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Product Development

Our dedicated project managers and of subject-matter-experts have successfully developed and transferred a wide range of drug products and dosage forms, supporting diverse regulatory approvals (505 (b) (1), 505 (b) (2), ANDA). Hydra Pharmaceutical can meet your product development and site-transfer needs.  We offer turnkey solutions, and our experts in formulation development, scale-up process, analytical method development & validation and packaging, will see your product through initial development phases until completion of process validation. We can also support your pre-IND activities.  

Type of products

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Type of products

FormPackaging

Semi-solid (cream, lotion, ointment, gels) Tube, pump sprays, airless pumps, jars, bottles, syringe applicators, sachet, stick-packs 

Liquid (oral, otic, nasal or topical) Pump sprays, airless pumps, jars, bottles, syringe applicators, metered-dose sprays, sachet, stick-packs, towelettes 

Suspension (oral, otic, nasal or topical) Pump sprays, airless pumps, jars, bottles, syringe applicators, sachet, stick-packs, towelettes 

Formulation and Process Development

Critical work of providing your product with the desired characteristics to achieve the targeted safety and efficacy profile starts with the elaboration of an optimal formulation.  To this end, we offer:  

  • De Novo formulation, deformulation or optimization of an existing formulation 

  • Quality by Design (QbD) and Design of Experiments (DoE) 

  • Technical transfer and scale-up (clinical, exhibit, commercial) 

  • Selection of packaging components 

  • Preparation of the complete data package for regulatory filing

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Clinical Development

Our expertise is focused on semi-solid, liquid and suspension dosage forms to ensure cutting-edge solutions to today’s drug development requirements. We offer: 

  • Small scale manufacturing and packaging for pre-clinical studies 

  • Supply of cGMP clinical material of Phases I to III 

  • Storage of products for future studies 

  • Product stability program  

  • Customized packaging and labeling 

Pharmaceutical Distibuitor

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List of APIs

Our team can provide you with a full turn-key service, from sourcing raw materials and packaging components, to serialization and distribution of even the most logistically challenging products. We can take care of your entire supply chain, providing you with a cost-effective option to confidently dedicate your resources to other priorities. 

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About us

‎Hydra Pharmaceutical is a Contract Development and Manufacturing Organization (CDMO) founded in 1994. Over the years, we have developed expertise in the development and manufacture of liquids, suspensions, semi-solid and injectable drug products. This strategic focus has allowed us to establish unique expertise to support your product development and manufacturing needs, which, combined with our operational flexibility and commitment to on-time delivery, allows us to operate as an extension of your team. ‎

‎Our business is 100% fee-for-service and exclusively focused on contract services. We're here to help you meet your company goals, not compete with you.

CONTATO
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