Barekat Health & Pharmaceutical Group: Saman Darou 8 Co., a knowledge-based enterprise under Barekat Holding, has successfully obtained the official marketing authorization for its recombinant coagulation Factor VIII product, “Safacto,” in Sri Lanka.

The certification—issued for both 250 IU and 500 IU dosage forms—is valid for a period of two years and represents formal approval for importation, marketing, and clinical use of Safacto in the Sri Lankan pharmaceutical market.

Safacto: A National Innovation with Global Standards

Safacto, a recombinant Factor VIII therapy indicated for Hemophilia A, is manufactured using advanced biotechnological methods at Saman Darou 8, with full reliance on domestic expertise and innovation.

Having long been approved and distributed within Iran’s healthcare system, this international registration marks a new milestone—recognition of Safacto’s quality, safety, and efficacy in compliance with the rigorous standards set forth by global regulatory authorities, including Sri Lanka’s National Medicines Regulatory Authority (NMRA).

Strategic Advancement in Export Market Development

The formal entry of Safacto into the Sri Lankan market signifies Saman Darou 8 first impactful step in international pharmaceutical export. This achievement is the result of months of coordinated efforts between scientific, regulatory, commercial, and export teams—and it highlights the company’s strong potential to expand into global markets.

Given the demand in regional and emerging markets for high-quality, cost-effective treatments for rare and chronic diseases, this registration paves the way for broader commercial engagement across Asia and beyond.

Synergy within Barekat Pharmaceutical Group

This important milestone was made possible through the strategic vision and active support of the Barekat Health and Pharmaceutical Group. Barekat has consistently championed domestic innovation, export development, and public health advancement, enabling its subsidiaries to grow beyond borders.

A Bright Horizon for Internationalization of Saman Darou

The registration of Safacto in Sri Lanka opens the door for further international submissions across Southeast Asia, Africa, and Latin America. In line with its strategic roadmap, Saman Darou 8 is actively preparing for the registration and export of additional recombinant and biologic products to targeted global markets.

Acknowledgment & Vision Forward

Saman Darou 8 expresses its sincere appreciation to the scientific, commercial, regulatory, and international teams whose dedication made this success possible, as well as to the leadership of the Barekat Holding for their guidance and continued support.

This is not merely an endpoint, but the beginning of a broader mission—to elevate the global presence of Iranian pharmaceutical science and serve patients worldwide.