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Part of US based
Semler Group of Companies,
in business since 1946

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Formulation & Analytical Development

Formulation Development

Our expertise in formulation development extends to the development of all conventional dosage forms. Our strategic alliances broaden the scope to consider many Novel Drug Delivery Systems (NDDS), including transdermal & liposomal delivery systems. We consider multiple approaches to improve the bioavailability of drugs. We are constantly expanding our capabilities, including in our repertoire additional modules and suites to develop oncology and high potency compounds.

Collectively, we have the experience to formulate oral solids, dermatologicals, parenterals, ophthalmic suspensions and ointments. We have expertise in improving delivery of poorly soluble/ permeable drugs and the capability to screen potentially innovative drugs based on pharmacokinetic properties. We possess pelletization, drug-layering, particle-coating and other technologies to achieve extended release profiles for tablets or capsules.

Analytical Development

Our analytical development services include assay and RS method development and validation, dissolution method development and validation, stability studies as per ICH guidelines, polymorphic form characterization (DSC/TGA/XRD/Microscopy), cleaning validation studies and HPLC to UPLC method conversions.

Generics and NCEs

  • Pre-formulation
  • Proof of Concept studies
  • Phase Appropriate CT Formulations
  • Formulation and Process Development
  • Scale-up and Technology Transfer
  • Life cycle management
  • Differentiated generics, 505 (b) (2)

Dosage Forms

  • Tablets – Immediate Release, Modified Release
  • Capsules – Immediate Release, Modified Release
  • Oral Liquids / Suspensions / Ointments
  • Injectables and Ophthalmics – Liquids / Suspensions
  • Topicals – Ointments / Creams / Gels
  • NDDS
    • Liposomes
    • Transdermals
    • Liquid filled hard gelatin capsules
 

About This Service

SRC offers top-notch scientific expertise across dosage forms and modes of administration. Our scientists have several decades of experience in developing products for US, EU, India, Brazilian, Turkish, South African & other markets across diverse therapeutic areas.