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hydromorphone

Capsules 1.3 mg, 2.6 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Switzerland
GMP approvals
EU GMP, Switzerland
Manufacturer #303

A pharmaceutical manufacturer focused on developing and producing a range of sterile injectable pharmaceutical products, including therapeutic infusions and parenteral formulations for hospital and clinical use. The company operates GMP-compliant facilities and emphasises controlled manufacturing processes, quality assurance and regulatory alignment to ensure the safety, consistency and reliability of its pharmaceutical products.

Manufacturer usually replies in 12 days

Differentiated dosage form

hydromorphone

Tablets, prolonged release (PR) 4 mg, 8 mg, 16 mg, 32 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Switzerland
GMP approvals
EU GMP, Switzerland
Comments
Reference product: Palladone PR, Mundipharma, Junista Janssen-Cilag/Develco
Manufacturer #303

A pharmaceutical manufacturer focused on developing and producing a range of sterile injectable pharmaceutical products, including therapeutic infusions and parenteral formulations for hospital and clinical use. The company operates GMP-compliant facilities and emphasises controlled manufacturing processes, quality assurance and regulatory alignment to ensure the safety, consistency and reliability of its pharmaceutical products.

Manufacturer usually replies in 12 days

hydromorphone

Injection 2 mg/1 ml, 10 mg/ml - 1 ml, 10 ml, 20 mg/1 ml, 50 mg/1 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Austria , Bulgaria , Czech Republic , France , Germany , Hungary , Italy , Latvia , Lithuania , Mexico , Poland , Romania , Slovakia , Sweden , United Kingdom
Comments
Indication: Severe pain
Manufacturer #8070
A pharmaceutical manufacturer that develops, produces and markets both branded medicines and generics, with a focus on treatments for serious and chronic diseases. The company emphasises partnerships, licensing opportunities and specialist indication areas, supporting the global supply of pharmaceutical products via its research & development and manufacturing capabilities.

Manufacturer usually replies in 28 days

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