A Landmark Achievement in Global Health
Hebei Xingang Pharmaceutical's Rifampicin Achieves WHO Approval
On June 9, 2025, the WHO announced that Hebei Xingang's Rifampicin API meets the highest standards for quality, safety, and manufacturing, marking its official entry into the WHO market to combat tuberculosis globally.
Explore the MilestoneUnderstanding the Core Pillars
This achievement rests on three critical foundations: the WHO's rigorous Prequalification program, universal Good Manufacturing Practices, and the vital role of Rifampicin.
WHO Prequalification
A global benchmark for medicine quality, safety, and efficacy. The WHO-PQ program ensures that essential medicines meet stringent international standards, building trust in global supply chains.
GMP for APIs
The gold standard for pharmaceutical manufacturing. Good Manufacturing Practices ensure that Active Pharmaceutical Ingredients (APIs) are produced consistently and safely, minimizing all risks.
Rifampicin's Role
A cornerstone antibiotic in the global fight against tuberculosis. Quality-assured Rifampicin is critical for effective treatment, preventing drug resistance, and saving lives.
The Path to Prequalification
Achieving WHO-PQ is an exhaustive process that validates every aspect of a product's lifecycle. Click each step to learn more about this rigorous journey.
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Global Impact & Significance
This approval has far-reaching consequences, from strengthening supply chains to improving patient outcomes worldwide.
Context: The Global Fight Against TB
Tuberculosis remains a major global health challenge. The availability of quality-assured medicines like Rifampicin is a critical component of the WHO's strategy to combat priority diseases.
A Threefold Victory for Public Health
Combats Drug Resistance
Ensures effective first-line treatments are available, preventing the rise of deadly drug-resistant TB strains.
Strengthens Supply Chains
Diversifies the pool of prequalified manufacturers, enhancing the resilience and reliability of global medicine supply.
Improves Patient Outcomes
High-quality medicines directly translate to better treatment results and reduced mortality from tuberculosis.
Hebei Xingang Pharmaceutical: A Commitment to Excellence
This achievement is the result of an unwavering dedication to quality at every level of the organization.
Robust Quality Systems
Implementing comprehensive systems that govern every aspect of operations, from raw material sourcing to final product release.
Advanced Facilities
Investing in state-of-the-art manufacturing facilities designed to prevent contamination and ensure optimal, consistent production.
Skilled Workforce
Employing a highly trained and competent team dedicated to upholding the most stringent GMP and international quality standards.
Hebei Xingang Pharmaceutical
WHO-PQ & GMP Approved Rifampicin for Global Health Excellence
Hebei Xingang Pharmaceutical's Rifampicin Achieves WHO-PQ and GMP Approval
A Landmark Achievement in Pharmaceutical Quality
Introduction
In a significant development for global public health, on June 9, 2025, at 3:52 pm, the World Health Organization (WHO) officially announced that Hebei Xingang Pharmaceutical Co Ltd's Rifampicin has successfully met the stringent WHO Prequalification (WHO-PQ) standards and is fully compliant with the principles of Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs). This monumental achievement not only underscores Hebei Xingang Pharmaceutical's unwavering commitment to producing high-quality pharmaceutical products but also marks its official approval to enter the crucial WHO market.
Understanding WHO-PQ Standards
The WHO Prequalification (WHO-PQ) program is a comprehensive United Nations program established to ensure that health products procured by international agencies for developing countries meet acceptable standards of quality, safety, and efficacy. This rigorous assessment process involves a detailed evaluation of product quality, manufacturing site inspections, and laboratory testing. For a pharmaceutical product like Rifampicin to achieve WHO-PQ status, it must demonstrate consistent adherence to international norms, standards, and guidelines throughout its development and production lifecycle.
Adherence to Good Manufacturing Practices (GMP) for APIs
Good Manufacturing Practices (GMP) are a system of quality assurance that ensures products are consistently produced and controlled according to quality standards. For Active Pharmaceutical Ingredients (APIs), GMP compliance is particularly critical as APIs are the biologically active components of a drug product. The stringency of GMP in API manufacturing increases progressively from early synthesis steps to final purification and packaging, reflecting the escalating risk associated with each stage of production.
The Importance of Rifampicin in Global Health
Rifampicin, also known as rifampin, is a cornerstone antibiotic in the fight against several severe bacterial infections, most notably tuberculosis (TB) and certain forms of meningitis. As a potent ansamycin antibiotic, it plays a critical role in multi-drug regimens for TB, a disease that continues to be a major global health challenge. Its efficacy in killing or preventing the growth of various bacteria, including Mycobacterium tuberculosis and Neisseria meningitidis, makes it an indispensable medicine.
Hebei Xingang Pharmaceutical's Commitment to Quality and Innovation
Hebei Xingang Pharmaceutical Co Ltd has consistently demonstrated a profound commitment to quality, innovation, and continuous improvement within the pharmaceutical industry. This recent WHO-PQ and GMP approval for Rifampicin is not an isolated event but rather a reflection of the company's deeply ingrained philosophy of excellence. The company invests significantly in research and development, constantly seeking to enhance its manufacturing processes, optimize product formulations, and explore new therapeutic applications for its active pharmaceutical ingredients.
Future Implications and Market Entry
The official approval of Hebei Xingang Pharmaceutical Co Ltd's Rifampicin for entry into the WHO market signifies a pivotal moment for the company and for global health. This endorsement by the World Health Organization opens doors to new opportunities, allowing Hebei Xingang Pharmaceutical to significantly expand its reach and impact. The WHO-PQ status enables procurement agencies, non-governmental organizations, and national health programs worldwide to confidently source Rifampicin from Hebei Xingang, knowing it meets the highest international quality standards.
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Learn More About Our ProductsConclusion
The official announcement by the World Health Organization on June 9, 2025, at 3:52 pm, confirming Hebei Xingang Pharmaceutical Co Ltd's Rifampicin compliance with WHO-PQ and GMP standards, marks a significant milestone in the pharmaceutical industry. This achievement not only validates the company's unwavering dedication to producing high-quality Active Pharmaceutical Ingredients but also reinforces its crucial role in global health. By ensuring that Rifampicin, a vital antibiotic for treating tuberculosis and preventing meningitis, meets the most rigorous international benchmarks, Hebei Xingang Pharmaceutical is directly contributing to improved public health outcomes worldwide.
