Over-the-counter pain relief, first aid, sanitization, anti-itch, and other monograph-regulated products require a level of manufacturing rigor that most contract manufacturers can't provide. PMG's facilities are FDA-registered, NDC-listed where required, and built for monograph compliance.
From monograph-regulated topical analgesics to FDA-listed sanitizers and specialty OTC formats, we handle the categories that demand pharmaceutical-grade manufacturing.
OTC products are regulated under the FDA monograph system, which defines exactly which active ingredients are permitted, at what concentrations, for what claims. Our chemists formulate within the monograph from day one.
OTC labeling is the most regulated labeling in consumer products. Every element of the Drug Facts panel has specific requirements. Errors trigger Warning Letters and retailer rejections.
Manufacturing OTC products requires FDA-registered drug establishment facilities. Our facilities maintain these registrations as a baseline.
OTC products are regulated under the FDA OTC drug review system and its successor monographs. Manufacturing facilities must hold drug establishment registration; products must hold NDC listings; labeling must follow the Drug Facts format precisely. The 2020 CARES Act updated the OTC monograph reform process, accelerating review timelines for some monographs while introducing new user-fee structures. We track these changes so your product launches within the current framework.
OTC manufacturing rewards manufacturers who treat it as the pharmaceutical-adjacent discipline it actually is — and punishes everyone else with Warning Letters and recalled inventory.