DCS PHARMA
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Formulation Development

Formulation Development

We offer fully integrated product development for a wide variety of dosage forms which includes, but is not limited to tablets, Capsules, Dry powders for suspension, Liquids, Injections, Oncology (solid orals and injections), Lyophilized products, Nano-suspensions, Nano-emulsions, Potent drugs, and Eye drops. Our expertise in the areas of product development and technology transfer will make us a trusted partner with clients from development to commercialization.

CAPABILITIES

We can work on very challenging projects on solids, liquids, injections and topicals which makes us a preferred partner. Our decades of experience in formulation development helps our partner to complete the project on time with quality and budget. Our QBD based formulation development helps our process easily scalable and reproduce commercial lots successfully.

  • Product development is based on - Design Development Protocol and Process is based on CCP - Critical Control Points model.
  • Product development includes development, regulatory compliance, vendor establishment with study supply of ingredient, stability, NABL approved lab testing guidance and support in establishing manufacturing process by 3 scale-up batches.
  • Our support encompasses novel product development in various dosage forms including Orals like Tablets, Capsules, Powders, Liquids, beverages, gummies & cereal-protein bars, Topicals like Creams, Ointments, Lotions, Gels etc., Sterile dosages like injections (Liquid & Lyo), Liposomal, Emulsions etc., at our Innovation Centre at Hyderabad , India and can support in creation and validation of novel processes, ingredients qualification, patenting processes.
  • Scale up and Exhibit batches support at CMO sites
  • BE studies support
  • BE studies supportProcess Validation Support – Validation Planning, Protocol preparation & Execution, and Final Summary Report (FSR) write-up.

PARTNERING

  • Full life cycle management from initial product development to manufacturing.
  • The client will be notified on all aspects of formulation, analytical & process development up to manufacturing & approval.
  • We offer clients to partner with us from any stage of Product development & willing to have a long-term trusted business relationship.
  • We offer clients to partner with us from any stage of Product development & willing to have a long-term trusted business relationship.

INJECTIONS

  • Lyophilized powder for solution
  • Suspension
  • Solution
  • Emulsion

TABLETS

  • Bilayer tablets, Delayed release tablets, Sustained release tablets & Extended release tablets
  • Immediate release tablets (highly insoluble molecules possessing bioequivalence challenges)
  • Highly sensitive molecules possessing physical and chemical incompatibilities
  • Hydrogel based drug delivery system
  • Osmotic drug delivery system
  • MUPS tablets (Pellets compressed into tablets)
  • Gastro retentive system (targeting stomach and intestine)
  • Delayed release ODT formulations
  • Orally disintegrating tablets
  • Taste masked ODT formulations
  • Chewable tablets

CAPSULES

  • Immediate and delayed release formulation comprising of simple and challenging molecules.
  • Pellets/powder filled into capsules
  • Mini tablets into capsules
  • Hydrogel based mini tablets into capsules

SPECIALITY PRODUCTS

  • We provide technical and development support on customer specific specialty products like NDDS and 505(b)2 products

PELLETS

  • Delayed release pellets
  • Drug layered pellets
  • Pellets compressed as tablets
  • Pellets compressed as ODT formulation

OTHER DOSAGE FORMS

  • Eye drops
  • Powder for suspension
  • Dry powder into sachets
  • Syrups