Views: 0 Author: Site Editor Publish Time: 2025-09-12 Origin: Site
The recent news that a Chinese pharmaceutical manufacturer has obtained a CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) for its Telmisartan Process II active pharmaceutical ingredient (API) marks an important milestone for both the company and the broader global supply chain. This certification not only demonstrates that the API fully complies with the stringent requirements of the European Pharmacopoeia, but also affirms the high-quality manufacturing standards recognized by European regulatory authorities.
For api manufacturers and pharmaceutical raw material suppliers, such an achievement represents more than compliance—it signals opportunity. With a CEP in hand, the Telmisartan API can now be marketed freely within the European Union and in numerous other international markets that acknowledge CEP certificates, significantly broadening the product’s reach.
Telmisartan is a well-established angiotensin II receptor blocker (ARB), widely used in the treatment of hypertension and cardiovascular diseases. By selectively blocking the angiotensin II type 1 receptor, it reduces vasoconstriction and aldosterone activity, ultimately lowering blood pressure and reducing cardiovascular risk.
The demand for Telmisartan has steadily increased as hypertension and related disorders remain prevalent worldwide. For this reason, ensuring cost-effective, sustainable, and high-quality production of Telmisartan APIs has become a priority for global pharmaceutical supply chains.
The traditional synthesis of Telmisartan involved multiple coupling steps, such as benzimidazole ring formation combined with the introduction of dicarboxylic acid derivatives. While effective, this Process I approach was associated with several significant drawbacks:
Complex reaction sequence: multiple protection and deprotection steps increased time and labor.
Lower yields: inefficiencies in key coupling reactions led to reduced overall yield.
Higher costs: longer steps, expensive reagents, and higher energy consumption contributed to production cost challenges.
By-products and impurities: multiple-step synthesis led to the generation of undesired side products, complicating purification.
The Process II route of Telmisartan represents a major improvement in terms of green chemistry, scalability, and cost efficiency:
Process optimization: By modifying the synthesis of key intermediates, the reaction pathway is shortened, minimizing protection/deprotection cycles.
Green chemistry compliance: Greater use of halogen-free solvents and environmentally friendly reagents makes the process consistent with ICH and EMA sustainability guidelines.
Higher yield and purity: Adoption of advanced coupling agents or even continuous flow chemistry enhances efficiency and reduces impurities.
Crystallization improvements: Optimized crystallization techniques yield stable polymorphs of Telmisartan (such as Form A and Form B), which ensures better compatibility with formulation development.
These improvements not only reduce production costs but also align the API manufacturing process with modern regulatory expectations on sustainability and safety.
Achieving CEP certification for Telmisartan Process II brings several key advantages:
Market Access: CEP is recognized across Europe and in multiple international jurisdictions, enabling the manufacturer to supply Telmisartan API in regulated markets without undergoing additional local pharmacopoeial testing.
Regulatory Confidence: Demonstrates full compliance with European Pharmacopoeia standards, ensuring global partners of consistent quality and safety.
Commercial Advantage: Enhances competitiveness of the manufacturer in the API market, particularly in Europe where regulatory rigor is high.
Industry Recognition: Validates the company’s R&D and manufacturing capabilities, strengthening its reputation as a reliable API supplier.
For global pharmaceutical raw material suppliers, this development broadens sourcing options and assures access to a sustainable, high-quality Telmisartan API.
The approval reflects not only the manufacturer’s technical expertise but also China’s growing role in the international API supply chain. As European and U.S. markets continue to focus on drug security and diversification of supply sources, Chinese active pharmaceutical ingredient manufacturers that achieve CEP certifications will play an increasingly central role.
Looking forward, the combination of process innovation (such as continuous flow synthesis and crystallization optimization) with regulatory achievements like CEP will likely become the benchmark for competitiveness in the global API market. Moreover, as green chemistry practices gain momentum, Process II’s alignment with sustainability standards positions Telmisartan as a model for modern pharmaceutical manufacturing.
The granting of a CEP certificate for Telmisartan Process II API is more than a regulatory achievement—it is a strategic gateway to global markets. By refining synthesis steps, embracing eco-friendly chemistry, and ensuring higher yield and purity, Process II demonstrates how innovation can transform a widely used cardiovascular drug into a more sustainable and commercially competitive product.
For api manufacturers and pharmaceutical raw material suppliers, this milestone represents a tangible example of how advanced process development, regulatory compliance, and global market alignment can converge to shape the future of the pharmaceutical raw material industry.
