About Us

AMF Pharma provides licensed cGMP manufacturing for your OTC drug needs.

Specializing in custom and private label services, we deliver superior-quality OTC products driven by excellence and integrity. Our expertise ensures strict adherence to quality standards, providing reliable manufacturing and outstanding value. Partner with us for competitively priced, compliant OTC solutions. We offer 300k tablets/capsules or 5~10k vials* as our minimum order of quantity with the lead time from 4-8 weeks*.

As a full service OTC drugs manufacturer, we constantly seek to expand the horizon of our company, our clients' businesses and confidence.

*The quantity and lead time are subject to change according to the product specification and complexity, material and production availability.

Service

We Offer Turn-Key Custom Manufacturing Services For OTC Drugs

Partner with AMF Pharma to build lasting customer trust for your OTC products! We are the ideal solution for companies like yours, seeking a multi-service, fast, reliable, and efficient custom manufacturer specializing in high-quality, compliant OTC pharmaceuticals and private label solutions.

Formulation development to determine the optimal dosage form, composition, and manufacturing route is a fundamental part of robust OTC pharmaceutical product development. At AMF Pharma, we recognize the critical importance of developing stable, effective, and compliant formulations for our clients.

Our dedicated Research and Development team possesses extensive experience in developing a wide variety of OTC drug formulations, working with diverse active pharmaceutical ingredients (APIs) and excipients. Our facilities are designed with flexibility, capable of handling a wide variety of batch sizes to support the optimization and scaling of your formulation. Our formulation development capabilities cover a broad range of dosage forms common in the OTC market, including tablets, capsules, liquids, softgels, and topical drug formulations.

Furthermore, our experienced team provides crucial support to help clients navigate the regulatory process, including assisting with FDA compliance and OTC Product Listing requirements.

Quality

We are unwavering in our commitment to the quality, safety, and efficacy of the OTC pharmaceutical products we manufacture. All products produced at AMF Pharma facilities strictly adhere to current Good Manufacturing Practice (cGMP) as set forth in the Food, Drug, and Cosmetic Act.

Our manufacturing facilities are subject to rigorous internal quality audits and prepared for external regulatory inspections to ensure steadfast adherence to Standard Operating Procedures, comprehensive employee training programs, defined product specifications, and stringent raw material and supplier qualification procedures.

AMF Pharma's robust Quality Management System ensures that all manufacturing Standard Operating Procedures (SOPs) are meticulously followed, guaranteeing consistent and reliable product quality and compliance with all applicable regulatory requirements.

certification

All our processes and systems are certified as compliant with cGMP standards by UL Registrar LLC. We are also a manufacturer registered at the California Department of Public Health. All of our production facilities meet or exceed US FDA criteria.

About Us

Service

We Offer Turn-Key Custom Manufacturing Services For OTC Drugs

Quality

certification

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