insulin degludec + insulin aspart Injection 300 IU - 3 ml
Dossier type
US CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
FDA
Unavailable markets
Bahrain
, Kuwait
, Oman
, Qatar
, Saudi Arabia
, United Arab Emirates
, United States
, Kuwait
, Oman
, Qatar
, Saudi Arabia
, United Arab Emirates
, United States
Manufacturer #38346
Manufacturer was incorporated on 27 December 2021 in Surat, Gujarat, India, with about 28 employees. As a CTD dossier owner and manufacturer, it operates a WHO-GMP certified and EU-compliant formulation plant under CGMP norms. Products reach markets in India, Yemen, Zambia, Venezuela, Ghana, Kenya, and Tanzania for international presence. Designed to comply with rigorous “Revised Schedule M” rules from India’s Drug Controller. As a CTD dossier owner and manufacturer, it aims for regulatory readiness in global submissions. Recognized as a GMP manufacturer, it ensures standards of safety, purity, and efficacy in all batches.
Manufacturer usually replies in 11 days
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