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roxatidine

Capsules 75 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
EU GMP, WHO, PICS
Manufacturer #20943

​Established in 1954, this Manufacturer is a CTD dossier owner and manufacturer with a global presence spanning over 15 countries and regions. With a workforce of approximately 1,000 employees, it operates GMP-certified facilities in South Korea, producing tablets, capsules, and injectable formulations. As a GMP manufacturer, it holds certifications such as PIC/S GMP and EU GMP compliance. The Manufacturer's commitment to excellence as a CTD dossier owner and manufacturer and GMP manufacturer solidifies its reputation in the global pharmaceutical market.​

 

Manufacturer usually replies in 11 days

roxatidine

Injection 75 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
EU GMP
Comments
Ref. Altat
Manufacturer #10844
A pharmaceutical manufacturer operating as an end-to-end CDMO/CMO partner for pharmaceutical products, with vertically integrated capabilities spanning active pharmaceutical ingredients, intermediates, and finished oral solid dosage forms such as tablets and capsules. The company highlights multiple cGMP-inspected manufacturing sites supporting both API and formulation supply, alongside strong in-house development and analytical support for scale-up and commercial production. Its quality system is described as fully GMP-driven across operations, with APIs having undergone EU-GMP inspection/certification and oral solid pharmaceutical products produced under Chinese GMP requirements, reinforced by a mature EHS and compliance culture to ensure reliable global supply.

Manufacturer usually replies in 72 days

roxatidine

Capsules 37.5 mg, 75 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
PICS
Manufacturer #18707
It was established in the 1980s. The company has continued to attain strong growth and has sprung into a global biotech company with a continuous trade surplus in the global market. The company manufactures more than 150 pharmaceutical products, and approved products are more than 340 products from MFDS (Ministry of Food and Drug Safety). For the quality intensification and maximizing of productive capacity, the company completely equipped its manufacturing structure and facilities for producing pharmaceutical products guaranteed safety and effectiveness with stability.

Manufacturer usually replies in 56 days

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