OTC (Over the Counter)

• Innovator Companies
• Generic Companies
• Biologics Companies
• Biosimilars Companies
• CRO (Clinical Research Organization)
• CDMO (Contract Development and Manufacturing Organization)
• CMO (Contract Manufacturing Organization)
• Raw Material & Intermediates
• API (Active Pharmaceutical Ingredients)
• Pharma Research & Development (R&D)
• Excipients
• Formulation (Drug/Biologics)
• Packaging Materials
• Medical Devices
• Analytical Labs
• OTC (Over the Counter)
• Cosmetics
• Nutraceutical
• Food/Dietary Supplement
• Veterinary

Pharmaceutical Over the Counter (OTC) companies specialize in the development, manufacturing, and distribution of medications that can be sold directly to consumers without a prescription. These products are typically used to treat common ailments such as pain, fever, allergies, digestive issues, and minor skin conditions. OTC medications undergo rigorous wing and regulatory approval processes to ensure their safety, efficacy, and suitability for self-administration by consumers.

• New OTC Drugs: New OTC drugs must undergo a rigorous approval process, which includes submitting a New Drug Application (NDA) (in the U.S.) or similar dossiers to national authorities. The application must provide evidence of the drug’s safety, efficacy, and quality, supported by clinical trials and other data. Some drugs may be eligible for approval via Abbreviated New Drug Application (ANDA), particularly if they are generic versions of an approved OTC drug.
• OTC Monograph System (U.S.): For certain categories of OTC drugs, the FDA uses an OTC monograph system. Under this system, drugs that fall into a predefined category (e.g., antacids, antihistamines) do not require individual approval. Instead, they must comply with the applicable monograph, which sets out the acceptable ingredients, dosages, labeling, and other requirements. This system allows for faster market access and can simplify the approval process for commonly used OTC products.
• EU and Other Countries: In the EU and other regions, OTC products must comply with established marketing authorization procedures. These could be simplified if the product is already approved in another jurisdiction or falls under mutual recognition agreements between regulatory bodies.

Masuu will be Supporting the submission process to FDA if the product falls outside the monograph, requiring a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for approval.

Masuu offer regulatory support for OTC products, including labeling compliance, regulatory submissions, and quality management. Our services ensure that your OTC products meet all regulatory requirements and reach the market efficiently.