As a global leader in spiramycin API production, Topfond Pharmaceutical (China) has been committed to providing high-quality, compliant and stable spiramycin active pharmaceutical ingredients for international pharmaceutical enterprises for decades. With an annual production capacity of 190 tons and a global market share of over 80%, we are the trusted partner for pharmaceutical manufacturers in Europe, Southeast Asia, the Middle East, North Africa and other regions.
Our spiramycin API is derived from the fermentation and purification of Streptomyces ambofaciens, strictly complying with international quality standards including Chinese Pharmacopoeia (CP), European Pharmacopoeia (EP) and United States Pharmacopeia (USP). The product is a white to off-white powder with stable properties, high purity (potency ≥ 900 μg/mg) and low impurity content, which can effectively guarantee the safety and efficacy of downstream preparations.
To meet the strict requirements of global regulated markets, our spiramycin API has obtained a series of international authoritative certifications, including EU EDQM CEP certificate, EU GMP compliance certification, EU WC (Sales Certificate) and COPP certificate, which supports legal registration and sales in EU, India, Southeast Asia and other regions. We have also completed relevant registration with US FDA, and our production process and quality management system fully meet the cGMP requirements of international pharmaceutical standards.
We offer a full range of product specifications to meet diverse customer needs, including spiramycin base, micronized spiramycin (improving dissolution and bioavailability), and salt derivatives such as spiramycin adipate and spiramycin embonate (with enhanced water solubility for suspension and injection development). With a complete GMP production management system and intelligent production equipment, we ensure the stability of product quality and batch consistency, and can provide customized services according to customer requirements.
With years of export experience, our products are exported to more than 20 countries and regions around the world, and we have long-term and stable cooperative relations with well-known pharmaceutical enterprises globally, including successful cooperation negotiations with Egypt's EVA Pharma. We are committed to providing professional pre-sales consultation, stable supply guarantee and efficient after-sales service, helping customers reduce costs and improve market competitiveness. For more information or cooperation inquiries, please contact us via email: junboapi@163.com.