That means they are held to a higher regulatory standard than dietary supplements or confectionery products.
Pharmaloz is built for exactly that standard. Our facility operates under FDA 21 CFR Parts 210 and 211, which is the same compliance framework applied to prescription drug manufacturing.
Menthol cough drops and throat lozenges
Honey-lemon and herbal throat soothers
Benzocaine anesthetic lozenges for oral pain relief
Sore throat medicated lozenges
Combination cough, cold, and throat formulas
Custom medicated formulations developed to your specifications
We manufacture across the core OTC medicated lozenge categories that drive the consumer healthcare market.
Every product is formulated and manufactured in compliance with applicable FDA drug monographs.
For OTC drug products, compliance is not a differentiator. It is a requirement. The question is whether your manufacturer can demonstrate it consistently. Pharmaloz can.
Our facility has maintained pharmaceutical-grade compliance for over 35 years across every production run.
Under 21 CFR Parts 210 and 211
Across all OTC product lines
At every stage of production
And traceability for every production run
For full FDA monograph compliance
We work with OTC brands, regional consumer healthcare companies, and retailers that carry store-brand medicated lozenge products.Whether you are managing an established product line or launching a new OTC lozenge, our team has the regulatory knowledge and manufacturing infrastructure to support you.
With existing OTC lozenge products
With private label OTC programs
Reliable US manufacturing partner
Entering the US OTC market
Most lozenge manufacturers focus on the confectionery or supplement side of the market. Pharmaloz has built its facility and its processes around pharmaceutical-grade OTC manufacturing.
That depth of regulatory experience is what separates us from manufacturers who treat OTC compliance as an add-on.
