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Differentiated product development
(505(b)(2)/EU Hybrid application

Driving patient-centered innovation with unique delivery technologies for differentiated products.

Product differentiation is a core business strategy for the big pharma organizations as much as it is for the smaller players, often giving those smaller pharma organizations a chance against larger rivals.

Repositioning and repurposing of well established, commercially available drugs via the US 505(b)(2), the European 10(3) Hybrid and Canadian SRTD regulatory pathways is a growing trend as the cost of new drug development increases. Many of these repurposed drugs lack patent protection.

We will use its patent protecting delivery technologies to design, formulate and develop differentiated, yet cost-effective new products, with extended patent protection in key markets like North America, Europe and Latin America.

Key steps involved in differentiated dosage forms:

  • Identifying the appropriate differentiation elements like patient compliance, ease of dosing and many more.

  • Creating design map to balance risk of failures and increase chances of success.

  • Studying IP landscape and creating own IP around it. 

  • Execution of strategy and assessing outcome at every stage gate.

  • Finetuning the next steps as per project to reach end goal. 

Differentiated dosage forms mainly being developed

  • Oral solids to oral Liquids

  • Taste masking

  • Enhancing Bioavailability

  • Immediate release to modified release

  • Lyo injections to ready to use injections

  • Injections to Oral delivery

  • New combinations for additive or synergistic effects

Why Concresco ?

Innovative Product Development

Dosage Form Proficiency

Global Expertise

ExperiencedLeadership Team

Extensive Industry Network

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