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Product Quality

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Product Quality

Regulatory Compliance

Apotheca is an FDA registered manufacturing facility and we comply with all FDA regulations. With our extensive experience in regulatory compliance of over-the-counter products, we can advise and assist with all requirements for FDA product indications, label copy, and ingredient listings. The FDA requires that all multi-ingredient over-the-counter remedies provide symptom relief, and we are able to guide you in making the appropriate “symptom relief” claims on your packaging. We will also file the appropriate drug product listing with the FDA for all over-the-counter drug products manufactured for U.S. sales.

Product Consistency and Reliability

At Apotheca, every step of the manufacturing process is well documented according to FDA guidelines. With quality raw materials, standardized manufacturing processes and stringent product testing, we are able to produce products for you that will be consistent, order after order.

Product quality ingredientsIngredients

We obtain raw ingredients and materials from ethical and reliable suppliers worldwide. We use organic, gluten-free alcohol made from non-GMO corn, and we use state-of-the art USP purified water systems for all dilution involving water.

Quality Control Testing

All incoming raw materials are quarantined until identity and quality testing are completed. Certificates of Analysis are requested from all raw material providers.

All water used in the manufacturing process is subjected to microbiological testing and purified water testing according to USP (United States Pharmacopeia) standards.

No finished product is released until it has passed Apotheca’s rigorous series of finished product testing.

Facilities

Production FacilitiesApotheca manufactures all products in its own facilities located in Woodbine, Iowa. We are one of a small number of authorized homeopathic manufacturing facilities in the United States. Apotheca is registered with and subject to inspection by both the Food and Drug Administration (FDA) and the Iowa Department of Inspections and Appeals. We follow all current good manufacturing practices (cGMPs) as set forth by the FDA.