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viwit Quality Month: Embedding Standards into Everyday Practice, Making Quality Second Nature
Author：
VIWIT
Release Time：
2026-09-30
Every September, China observes its annual Quality Month—a time dedicated to quality, responsibility, and the protection of life. At viwit, however, quality is not an initiative that begins only when Quality Month arrives. It is a commitment we have upheld, day after day, for more than a decade.
Today, through three of our core product categories with regulatory filings and approvals in both China and the United States, we take a closer look at viwit’s longstanding commitment to uncompromising quality.
VivaHearts® Nitroglycerin Sublingual Tablets: Precision Across Every Dose
When an angina attack occurs, every second counts. The accuracy of each dose and the speed of onset can directly affect the effectiveness of emergency treatment.
VivaHearts® Nitroglycerin Sublingual Tablets are the first nitroglycerin sublingual tablet product from a Chinese company to be filed and approved in both China and the United States. The product features a first-of-its-kind stepped-dose portfolio comprising 0.3 mg, 0.4 mg, and 0.6 mg strengths, with the 0.3 mg and 0.4 mg strengths exclusively available in China, addressing an unmet need for more precise dosing options in the domestic market.
To address the inherent volatility of nitroglycerin, which may lead to potency loss and dose variability, viwit independently developed a proprietary stabilizing system. This technology maintains drug content within 100% ± 5% throughout the product shelf life, while controlling disintegration time to within 30 seconds and maintaining a stable therapeutic effect for up to 25 minutes.
A rescue medication may weigh only a few milligrams, yet what it carries can mean everything to a patient and their family.
This is what precision means at viwit.
VivaQuit® Varenicline Tartrate Tablets: Safeguarding Quality Through Rigorous Impurity Control
The challenge of quitting smoking lies in nicotine dependence. The challenge of developing smoking-cessation therapies lies, in part, in the rigorous control of impurities.
VivaQuit® Varenicline Tartrate Tablets were independently developed by viwit over a five-year period and have supported more than 500,000 smokers in their efforts to quit smoking.
One of the most significant technical challenges during development was the control of nitrosamine impurities, an issue that has presented substantial challenges to pharmaceutical manufacturers worldwide. Leveraging proprietary impurity-control technologies backed by independent intellectual property, viwit has maintained nitrosamine impurity levels within internationally established regulatory limits.
Behind every small tablet are countless rounds of analytical method validation, data comparison, and iterative optimization of manufacturing process parameters.
People who choose to quit smoking are making a choice for a healthier life. viwit’s responsibility is to ensure that the medicine supporting that choice is backed by uncompromising quality.
adolinium-Based Contrast Agents: Building a Stronger Safety Foundation Through Molecular Stability
The quality of a contrast agent directly affects not only the accuracy of diagnostic imaging, but also patient safety following administration.
viwit’s two core gadolinium-based contrast agents (GBCAs)—Gadobutrol Injection and Gadoterate Meglumine Injection—both employ macrocyclic stabilization technologies based on DOTA chemistry. Compared with linear structures, macrocyclic structures have a lower propensity to release gadolinium ions, helping reduce the risk of gadolinium deposition in the brain.
Supporting this safety profile is viwit’s vertically integrated quality system, which provides end-to-end control across the entire manufacturing chain—from active pharmaceutical ingredients (APIs) and excipients to finished drug products.
viwit’s API and finished-dosage-form manufacturing sites have successfully passed China GMP compliance inspections. These manufacturing sites have also undergone multiple U.S. FDA cGMP inspections, with inspection outcomes classified as No Action Indicated (NAI) or Voluntary Action Indicated (VAI).
This August, viwit completed the first commercial shipment of Gadobutrol Injection to the United States, marking the first time a contrast agent from China entered the U.S. commercial supply chain.
A vial that crosses the ocean carries more than the product itself. It carries the commitment of China’s pharmaceutical industry to quality on the global stage.
One Commitment to Quality, Across Every Product
