SUNHERE Secures Two Additional US DMF Filings!
Hydroxypropyl Cellulose & Hypromellose Acetate Succinate Successfully FiledGlobal Qualification Matrix Further Upgraded!
Recently, our core products Hydroxypropyl Cellulose and Hypromellose Acetate Succinate have secured official FDA DMF filings.
This key breakthrough upgrades our global certification portfolio for premium cellulose ether excipients, delivering fully qualified, reliable Chinese excipient options to worldwide drug manufacturers.
Hydroxypropyl Cellulose(HPC)
DMF Filing Number: 043994
Product Application: A non-ionic cellulose ether with excellent adhesion, matrix sustained/controlled release and film-forming coating properties. It is widely used in tablets, capsules, sustained and controlled-release preparations, transdermal patches and other fields, serving as a key excipient for high-end formulation prescriptions.
Market Significance: This additional filing further consolidates the company's technological and certification advantages in cellulose ether excipients, and meets the compliance demands of global customers for high-end binders and sustained/controlled-release materials.
Hypromellose Acetate Succinate
DMF Filing Number: [043995]
Product Application: It is a premium enteric coating material that dissolves at pH 5.5 and above. It enables precise intestinal targeted drug release and significantly improves bioavailability, making it a core coating excipient for high-end generic and innovative drugs.
Market Significance: This filing fills the gap in the company's international certifications in the high-end enteric coating sector. It helps domestic high-end preparations reduce reliance on imported excipients and accelerates the process of domestic substitution.
As a leading domestic manufacturer of pharmaceutical excipients, Sunhere has always driven product quality upgrading in line with international standards and continuously advanced qualification certifications for major global markets.
To date, the company has obtained FDA DMF filing numbers for 17 core products, covering a full range of oral solid dosage excipients including fillers, binders, disintegrants, coating materials, lubricants and more. This has built an industry-leading international qualification moat for the enterprise.
Founded in 2001, Sunhere Pharmaceutical Excipients has specialized in the R&D, production and sales of pharmaceutical excipients for 25 years. It is a leading domestic enterprise of pharmaceutical excipients for oral solid preparations, a national "Specialized, Refined, Characteristic & Innovative" Little Giant Enterprise, and a national key high-tech enterprise.
The company holds 48 CDE registrations, 17 US FDA DMF filings, as well as 11 EU EXCiPACT certifications and CEP certificates. Its products are exported to more than 50 countries and regions worldwide, serving over 3,500 pharmaceutical enterprises, and empowering domestic pharmaceutical preparations to go global.
The successful DMF filings of Hydroxypropyl Cellulose and Hypromellose Acetate Succinate this time once again validate the company's technical strength and quality management system.
Going forward, Sunhere will continue to focus deeply on the high-end pharmaceutical excipient sector. With more comprehensive global qualifications, higher-quality products and services, we will help China's pharmaceutical industry achieve the leap from "Made in China" to "Created in China", and deliver safer and more effective pharmaceutical solutions for patients across the globe.
SUNHERE Secures Two Additional US DMF Filings!
Hydroxypropyl Cellulose & Hypromellose Acetate Succinate Successfully FiledGlobal Qualification Matrix Further Upgraded!
Recently, our core products Hydroxypropyl Cellulose and Hypromellose Acetate Succinate have secured official FDA DMF filings.
This key breakthrough upgrades our global certification portfolio for premium cellulose ether excipients, delivering fully qualified, reliable Chinese excipient options to worldwide drug manufacturers.
Hydroxypropyl Cellulose(HPC)
DMF Filing Number: 043994
Product Application: A non-ionic cellulose ether with excellent adhesion, matrix sustained/controlled release and film-forming coating properties. It is widely used in tablets, capsules, sustained and controlled-release preparations, transdermal patches and other fields, serving as a key excipient for high-end formulation prescriptions.
Market Significance: This additional filing further consolidates the company's technological and certification advantages in cellulose ether excipients, and meets the compliance demands of global customers for high-end binders and sustained/controlled-release materials.
Hypromellose Acetate Succinate
DMF Filing Number: [043995]
Product Application: It is a premium enteric coating material that dissolves at pH 5.5 and above. It enables precise intestinal targeted drug release and significantly improves bioavailability, making it a core coating excipient for high-end generic and innovative drugs.
Market Significance: This filing fills the gap in the company's international certifications in the high-end enteric coating sector. It helps domestic high-end preparations reduce reliance on imported excipients and accelerates the process of domestic substitution.
As a leading domestic manufacturer of pharmaceutical excipients, Sunhere has always driven product quality upgrading in line with international standards and continuously advanced qualification certifications for major global markets.
To date, the company has obtained FDA DMF filing numbers for 17 core products, covering a full range of oral solid dosage excipients including fillers, binders, disintegrants, coating materials, lubricants and more. This has built an industry-leading international qualification moat for the enterprise.
Founded in 2001, Sunhere Pharmaceutical Excipients has specialized in the R&D, production and sales of pharmaceutical excipients for 25 years. It is a leading domestic enterprise of pharmaceutical excipients for oral solid preparations, a national "Specialized, Refined, Characteristic & Innovative" Little Giant Enterprise, and a national key high-tech enterprise.
The company holds 48 CDE registrations, 17 US FDA DMF filings, as well as 11 EU EXCiPACT certifications and CEP certificates. Its products are exported to more than 50 countries and regions worldwide, serving over 3,500 pharmaceutical enterprises, and empowering domestic pharmaceutical preparations to go global.
The successful DMF filings of Hydroxypropyl Cellulose and Hypromellose Acetate Succinate this time once again validate the company's technical strength and quality management system.
Going forward, Sunhere will continue to focus deeply on the high-end pharmaceutical excipient sector. With more comprehensive global qualifications, higher-quality products and services, we will help China's pharmaceutical industry achieve the leap from "Made in China" to "Created in China", and deliver safer and more effective pharmaceutical solutions for patients across the globe.
