Our products are currently marketed in Europe, the United States, Canada, South Korea, South Africa, Brazil, and the Middle East. We provide private label distributors with documents for their country`s legal registration of our products as Over-the-counter medications without prescriptions. 

The product registration documents required by most countries are:

  • Product certificate of analysis,
  • Ingredients certificate of analysis,
  • Certificate of free sale,
  • Certificate of origin,
  • Our company`s state license 
  • FDA facility registration documents,
  • Product NDC number as OTC with the FDA,
  • Product Stability test reports,
  • Product Microbiology test
  • Batch production records
  • Product order invoices.

For OTC tablets (oral solid dosage) additional test reports required are:

  • Tablet friability test,
  • Tablet disintegration test report,
  • Tablet dissolution test,
  • Tablet moisture test report,
  • And shelf-life reports

 Please crosscheck with your country`s registration requirements if different from these, send them to us before we export your products. The minimum quantity registrable is 50,000 copies per line. Quantities less than this is not eligible. Our products are currently legalized and approved by the USA-FDA, ANVISA, EMA, CANADA HEALTH, MHRA, NMPA, PMDA, and WHO. Submit your countries requirements to our Regulatory Affairs Division via email at: QCTEAM@AMWINER.COM Please note: it is not possible to register a product without having the actual product made and tested. The test reports will be conducted after the products are made, and the documents generated from the existing product.

Raphe Pharmaceutique FDA Over the Counter (OTC) Drug Approval Consulting Services

Over the counter (OTC) drug products are defined as drug that do not require a medical prescription. They are safe and effective for use without treatment from a healthcare provider. The FDA reviews the active ingredients and labeling of these OTC drug. There are over 300,000 OTC drug products marketed in the United States. The FDA conducts a regulatory review that is based on the active pharmaceutical ingredient and labeling by therapeutic class rather than by evaluating individual drug formulations.

Firms intending to market a new product or OTC drug must submit an NDA (505) (b)(1) or 505(b)(2) application. Meeting FDA requirements can be a long process in most cases. An experienced staffs can assist you with the complicated process of submission, compliance and filing.

The two regulatory pathways for OTC drug in the United States are firstly, development under the OTC monograph process: or secondly, through the New Drug Application (NDA) process. Products that do not meeting the conditions of the OTC drug monograph must seek approval through the NDA process.

Our services as an FDA Over the Counter Drug Approval Consultants include:

  • Drug classification
  • Labeling assistance
  • OTC drug monograph applications
  • Prescription to OTC switch applications
  • Preparation of Time and Extent Application (TEA) for OTC Drug Monograph amendment
  • Assistance to meet post-approval requirements
  • US Agent

Our in-house consultants work with you through all the phases of the process and ensure timely approval and marketing of your OTC product. Our compliant department is well experienced with regulatory strategies to ensure prompt and speedy FDA compliance in all phases of the approval process. We have over two decades of experience in assisting firms with the FDA approval pathway for OTC drug.

Our consultants have an in-depth understanding of FDA regulations and can determine the appropriate drug classification (monograph or ANDA) and also help prepare compliant labels according to the OTC drug monograph. What’s more, our consulting services are quicker and more cost-efficient than other firms in this domain.