[et_pb_section fb_built=”1″ admin_label=”section” _builder_version=”4.16″ global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ admin_label=”row” _builder_version=”4.16″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/www.atabay.com\/wp-content\/uploads\/2025\/10\/haber04.png” title_text=”Do\u011fan Ta\u015fkent” _builder_version=”4.27.4″ _module_preset=”default” box_shadow_style=”preset4″ box_shadow_blur=”5px” box_shadow_spread=”5px” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
Turkey’s pharmaceutical sector has, in recent years, demonstrated its capacity to manufacture in compliance with GMP standards on a global scale through its membership in international platforms such as ICH and PIC\/S. Approximately 90% of the medicines consumed in our country are domestically produced, while the remainder is imported. From the perspective of medicine continuity, this represents a significant achievement. The majority of domestically produced medicines are generics (off-patent medicines), while a small proportion consists of originally licensed products manufactured under license. The raw materials for the entire 90% of domestically produced products \u2014 with the exception of 5\u20136 molecules \u2014 are sourced from abroad.<\/p>\n
Approximately 90% of the medicines consumed in our country are domestically produced, while the remainder is imported. From the perspective of medicine continuity, this represents a significant achievement. The majority of domestically produced medicines are generics, while a small proportion consists of originally licensed products manufactured under license. Only a single biosimilar product (Arven \u2013 Filgrastim) has been developed end-to-end \u2014 from cell bank to commercial product \u2014 and is currently available on the market commercially.<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
To date, no original product has been successfully commercialized in our country. Although numerous projects have received financial support from public institutions such as T\u00dcB\u0130TAK and T\u00dcSEB, they have not progressed to full development. While there are many reasons for this, the most significant can be summarized as follows: the know-how required for scale-up has not been sufficiently developed domestically; the process of obtaining marketing authorization directly from the EMA is highly demanding; and projects backed by long-term government procurement guarantees have failed to connect with merit-based manufacturers capable of collaborative development. The pharmaceutical sector is one of a country’s strategic domains. During the COVID-19 period, we observed how the entirety of industrial and national operations came to a halt as a result of the pandemic.\n<\/p>\n
Dependence on foreign sources for chemical raw materials, and the complexity of the marketing authorization process for biosimilar products, constitute the primary obstacles standing in the way of our country’s independence in the pharmaceutical sector. The Traditional Herbal Medicinal Product (THMP) platform \u2014 developed under the regulatory framework of the Turkish Medicines and Medical Devices Agency (T\u0130TCK), affiliated with the Ministry of Health \u2014 has provided our country with a significant and new opportunity.<\/p>\n
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Herbal treatment methods that appear on the Ministry of Health’s approved list, whose therapeutic efficacy has been established among the population over a period of 30 years \u2014 representing, in a sense, a completed Phase IV study \u2014 will be eligible for commercialization under MEDICINAL PRODUCT status (not to be confused with the food supplement pathway) when developed in accordance with the scientific drug development processes prescribed by the applicable regulation. The requirements of such a process encompass infrastructure necessitating multi-million dollar investments, including: Good Agricultural Practice (GAP) and its verification, Good Storage Practice (GSP) and its verification, Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) and its auditing.\n<\/p>\n
This entire process can be implemented and executed under 100% domestic control within our country. Another critical point is that the majority of the plant species required for this process are native to the Anatolian geography. As the intersection of three distinct plant zones, the Anatolian geography harbors a greater diversity of taxa than the entirety of the European continent.\n<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_testimonial _builder_version=”4.27.6″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
[\/et_pb_testimonial][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” global_colors_info=”{}”]It is at this juncture that Atabay stepped in to enable the commercialization of the project initiated by T\u00dcB\u0130TAK (under the Ministry of Industry and Technology) and T\u0130TCK (under the Ministry of Health), and following an extensive period of R&D and ecosystem-building efforts, successfully brought the project to market. When given its due recognition, the product has demonstrated that through public-private collaboration, strategic initiatives can be realized at the national level \u2014 and that by establishing new platforms, new operational models and new markets can be developed.[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_testimonial _builder_version=”4.27.6″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
[\/et_pb_testimonial][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
A Public-Private Collaboration Project<\/p>\n
In March 2017, in collaboration with T\u00dcB\u0130TAK MAM and T\u0130TCK, the project titled “T\u00dcB\u0130TAK 1009 \u2013 Bringing Traditional Herbal Medicinal Products of Anatolian Culture into the Service of Modern Medicine, and Production of Standardized Ruscus aculeatus L. Root and Rhizome Extract” was launched. Plants were collected under supervision in Antalya; their active parts were separated, cleaned, and their conformity was determined through analytical studies.<\/p>\n
Following this, within the scope of the project, a pilot Standardized Extraction facility was established at the T\u00dcB\u0130TAK MAM campus and received GMP approval from the Ministry of Health. Upon completion of the R&D for the production of Ruscus aculeatus<\/em> L. root and rhizome extract, reproducible manufacturing processes (in-process control) were developed. Once the targeted yield, quality, and purity levels were achieved, the process was locked and scale-up phases commenced, culminating in the preparation of a Drug Master File (DMF) document ready for commercial submission. The project was carried out by T\u0130TCK President of the period Hakk\u0131 G\u00fcrsoy, THMP Manager Handan \u00d6ztunca, T\u00dcB\u0130TAK MAM President \u0130brahim K\u0131l\u0131\u00e7aslan, Project Leader Murat Bardak\u00e7\u0131, pharmacognosy luminary Prof. Dr. \u0130rem \u00c7ankaya, Senior Expert Researcher Ceyda \u015eener \u2014 responsible for GMP facility establishment and standardized extraction \u2014 and Senior Expert Dr. Burak D\u00fcr\u00fcs.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n In September 2019, T\u00dcB\u0130TAK MAM invited pharmaceutical companies to a workshop for the project titled ‘T\u00dcB\u0130TAK 1009 \u2014 Bringing Traditional Herbal Medicinal Products of Anatolian Culture to the Service of Modern Medicine and the Production of Standardized Ruscus aculeatus L. Root and Rhizome Extract’<\/em>, with the aim of encouraging the industry to take ownership of the project and support its commercialization.<\/p>\n We were the sole representative from the sector to express interest in the project. There are three primary reasons why this project was of significance to Atabay:<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]In October 2019, we signed our agreements with T\u00dcB\u0130TAK MAM for 100% domestic ‘from seed to shelf’ herbal medicine production. In 2020, as ATABAY, we completed the formulation and analytical studies using the API received from MAM, manufactured the finished medicinal product, initiated stability studies, and prepared the marketing authorization dossier. The marketing authorization application was submitted on 25 December 2020. Technology transfer activities for the Ruscus aculeatus L. root and rhizome extract API from T\u00dcB\u0130TAK MAM to Atabay commenced in September 2021 and continued with the technology transfer of Hedera Helix. Technology transfer and pilot production activities were carried out within MAM. In addition, an emerging start-up operating in this field was supported and successfully integrated into the sector. Throughout this process, collaboration was established with TAGEM (the Agricultural Research and Development Center \u2014 Turkey’s first research institution, founded in 1926 for wheat breeding), and support was provided to facilitate the establishment of a Technology Transfer Office (TTO) interface structure \u2014 similar to those found in universities \u2014 to enable industry collaboration. In July 2024, the marketing authorization was granted by T\u0130TCK, and the commercial product was launched under the name “Neoven 225 mg Capsule”.[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n After a seven-year process, for the first time in our country, 100% domestic ‘from seed to shelf’ herbal medicine production has been achieved. While this may not represent an exceptional breakthrough in terms of the product itself, it is revolutionary in terms of serving as a model for sustained public-private collaboration and in offering a new drug development platform. As ATABAY, we continue our investments in preserving the rich plant biodiversity of Anatolia \u2014 one of Turkey’s natural heritage assets \u2014 and in bringing traditional herbal medicinal products to the service of modern medicine, as well as our efforts toward establishing a sustainable infrastructure for 100% domestic ‘from seed to shelf’ herbal medicine production.<\/p>\n Fikir Liderleri Ekim 2024 (Thought Leaders \u2014 October 2024)<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" A Groundbreaking Achievement from Atabay: 100% Domestic ‘From Seed to Shelf’ Herbal Medicine Production! The pharmaceutical sector is one of a country’s strategic domains. Approximately 90% of the medicines consumed in our country are domestically produced, while the remainder is imported. From the perspective of medicine continuity, this represents a significant achievement. The majority of domestically produced medicines are generics, while a small proportion consists of originally licensed products manufactured under license. Turkey’s pharmaceutical sector has, in recent years, demonstrated its capacity to manufacture in compliance with GMP standards on a global scale through its membership in international platforms such as ICH and PIC\/S. Approximately 90% of the medicines consumed in our country are domestically produced, while the remainder is imported. From the perspective of medicine continuity, this represents a significant achievement. The majority of domestically produced medicines are generics (off-patent medicines), while a small proportion consists of originally licensed products manufactured under license. The raw materials for the entire 90% of domestically produced products \u2014 with the exception of 5\u20136 molecules \u2014 are sourced from abroad. Approximately 90% of the medicines consumed in our country are domestically produced, while the remainder is imported. From the perspective of medicine continuity, […]<\/p>\n","protected":false},"author":4,"featured_media":20655,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[32,293],"tags":[],"class_list":["post-20925","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-featured","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/posts\/20925","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/comments?post=20925"}],"version-history":[{"count":4,"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/posts\/20925\/revisions"}],"predecessor-version":[{"id":20954,"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/posts\/20925\/revisions\/20954"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/media\/20655"}],"wp:attachment":[{"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/media?parent=20925"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/categories?post=20925"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.atabay.com\/en\/wp-json\/wp\/v2\/tags?post=20925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n