We offer a wide range of scalable contract development and manufacturing capabilities for diverse and complex dosage forms including: Immediate release tablets and capsules, Controlled release (CR), extended release (ER), and modified release (MR) tablets and capsules, Mini tablets, Fixed dose combination products, and Powder and Spheres in sachets.
Our experts maintain the integrity of your double-blind studies with the design, development and manufacture of placebos and trial doses that match your drugs and existing comparators.
Supporting phase I-IV development and reformulations, our GMP manufacturing teams are supported by integrated IND-enabling research and development services, including analytical, pre-formulation and formulation services.
Solid Oral Dose Solutions
Our teams have extensive experience in developing various dosage forms for challenging small molecules, highly potent compounds, and even DEA controlled substances (Class I through Class V). Our capabilities include:
- Blending
- Granulation
- Coating
- Compression
- Encapsulation
- Over-encapsulation
- Immediate release tablets and capsules
- Controlled release (CR), extended release (ER), and modified release (MR) tablets and capsules
- Mini tablets
- Fixed dose combination products
- Powder and Spheres in sachets
Liquids and Semi-Solids
- True Solutions
- Nasal Sprays
- Powders for reconstitution/suspension
- Gel formulations
Sterile fill-finish
Sharp offers 100% isolator-based sterile filling, lyophilization, formulation development, analytical support, stability studies and terminal sterilization. Our fillers have the flexibility for syringes, vials and cartridges to be filled on the same line.
Sharp also provides global comparator sourcing, procurement, and blinding to ensure the scientific credibility of your clinical trial.
With commercialization in mind, our drug development and GMP manufacturing services help you achieve optimum results for your clinical trial and commercial scale-up.
Our expert team of manufacturing and R&D scientists between them have years of experience preparing IMP for clinical trial. Let their experience be your strength.
Clinical Trial Manufacturing Services
- Sterile development & manufacturing
- Dry blending (direct compression), wet granulation (high shear, low shear & fluid bed top spray)
- Tablet compression and film coating
- Encapsulation and over-encapsulation
- Manufacture of clinical supplies
- Phase I-IV development and reformulations
- Placebo manufacturing
- Comparator sourcing and blinding
- Global comparator procurement
Dosage Form Manufacturing
- Injectables
- Syringes
- Vials
- Cartridges
- Oral Solid Dose
- Immediate-release tablets
- Controlled-release tablets
- Capsules
- Multi-fill
- Neat active powders
- Blend
- Liquids
- Semi-solids
- Powders and dry powders
- Suspensions
- Emulsions
- Gels
- Creams
- Ointments
- Lotions
