O.T.C. (Over The Counter) Drugs
Pharmaceutical Packing Contractor
The process of contract manufacturing an OTC drug is an important aspect of America’s healthcare system, with numerous steps involved. In order to legally launch an OTC drug, it must comply with the OTC drug monograph assigned by the FDA, which outlines acceptable ingredients, doses, formulations, and labeling.
Once the final monograph is published, an OTC manufacturing company can begin the process of creating and marketing their product without requiring pre-approval from the FDA. This process involves selecting active ingredients, developing the formula through experimental batches and lab testing, selecting an appropriate container or closure system, establishing formal specifications for raw materials and finished drug products, validating testing methodologies, determining the product’s expiration date through stability testing, creating accurate labeling artwork, validating the process equipment and operating parameters, and finally submitting a Drug Listing Form to the FDA.
Overall, the process of contract manufacturing an OTC drug involves careful attention to detail and compliance with FDA regulations in order to ensure the safety and effectiveness of the final product.
Once the final monograph is published, an OTC manufacturing company can begin the process of creating and marketing their product without requiring pre-approval from the FDA. This process involves selecting active ingredients, developing the formula through experimental batches and lab testing, selecting an appropriate container or closure system, establishing formal specifications for raw materials and finished drug products, validating testing methodologies, determining the product’s expiration date through stability testing, creating accurate labeling artwork, validating the process equipment and operating parameters, and finally submitting a Drug Listing Form to the FDA.
Overall, the process of contract manufacturing an OTC drug involves careful attention to detail and compliance with FDA regulations in order to ensure the safety and effectiveness of the final product.