Antacids are over the counter (OTC) drugs that helps with indigestion and heartburn by neutralizing stomach acids. Usually, antacids come in chewable tablets or liquid can be purchased from pharmacies without any prescription.
The active ingredients used in antacids vary depending on the type of brand. The most common ingredients are as below.
- Alginate.
- Aluminum hydroxide.
- Calcium carbonate.
- Magnesium carbonate.
- Magnesium hydroxide.
- Magnesium trisilicate.
- Sodium bicarbonate.
To market Antacids in the US, below are process the company must comply with.
- Drug establishment registration
- Product listing
- Label compliance
- cGMP regulations
1. Drug Establishment Registration
Every domestic or foreign establishment that manufactures, repacks, or relabels drug products (including antacids) for the U.S. market must register with the FDA.
- Timing: New facilities must register within 5 days of beginning operations.
- Renewal: Registration must be renewed annually between October 1 and December 31.
- Verification: Registration can be verified at https://www.accessdata.fda.gov/scripts/cder/drls/
2. Product Listing
- Registered facilities are required to list all drug products they market. Each product is assigned to a unique National Drug Code (NDC).
- Compliance: Most antacids marketed under OTC Monograph M001.11, which sets standard rules for safety.
3. Label compliance
- Labels must include “Drug facts’ with indications, warnings, direction of use and contact information to report adverse events.
Liberty Management Group , as a leading FDA consultant will provide assistance with drug establishment registration, drug listing and label review.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us