform method development and validation using the latest analytical technologies, incl. equipment validation and diagnostics.

Since our development centre went live two years ago, Inovexa has already developed four products in a partnership with Antibiotic Razgrad, who manufacture the products and sell them under their own label in Bulgaria. Two of the products already have been launched in Bulgaria and two others are pending regulatory approvals. In 2022, the partners expect to finalise five new development projects followed by six others, which are at different stages of development. In addition, Inovexa has signed contracts and has on-going negotiations for contract- and co-development projects with leading European generic houses. The company is working on several complex generic product developments for modified release formulations and products with no or limited generic competition.

So, Inovexa is in fact active on other markets as well?

Our dossiers are developed in eCTD format, which means they are suitable for filing in Europe and many other countries which recognise EU standards, including from regions such as Eastern Europe, the Middle East and North Africa and Asia. Outside Bulgaria, the products are commercialised through licensing B2B partnerships with generic companies who have a strong commercial presence in those countries. This is a common model in the industry and allows us to grow the size of Bulgaria as an exporter of intellectual property on the pharmaceutical industry map.

Tell us a bit more about your team.

Currently, Inovexa employs eighteen industry experts in the fields of pharmaceutical technology and formulation development, analytical method development, pharmaceutical operations and business development. The team brings an extensive knowledge and expertise gained in international pharmaceutical operations environment.

Being among the pioneers in the pharma R&D field in Bulgaria, one of the key objectives of Inovexa is to continuously develop and grow a knowledge and talent pool focused on research and science. The company provides internship and junior development programmes to high-performing university graduates. Following our belief to invest in people development, diversity and sharing of expertise, the company currently has two interns and one expat position. Going forward, we plan to continue attracting foreign expertise and young talent.

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