Metreleptin Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 11.3 mg/vial
Reference Brands: Myalept(US & EU)
Category:
Weight Loss drugs
Metreleptin injectable solution replaces leptin, a hormone regulating appetite, metabolism, and insulin sensitivity. It improves metabolic control, reduces hunger, and manages lipodystrophy-related complications. Benefits include decreased insulin resistance, better lipid profiles, enhanced energy, and weight stabilization, supporting overall metabolic health in leptin-deficient patients worldwide.
Metreleptin Injectable Solution is available in Injectable Solution
and strengths such as 11.3 mg/vial.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Metreleptin Injectable Solution is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Metreleptin Injectable Solution can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Metreleptin injectable solution, marketed as Myalept, is approved in the US by the FDA and in the EU via EMA for leptin deficiency associated with lipodystrophy. Regulatory approval requires dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe administration, and global availability, helping patients with leptin deficiency manage metabolic disorders effectively worldwide.
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