Over-the-counter (OTC) medicines are the medicines/drugs that are sold directly to public/consumer without any prescription. People use OTC medicines in a variety of illnesses like pain, headache, coughs and colds, diarrhea, constipation, acne etc. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products.

Acetaminophen, Aspirin, Antacids, Decongestants, Antihistamines and Laxatives are some examples of the OTC products.

Some OTC medicines have active ingredients with the potential for misuse at higher-than-recommended dosages. So, we must ensure that its quality and safety are maintained in compliance with the Regulatory Bodies. All OTC drug products have to meet FDA quality, effectiveness and safety standards.

Services at Chromak Research

We at Chromak Research offer various services to OTC manufacturers, scientists, and formulators that includes microbiological, analytical, physical and sensory capabilities testing along with labeling and guidance services as per the client demands.

We have well equipped state-of-the-art ISO 17025 certified laboratory with cGMP practices that can check the purity and potency of raw materials and finished products under the standard protocols (USP, EP, JP, FCC, ASTM etc.) to comply with strict regulatory requirements.

OTC Product Testing includes:

  • Raw Material, API and Excipient Testing
  • Stability Study
  • Monograph Testing
  • Formulation/Process Development
  • Contaminant ID & Failure Analysis
  • Bio equivalency testing
  • Method Development and Validation
  • Identification, Strength, Quality and Purity Test
  • Impurity Test (Heavy Metal, Residual Solvents and Contamination)
  • Antimicrobial Preservative Effectiveness Testing
  • Water Test
  • Container Closure System
  • Storage Condition Tolerances