Expertise

Formulation

FTUP provides product development services in compliance with the latest regulatory guidance. Our product development offers Quality-By-Design (QbD) concepts at all stages of formulation development. Design of experiments (DOE) along with risk assessment strategies allow us to design our experimental plan. Our development approach allows us to meet our delivery timelines and helps us in providing our clients with cost-effective drug delivery solutions. FTUP has an expertize in process optimization and and supports process validation and technology transfer up to commercial batch-size manufacturing for all dosage forms. FTUP’s product development services include pre and post-formulation regulatory compliance activities.

FTUP understands process automation and the principles of PAT in process development and process controls.

FTUP can take partial and whole assignments in product development that includes pre-formulation, compatibility studies, formulation development, process development, defining critical attributes and defining control strategies to get reproducible results. FTUP can successfully take products from small scale to exhibit batch to commercial scale-ups. FTUP has successfully made bioequivalent products and understands the IVIVC basis of correlations.

Pre-formulation studies

Pre-formulation Studies may include but not limited to:

  • Polymorph Screening & Selection
  • Particle size characterization
  • Salt Form Selection
  • pH Solubility & Stability
  • Solid-state & Solution-state Stability
  • Photo-stability
  • pKa& Partition Coefficient Determination
  • Hygroscopicity
  • Morphology Assessment
  • Solubility Studies
  • Excipient Compatibility
  • Flowability

Formulation Development

Formulation development may include but not limited to:

  • Offering Quality-By-Design (QbD) concepts at all stages of formulation development
  • Development of IR to SR dosage forms.
  • Modified Release oral pellet formulations
  • Development of soft chewable dosage forms.
  • Development of transdermal dosage forms
  • Development of topical dosage forms such as Roll-ons, spray patches, creams, ointments, gels, etc.
  • Development of dry powder for reconstitution
  • Development of liquids (solutions, suspensions, emulsions) products
  • Alternative pharmaceutical dosage forms

The above are just a few examples but we can take up projects that are novel and unique. FTUP can take up consultancy based on customer requirements.

ACHIEVEMENTS

NDA AND ANDAS FILED

Approved NDA:

Approved ANDAs:

  • Fingolimod Capsules, 0.5 mg
  • Prasugrel Hydrochloride Tablets, 5 mg And 10 mg
  • Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg And 100 mg
  • Methylphenidate Hydrochloride Tablets USP, 5 mg, 10 mg And 20 mg
  • Methylphenidate Hydrochloride Extended Release Tablets USP, 10 mg And 20 mg
  • Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg And 10 mg
  • Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate Tablets (Mixed Salts Of A Single Entity Amphetamine Product), 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg
  • Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, And 120 mg

LIST OF ANDAS SUBMITTED

  • Dronedarone Tablets, 400 mg

OTC

  • Cushion Grip
  • Lidocaine 4% Patch
  • Allergy Relief Diphenhydramine Hcl, 25 mg Antihistamine Chewable Bars
  • Allergy Relief Diphenhydramine Hcl, 12.5 mg Antihistamine Chewable Bars
  • Gas Relief Simethicone 250 mg Soft Chewables

FTUP has hands-on experience in handling controlled substances and psychotropic drugs, as it has developed and supported several such molecules as seen in the filed ANDA list.