We are seeking reliable pharmaceutical partners for the licensing (CTD/eCTD dossier) and/or contract manufacturing of an established second-generation antihistamine in a patient-friendly formulation:

• Desloratadine 5 mg

• Dosage form: orodispersible tablets (ODT), pack size: 10 pcs

• Therapeutic area: allergic rhinitis, chronic idiopathic urticaria

• Administration: without water, ideal for pediatric and adult populations

• Regulatory pathway: national / MRP / DCP

• Market status: OTC or Rx depending on region

• Target markets: EU, MENA, LATAM

We are looking for:

• Ready-to-register CTD/eCTD dossier, preferably supported by biowaiver or literature references

• GMP-certified contract manufacturing partner with proven experience in ODT formulations (direct compression or lyophilized forms)

• Capability for taste-masked formulations, blister packaging, and regulatory support (QRD, PIL, artwork)

Preferred production locations: Europe or Turkey