VINPHACO GOT 1ST GMP CERTIFICATE FROM THE FDA PHILIPPINES

Vinh Phuc Pharmaceutical Joint Stock Company (Vinphaco) is one of the most established GMP – WHO manufacturers in Vietnam, with more than 60 years of experience in producing high-quality medicines for both domestic and international markets. Over the decades, Vinphaco has built a strong reputation in sterile injectable manufacturing, along with a diverse portfolio of oral solid and other essential dosage forms. Leveraging WHO-GMP–compliant facilities, modern production technologies, and a well-experienced regulatory team, Vinphaco has continuously expanded its export footprint to multiple countries across Asia, Africa, and other regions. Today, export is a strategic pillar of Vinphaco’s long-term development, with a clear focus on regulated and semi-regulated markets that require strict GMP compliance, robust quality systems, and reliable long-term supply capabilities.

1. The Philippines pharmaceutical market and GMP inspection in the factory of Vinphaco

Among Southeast Asian markets, the Philippines stands out as one of the most promising and fast-growing pharmaceutical markets in the region. With a large population, rising healthcare awareness, expanding health insurance coverage, and increasing government and private investment in healthcare infrastructure, demand for quality medicines in the Philippines continues to grow steadily. At the same time, the Philippine regulatory environment has become increasingly stringent, with the Philippines Food and Drug Administration (Philippines FDA) aligning its regulatory framework and GMP requirements more closely with international standards. This creates both opportunities and challenges for foreign manufacturers: only companies with strong quality management systems, well-controlled manufacturing processes, and complete, transparent documentation can sustainably enter and remain competitive in this market. Recognizing the strategic importance of the Philippines, Vinphaco has proactively invested in strengthening its GMP systems to meet the expectations of this important ASEAN market.

As part of this strategy, Vinphaco recently underwent a comprehensive GMP inspection conducted by the Philippines FDA in June 2025. The inspection was carried out over five consecutive days and covered the full scope of our pharmaceutical operations. During the audit, the inspection team thoroughly evaluated all manufacturing lines, including sterile injectable production, as well as quality control and quality assurance laboratories, utilities, warehouses, and supporting systems. In addition to on-site facility inspections, the auditors conducted an in-depth review of GMP documentation, including standard operating procedures (SOPs), batch manufacturing records, validation and qualification documents, stability programs, laboratory controls, deviation and CAPA systems, and overall quality management processes. The inspection was detailed and rigorous, reflecting the Philippines FDA’s high expectations for manufacturers supplying products to its national healthcare system.

2. Vinphaco was honnored to receive GMP Certification from PFDA

We are proud to announce that, following this intensive regulatory inspection, Vinphaco successfully passed the factory audit and was officially granted the Good Manufacturing Practice Certificate by the Philippines authority for all production lines in lyophilized powder for injection, solution for injection, nebulization solution, oral lines such as tables, capsules, powders as well as health supplements. This result confirms that Vinphaco’s manufacturing facilities, laboratories, and quality systems fully comply with the GMP standards required by the Philippine regulatory authority. The certification is a strong endorsement of our long-standing commitment to pharmaceutical quality, patient safety, and regulatory compliance. It also marks an important milestone in Vinphaco’s international expansion, enabling smoother product registration, faster market entry, and more efficient collaboration with partners in the Philippines. Moving forward, Vinphaco remains committed to continuous improvement and to serving as a reliable, long-term pharmaceutical partner, delivering safe, effective, and high-quality medicines to the Philippines and other international markets worldwide.