Views: 0 Author: Site Editor Publish Time: 2025-05-07 Origin: Site
Shandong Loncom Pharmaceutical Co., Ltd. has achieved a major regulatory milestone by obtaining the Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for its Sorafenib Tosylate active pharmaceutical ingredient (API). This accomplishment highlights the company's dedication to global quality standards and strengthens its position in the competitive oncology drug market.
A Recognition of Pharmaceutical Excellence
The CEP certification confirms that Shandong Loncom’s Sorafenib Tosylate complies with the stringent quality and safety requirements of the European Pharmacopoeia (Ph. Eur.). This endorsement allows the company to supply this critical API to pharmaceutical manufacturers across Europe and other international markets, facilitating broader patient access to life-saving cancer treatments.
The Significance of Sorafenib Tosylate
Sorafenib Tosylate is a tyrosine kinase inhibitor (TKI) used in the treatment of advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and radioactive iodine-resistant thyroid cancer. As a key component in generic versions of the blockbuster drug Nexavar®, this API plays a crucial role in global oncology therapeutics. The CEP approval assures global partners of Shandong Langnuo’s ability to produce high-purity, reliable, and compliant Sorafenib Tosylate.
Enhancing Global Market Access
With this certification, Shandong Loncomreinforces its reputation as a trusted API manufacturer and expands its footprint in the European and international pharmaceutical sectors. The company’s adherence to Good Manufacturing Practices (GMP) and commitment to regulatory excellence position it as a preferred supplier for generic and innovative drug developers.
Future Growth and Commitment to Quality
This achievement aligns with Shandong Loncom’s strategic vision to increase regulatory approvals and foster collaborations with global pharmaceutical companies. The CEP certification not only validates the company’s technical expertise but also supports its mission to deliver affordable, high-quality oncology APIs worldwide.
Congratulations to Shandong Loncom Pharmaceutical on this remarkable accomplishment!
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话题标签#Sorafenib Tosylate 话题标签#API 话题标签#Loncom
