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Exclusive period for rare disease/childhood drugs arrives; tantalum surface alloy technology solves the problems of small batch production and high corrosion

2026-03-10View Original

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The newly revised Regulations for the Implementation of the Drug Administration Law (issued on January 16, 2026, and effective as of May 15) introduce a market exclusivity period for the first time: 2 years or less for new varieties/formulations/indications of drugs intended for children; Drugs for rare diseases (with guaranteed supply) ≤7 years. This policy encourages the research and development of high-value niche drugs; however, challenges related to small batch sizes, multiple solvents, and highly corrosive processes remain prominent. Tantalum surface alloying technology, with its exceptional corrosion resistance and zero pollution advantages, has become the preferred choice for upgrading pharmaceutical equipment. https://p3-sign.toutiaoimg.com/tos-cn-i-axegupay5k/0e707e013c7f4f599f588ee30f417f45~tplv-tt-origin-web:gif.jpeg?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1773713626&x-signature=cTB7Cr4Pm0Y0t%2BBSzrsZwqgxHdM%3D Rare diseases/Key challenges in children’s drug production: small batch sizes and frequent changes in product varieties ; Strong acids (hydrochloric acid, sulfuric acid, aqua regia), organic solvents, high-temperature and high-pressure media ; Zero ion migration, pollution prevention, GMP high standards ; Frequent CIP/SIP verification results in high maintenance costs. Traditional materials are prone to corrosion, ion release, and frequent downtime, hindering scaling up and compliance. Key advantages of tantalum surface alloying technology: Tantalum surface alloys (such as CVD/CVI deposition processes) far surpass 316L/Hastelloy/titanium in terms of performance: extreme corrosion resistance – resistant to all inorganic acids/alkalis/organic solvents, capable of withstanding high temperatures above 250°C, with very low corrosion rates

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