Yichang, China – Yichang Tianrui Biopharm Co., Ltd., a high-potency and specialty API manufacturer under the global Humanwell Healthcare Group, is proud to announce a significant advancement for its Landiolol Hydrochloride (CAS: 144481-98-1) API. The company has successfully obtained the "I" (Under Inspection) status for its Landiolol Hydrochloride drug dossier from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).

This "I" designation is a definitive regulatory signal, confirming that the CDE has formally initiated the review and inspection process for the associated Drug Master File (DMF). This milestone is the critical step immediately preceding the on-site Good Manufacturing Practice (GMP) inspection. It unequivocally indicates that Yichang Tianrui Biopharm is on an accelerated pathway to securing full China NMPA GMP certification for its Landiolol Hydrochloride manufacturing facilities. For partners worldwide, this means access to a cGMP-compliant, audit-ready API source is imminent.

Landiolol Hydrochloride: The Ultra-Short-Acting Beta-Blocker for Precision Control
Landiolol Hydrochloride is a highly selective, ultra-short-acting β1-adrenergic receptor blocker revolutionizing the management of perioperative and critical care arrhythmias, particularly tachycardia. Its distinct pharmacological profile offers superior advantages in clinical settings requiring rapid, precise, and reversible heart rate control:

• Ultra-Short Half-Life & Rapid Onset: With an exceptionally short half-life of approximately 3-4 minutes, Landiolol allows for immediate titration and near-instantaneous reversal of effects upon discontinuation. This provides clinicians with unparalleled precision in managing acute tachycardia without the prolonged effects of traditional beta-blockers.
• High Cardioselectivity: Landiolol exhibits one of the highest β1-selectivity profiles among beta-blockers. This minimizes unwanted β2-mediated effects, such as bronchoconstriction and peripheral vasoconstriction, making it a safer option for a broader patient population, including those with mild to moderate respiratory comorbidities.
• Ideal for Critical Care & Surgery: Its rapid titratability makes it the agent of choice for controlling atrial fibrillation, atrial flutter, and sinus tachycardia during surgeries (especially cardiovascular procedures), in intensive care units (ICUs), and for emergency settings. It stabilizes hemodynamics without compromising the ability to quickly adjust therapy.

Strategic Advantages of Partnering with Yichang Tianrui Biopharm for Landiolol HCl API

The "I" status achievement underscores our technical capability and commitment to becoming a leading global supplier. Sourcing Landiolol Hydrochloride API from Yichang Tianrui Biopharm provides a compelling, de-risked supply chain strategy:

1. Proven Regulatory Trajectory: Our advanced position in the NMPA review cycle ensures we are a front-runner for GMP certification. Partnering with us secures early access to a fully compliant Chinese pharmacopoeia (ChP) and international cGMP standard API, facilitating your own regulatory filings and market launches.
2. Purpose-Built, Advanced Manufacturing: Our $112 million Phase I facility, featuring dedicated high-potency API (HPAPI) production lines, is engineered for molecules like Landiolol HCl. Advanced technologies, including our sophisticated high-pressure hydrogenation and lyophilization platforms, ensure rigorous control over the complex synthesis, guaranteeing purity, stability, and consistent batch-to-batch quality.
3. End-to-End Expertise in Critical Care APIs: Leveraging the Humanwell Group's global leadership in anesthesia and analgesia, we possess deep domain expertise in manufacturing APIs for the critical care and perioperative medicine segments. This translates into intrinsic understanding and flawless execution for sensitive molecules like Landiolol.
4. Integrated, Scalable, and Secure Supply: We maintain control over key starting materials and critical process steps. This vertical integration, housed within our expansive 330-acre campus, guarantees security of supply, scalability to meet commercial demand, and resilience against supply chain disruptions.
5. A Trusted CDMO Partner: Beyond standard supply, we offer comprehensive CDMO/CMO services. We can support your specific needs for Landiolol HCl, from process optimization and scale-up to customized packaging and analytical method development, providing a true partnership from development to commercialization.

With the CDE's "I" status secured, Yichang Tianrui Biopharm is positioned as the strategic partner of choice for pharmaceutical companies seeking a reliable, high-quality, and soon-to-be GMP-certified source of Landiolol Hydrochloride API.

We invite global innovators and generic drug developers to initiate discussions with us for long-term supply agreements and collaborative partnerships. Secure your supply of this critical care API with a company built on quality, scale, and regulatory excellence.

About Yichang Tianrui Biopharm Co., Ltd.
A wholly-owned subsidiary of Humanwell Healthcare Group (SSE: 600079), Yichang Tianrui Biopharm, established in 2022, is a premier specialty API and HPAPI manufacturer. Based in the Baiyang Bio-industrial Park, Yichang, the company operates a state-of-the-art, multi-phase manufacturing complex with a total investment of $277 million. It is dedicated to the R&D, production, and global sales of specialty APIs, advanced intermediates, and veterinary APIs, while providing elite CDMO services to the pharmaceutical industry worldwide.

Contact: Ivy Zhou

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