R & D ACTIVITIES
Facility

Our R & D Department occupies a 10,000 ft2 cGMP facility. This facility has a DEA license for schedule I - V products.
Development Team

Our talented team of R & D scientists are busy developing ANDAs and 505(b)2 NDAs. They have extensive experience with over 45 different active pharmaceuticals ingredients (API) and have developed patent-pending delivery systems.
Analytics

The analytical group is competent in the development and validation of analytical methods that meet the stringent requirements for filed products. They follow guidelines for USP/NF, EP compendial testing.

We have experience developing the
following dosage forms:


 Oral Tablets
  • OTC, Rx Only, and Narcotics
  • Immediate-release
  • Sustained-release
  • Modified-release
  • Sublingual
  • Quick-dissolving
  • Chewable
  • Bilayer
  • Coated
 Oral Capsules
  • OTC, Rx Only, and Narcotics
  • Powder-filled
 Oral Solutions and Suspension
  • OTC, Rx Only, and Narcotics
  • With or without sugars, dyes, or alcohols
 Topical Solutions
 Otic Preparations

Key activities supported for an ANDA or 505(b)2 NDA
  • Prepare development plan
  • Evaluate API, excipients, and packaging materials
  • Review and evaluate stability of API
  • Verify analytical methods of API
  • Conduct pre-formulation and formulation activities
  • Request and attend pre-IND meeting with FDA (NDA only)
  • Develop and validate test methods
  • Perform cleaning verification studies
  • Manufacture exhibit batch
  • Conduct ICH stability studies
  • Submit IND (NDA only)
  • Coordinate BA/BE Biostudies
  • Assemble application
  • Submit ANDA or NDA in eCTD format
  • Support pre-approval inspection
  • Manufacture commercial batches
  • Perform process validation testing



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