Topical lidocaine cream is used to numb a localized skin surface area. There are only a few lidocaine cream contract manufacturing suppliers in the United States. There are certain regulatory requirements that lidocaine cream contract manufacturing firms are required to follow.
These requirements for lidocaine cream contract manufacturing companies are required to follow are?
They must register with the FDA and State Health Departments. Not all lidocaine cream contract manufacturing facilities are properly registered to make OTC medications. Be wary of those lidocaine cream contract manufacturing companies that cannot demonstrated their capability of registering your product with the FDA. In Texas, those who distribute topical lidocaine products also need to register with the State Health Department as OTC medication distributors. If a supplier of lidocaine cream contract manufacturing cannot warrant their capability to follow these regulatory procedures – RUN far away!
All OTC medications must be registered with the United States Food and Drug Administration. (US FDA or FDA). If they do not, they are not legal for sale in the United States. This will expose you to potential regulatory issues.
Appropriate legal dose concentrations of lidocaine cream contract manufacturing is 4% for skin and 5% for ano-rectal use. Anything over those concentrations is not compliant and also exposes you to potentially serious regulatory issues in the US, since these products are therefore, considered Rx.
Once you have identified a legitimate contract manufacturer or manufacturer’s agent you can begin your process. You manufacturer or agent will be able to guide you through the full process. Sambria Pharmaceuticals supplies a proprietary lidocaine cream for contract manufacturing. The Company brand is NeuroMed 7. This products is safe, effective, has a fast onset and regulatory compliant. Sambria Pharmaceuticals also supplies this proprietary formulation in private label for its distribution customers wishing to supply it.
Your provider of lidocaine cream for contract manufacturing should be able to assist you in formulating a product that is both safe and effective as well as one that does not infringe on others’ patents. Formulations should include skin penetration enhancers, also known as, drivers. The reason for this is that the lidocaine molecule will have a very difficult time penetrating the barrier layer of the skin known as the stratum corneum. This layer has the job of keeping toxins and pathogens from entering the deeper layers and the internal tissues. If your formulation does not included drivers it will not be effective.
Prior to producing your topical lidocaine cream, make sure to do a patent search to ensure you do not infringe on anyone else’s patents. Legitimate manufacturers will NOT produce a product that is owned by someone else without written permission.
Sambria Pharmaceuticals supplies its customers with a proprietary lidocaine cream formulation under its own NeuroMed 7 brand as well as in private label form for OTC Human Use.
This product is supplied in single-use, sanitary packets only. This provides you with a unique form of packaging of the Company’s safe and effective, proprietary topical lidocaine cream formulation.
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