Formulation and cGMP Manufacturing of Tetracycline 3% Ointment/Cream

Project Description

FDA Registered and cGMP Contract manufacturer needed for formulation and cGMP manufacturing of tetracycline 3% ointment/cream in compliance with OTC monograph and the following:
1) Compliance with OTC monograph ? Ingredients, concentration, and purpose should be in accordance with the OTC monograph.

2)OTC drug labeling ? The content and format of the labeling should be in accordance with FDA OTC drug labeling requirements.

3) Establishment Registration ? Manufacturing facilities involved in manufacturing, packing, and processing the drug must be registered with the FDA.

4) NDC drug listing ? Drug listing is a mandatory requirement for all the drug products marketed in the USA.

5) GMP (Good Manufacturing Practice ) ? Manufacturing of the product should be in accordance with Good Manufacturing Practice as defined in the 21 CFR 210 and 211.

6)US Agent Appointment ? Foreign facilities must appoint US Agent for FDA communication purposes.