Last updated: June 8, 2026
Imodium A-D is the U.S.-market branded anti-diarrheal with the active ingredient loperamide. Supplier identification depends on (1) the exact listed NDA strength and dosage form (capsules/tablets/liquid) and (2) whether the source is the branded manufacturer, contract manufacturers for commercial supply, or API/trader distributors. With only the product name “IMODIUM A-D” provided, a complete, accurate, citation-backed supplier map cannot be produced.
Who supplies the active ingredient for IMODIUM A-D (loperamide hydrochloride)?
Answer: Loperamide HCl is supplied by multiple global API manufacturers and distributors; the exact approved API source for the U.S. branded supply chain is not derivable from the product name alone.
Which API manufacturers make loperamide hydrochloride used for IMODIUM A-D?
Answer: Multiple firms produce loperamide HCl globally; the approved supplier list for the specific Imodium A-D U.S. NDA cannot be tied to the brand without the NDA and label/Orange Book listing.
What is the common contract-manufacturing model for OTC anti-diarrheals like IMODIUM A-D?
Answer: Brands typically use a mix of in-house manufacturing and contract manufacturing for solid oral dosage forms, with separate sites for blending, granulation/compression, coating (if applicable), and packaging. Exact sites for Imodium A-D require NDA-specific documentation.
Which companies manufacture IMODIUM A-D finished dosage forms?
Answer: “IMODIUM A-D” finished dosage suppliers include the NDA holder and any contract manufacturing organizations on the labeled product. The specific set of manufacturing sites cannot be confirmed from the brand name alone.
Are IMODIUM A-D tablets or capsules produced by the same manufacturer?
Answer: Not necessarily. Different strengths and dosage forms can be produced on different lines and sites, sometimes with different packagers and packaging configurations.
What manufacturing steps usually change across IMODIUM A-D packaging variants?
Answer: The API and core formulation can stay constant while packaging components and labeling, serialization, and blister/bottle configurations change by SKU and regulatory requirements.
What does the Orange Book list for IMODIUM A-D suppliers?
Answer: The FDA’s Orange Book is not a supplier database; it lists approved drug products and patents/ exclusivities tied to an NDA. Supplier sites and contract manufacturing relationships are not consistently captured at the product level.
What does “Orange Book status” tell you for supplier mapping?
Answer: It helps anchor the NDA number and the exact formulation entry, which is the prerequisite to linking to label manufacturing information and patent-controlled product versions.
How do contract manufacturing and packaging suppliers work for branded OTC drugs?
Answer: For OTC loperamide products, packaging and labeling suppliers are often distinct from bulk tablet/capsule manufacturing sites. Distribution is typically handled through branded supply chains with multiple warehouses rather than a single “supplier.”
Are packaging suppliers the same as manufacturing suppliers?
Answer: No. Packaging lines, bottle/blister conversion, labeling, and distribution are usually handled by different specialized units.
Which companies distribute or trade IMODIUM A-D in the U.S. market?
Answer: Distribution is commonly executed by large pharmaceutical distributors and sometimes by specialty OTC supply chains. The exact list of distributors tied to IMODIUM A-D cannot be compiled from the product name alone without the labeled NDC and specific trade item.
Does distributor choice affect supplier identification?
Answer: Yes. “Supplier” can mean API maker, finished-dose manufacturer, packager, or distributor. Each layer has different candidate companies and different public visibility.
How does supplier mapping differ by geography for IMODIUM A-D?
Answer: Imodium formulations and suppliers can vary by region based on regulatory filings, labeling, and sourcing agreements. U.S. sourcing cannot be assumed to match non-U.S. sourcing.
What changes when the product is marketed under different national labels?
Answer: The manufacturing site, packaging, and sometimes excipient blends can change due to national GMP approvals and local regulatory requirements.
Key Takeaways
- “IMODIUM A-D” alone does not uniquely identify the exact NDA/NDC, dosage form, strength, or label manufacturing configuration needed to name specific API and finished-dose suppliers with precision.
- Supplier mapping for loperamide products requires product-level identifiers (NDA/NDC) to connect the brand to approved manufacturing sites, label details, and Orange Book entries.
- For business decisions, treat “supplier” as a layered term: API maker, finished-dose manufacturer, contract packager, and U.S. distributor can be different entities.
FAQs
- Who manufactures loperamide hydrochloride API used in U.S. anti-diarrheals?
- Which companies make branded OTC loperamide finished dosage forms under contract manufacturing?
- How do you identify the exact IMODIUM A-D NDA/NDC to find its approved suppliers?
- Do blister and bottle SKUs for IMODIUM A-D come from the same manufacturing site?
- What filings connect IMODIUM A-D suppliers to FDA-approved drug product entries?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. Drug Approval Reports / NDA/ANDA Information. FDA.
