Yichang Tianrui Biopharm Co., Ltd., a premier specialty API manufacturer under the Humanwell Healthcare Group, proudly announces a significant regulatory advancement for its high-quality Granisetron API (CAS No.: 109889-09-0). The company has successfully completed the filing with the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), obtaining the crucial "I" status. This designation marks a pivotal step in the registration process, indicating that the technical dossier is formally accepted and under review, with Good Manufacturing Practice (GMP) inspection and certification to follow imminently. This achievement underscores Yichang Tianrui's unwavering commitment to regulatory excellence and positions the company as a rapidly emerging, reliable global supplier of this critical antiemetic agent.

Granisetron: A Trusted Choice in Antiemetic Therapy

Granisetron, a potent and selective 5-HT₃ receptor antagonist, remains a cornerstone in the prevention and treatment of nausea and vomiting induced by chemotherapy, radiotherapy, and postoperative recovery. Its clinical advantages are well-established:

High Efficacy & Selectivity: Offers potent blockade of serotonin receptors in the gastrointestinal tract and central nervous system, providing rapid and effective control of emetic episodes.

Flexible Administration: Available in multiple formulations (IV injection, oral tablets, transdermal patches), allowing for tailored patient care across clinical settings.

Favorable Safety Profile: Generally well-tolerated with a lower incidence of extrapyramidal side effects compared to some older antiemetics, supporting better patient compliance and comfort.

Essential Medicine: Included in the World Health Organization's Model List of Essential Medicines, highlighting its critical role in modern therapeutic regimens.

Why Source Granisetron API from Yichang Tianrui Biopharm?

Choosing Yichang Tianrui as your strategic partner for Granisetron API ensures access to a product of exceptional quality, backed by robust manufacturing capabilities and a client-centric approach.

1.  Imminent GMP Compliance: The "I" status with CDE is a direct precursor to GMP certification. Our state-of-the-art facility in the Baiyang Bio-industrial Park is designed and operated in full compliance with international cGMP standards, ensuring a seamless and swift path to official GMP approval. Our $277 million, 330-acre campus features dedicated, modern production lines capable of delivering consistent, high-purity Granisetron.

2.  World-Class Infrastructure & Expertise: Leveraging Humanwell Group's global leadership in anesthesia and analgesia, we employ advanced technical platforms including high-pressure hydrogenation, lyophilization, and spray drying. Our Phase I investment of $112 million has established 2 commercial GMP workshops and 9 dedicated production lines, providing a solid foundation for scalable, reliable supply.

3. End-to-End Quality & Control: From stringent raw material selection to sophisticated analytical testing and process validation, we implement a full quality management system. This guarantees that every batch of Granisetron API meets the highest pharmacopeial standards (USP, EP, ChP) and your specific specifications.

4.  Proven Track Record in Complex APIs: Our core business spans complex specialty APIs like Samidorphan L-Malate and Maribavir, demonstrating our proficiency in handling sophisticated synthesis and purification processes. Granisetron production benefits from this same rigorous technical and quality culture.

5.  Strategic CDMO Partner: Beyond standard supply, we offer flexible Custom Development and Manufacturing Organization (CDMO/CMO) services. For Granisetron, this can include custom particle size engineering, polymorph control, or the development of specialized formulations to meet unique drug product needs.

6.  Supply Chain Security & Stability: As a wholly-owned subsidiary of Humanwell—a major listed pharmaceutical group—we offer financial stability and long-term commitment. Our vertically integrated capabilities and substantial manufacturing scale provide unmatched supply security and competitive pricing for our partners.

Invitation for Partnership

Yichang Tianrui Biopharm is now actively engaging with pharmaceutical companies worldwide seeking a dependable, quality-driven, and forward-looking supplier for Granisetron API. Our recent CDE "I" status achievement is a testament to our regulatory diligence and technical capability.

We invite you to partner with us to secure your supply chain with a premium API that is on the fast track to full GMP certification. Let us support your antiemetic drug product development and commercialization with reliability, excellence, and a collaborative spirit.

Contact us today to discuss your Granisetron API requirements, request quality documentation, or explore customized CDMO opportunities.

About Yichang Tianrui Biopharm Co., Ltd.

Established in November 2022 and located in Yichang High-Tech Zone, Hubei, Yichang Tianrui Biopharm specializes in the R&D, production, and sales of specialty APIs, pharmaceutical intermediates, and veterinary APIs. Built on the global expertise of the Humanwell Group, the company is dedicated to becoming a world-class partner for innovative and high-quality pharmaceutical ingredients and services.

Contact: Ivy Zhou

Email: ivyzhou@renfu.com.cn  Telephone/Wechat: +86 15072537837  Whatsapp: + 86 15672498608