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Difelikefalin acetate manufacturers

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difelikefalin acetate

Vials, injection 63 mg/1.3 ml, 50 mg/ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #8822
A pharmaceutical manufacturer based in Europe that has been active in 60+ countries selling its products in Europe, North America, LATAM, MENA, and Asia for 50+ years. The main therapeutic areas include CNS, ophthalmology, and dermatology. Main dosage forms include sterile and solid oral dosage forms. The company's production lines are cGMP-compliant. The company possesses branches in Europe, North America, and Asia.

difelikefalin acetate

Injection 50 mcg/ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
China
Comments
US ANDA Submission (2027)
Manufacturer #29288

This hi-tech enterprise specializes in the research and manufacturing of diverse peptide products. Founded in 1998, it has become one of the leading peptide pharmaceutical companies globally, offering a full range of services including finished dosage products, APIs, and CRO/CMO services. Their finished dosage products are primarily sold domestically, while APIs have international distribution. The company operates a GMP-certified manufacturing facility exceeding 1500 sq. m., regularly inspected by local and international authorities. They focus on several key therapy areas, employing various principal dosage forms, including peptide-based formulations.

difelikefalin acetate

Vials, injection 65 mcg/1.3 ml - 2 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #551
India-based sterile injectables manufacturer and CDMO with multiple decades of operational experience. Rx injectable portfolio spanning several specialty therapy areas is supplied to regulated markets including North America, Europe, and Australia. Facilities hold US FDA, EU-GMP, and PMDA approvals.

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