About API

API Vietnam Company is one of Vietnam’s fastest-growing and pioneering firms, specializing in the import, distribution, and trading of Active Pharmaceutical Ingredients (APIs), Finished Dosage Form (FDFs), excipients, and fine chemical items (including food/feed ingredients and cosmetics).

Two Decades of Excellence: Built on a foundation of over 30 years of leadership insight in API and FDF sectors, and backed by nearly 20 years of sustainable growth, we are proud to be a leading strategic partner in Vietnam’s pharmaceutical industry.

Professional Team: Our experienced and robust team maintains strong client relationships with both international partners and domestic enterprises.

Premium Sourcing: We proudly represent reputable, high-quality foreign manufacturers, offering a diverse portfolio of over 1000 products. This includes specialized antibiotics (Cephalosporin, Penem, Penicillin) sourced from Europe, China, India, and more.

Guaranteed Compliance: All products adhere to the latest international standards and are backed by full GMP/DMF/CEP…. certifications from industry leaders such as Zhejiang, Hunan, ACS Dobfar, Moehs, Cambrex, Supriya, BDR, Welding…..

Global business & sourcing

“Need high-quality APIs /FDFs  and seeking reliable suppliers globally?

We specialize in strategic sourcing to build your cost-effective and regulation-proof pharmaceutical supply chain.

Our professionalism and experience ensure a robust, cost-effective supply chain, connecting quality manufacturers/suppliers with potential customers, with markets worldwide.

We focus on regulatory adherence, risk mitigation, and diverse portfolio expansion, driving global health solutions with integrity and efficiency.”

Technical Transfer

Technical Transfer is the systematic process of moving drug manufacturing knowledge (API formulas, FDF processes, and analytical methods) from one site (Giver) to another (Receiver).

Our comprehensive Technical Transfer service ensures that your product is manufactured with identical quality, safety, and efficacy standards at any chosen global location. We bridge the gap between innovation and reliable commercial supply. It’s the critical step for high-quality global drug supply.

Why Choose Our TT Service?

“Stop Delays, Start Producing.” We utilize a standardized, proven TT methodology, minimizing unexpected quality excursions and regulatory setbacks. This fast-tracks your product from development to commercial availability.

Focus on Core Business: Let our experts manage the complex transfer logistics, allowing your R&D and internal teams to focus on pipeline development and innovation.

“Quality Built-In, Not Checked-On.” Our TT protocols are designed around global regulatory guidelines. We ensure all documentation (Protocols, Reports, Batch Records) adheres to the highest ALCOA data integrity principles.

Risk-Based Approach: We conduct thorough gap analyses and risk assessments early on, preemptively addressing process differences, equipment variations, and facility requirements. This significantly reduces the likelihood of costly manufacturing failures.

“Predictable Costs, Reliable Supply.” A well-executed TT process results in stable manufacturing yields and reduced waste at the Receiver Site. This predictability allows for accurate forecasting and lower overall cost-of-goods (CoGs).

Global Footprint Activation: Successfully leverage new global manufacturing sites for strategic sourcing, accessing new markets, and optimizing your supply chain flexibility.

Core Purpose & Objectives

Objective

Description

Product Equivalence

To verify that the product manufactured at the Receiver Site is functionally and structurally equivalent to the product at the Giver Site.

Regulatory Compliance

To ensure all transferred processes and methods meet strict cGMP (current Good Manufacturing Practice) standards and satisfy all international regulatory requirements (e.g., FDA, EMA).

Risk Mitigation

To identify and eliminate potential operational and quality risks associated with moving the process to a new environment, ensuring a seamless startup.

Scalability & Efficiency

To optimize the process for large-scale, cost-effective commercial production at the new site while maintaining batch consistency.