Last updated: April 23, 2026
Who Supplies Dicyclomine Hydrochloride (API and Finished Dosage Forms)?
Dicyclomine hydrochloride is an established, off-patent small-molecule antispasmodic. Suppliers exist across two tiers: (1) active pharmaceutical ingredient (API) manufacturers and (2) finished dosage form (FDF) producers and branded/generic marketers. The supplier universe depends on whether you need API, tablets/capsules, or injectable presentations.
What are the main supplier categories?
| Category |
What you source |
Typical buyer use |
| API manufacturers |
Dicyclomine hydrochloride (raw API) |
Generic manufacturing, compounding, contract manufacturing |
| FDF manufacturers |
Tablets/capsules and (where applicable) injectable forms |
Direct formulation procurement or distribution |
| Repackers / distributors |
API or FDF with distribution, relabeling, and supply chain services |
Regional procurement, compliance warehousing |
Which Companies Commonly Supply Dicyclomine Hydrochloride?
The supplier set is best captured via public procurement channels, drug listing databases, and regulatory reference points for generic competition. Below are company groups that repeatedly appear in association with dicyclomine products in regulated markets, either as marketers of generics or as manufacturers supplying those products.
API supply: who manufactures the active?
A complete, current API manufacturer roster requires live database pulls (customs/entry data or controlled API directories). With static public data alone, only a partial supplier list can be asserted without risking factual error.
Finished dosage forms: who sells generics?
Public drug product listings show multiple generic manufacturers and marketers for dicyclomine hydrochloride in different strengths and dosage forms. The most reliable public anchors are FDA’s Orange Book listings (US) and comparable regulatory product databases in other jurisdictions.
US marketed generic manufacturers (examples that appear on FDA product listings for dicyclomine hydrochloride products):
- Teva Pharmaceuticals (generic dicyclomine hydrochloride products)
- Mylan / Viatris (generic dicyclomine hydrochloride products)
- Sandoz (generic dicyclomine hydrochloride products)
- Amneal Pharmaceuticals (generic dicyclomine hydrochloride products)
- Dr. Reddy’s Laboratories (generic dicyclomine hydrochloride products)
- Par (generic dicyclomine hydrochloride products)
- Alvogen (generic dicyclomine hydrochloride products)
- Camber Pharmaceuticals (generic dicyclomine hydrochloride products)
These are marketers/manufacturers tied to specific labeled strengths, dosage forms, and application types on the Orange Book. The exact labeled product (tablet vs capsule, mg strength, and whether it is IR/ER) determines which company is the direct product sponsor.
Which Dosage Forms and Strengths Drive Supplier Selection?
Supplier availability changes by presentation. Procurement due diligence should match the presentation precisely.
What common presentations exist?
| Presentation |
Typical strengths seen in generic markets |
Procurement impact |
| Immediate-release tablets/capsules |
Common mg strengths vary by market and sponsor |
Many generic options |
| Injectable (where marketed) |
Less common than oral |
Fewer suppliers, stricter QA and supply continuity |
Because supplier lists are presentation-specific, your sourcing plan must map to the exact presentation and strength you will purchase or manufacture.
How to Use Regulatory Listings to Identify the Real Supplier
What is the fastest way to identify who can legally sell it in the US?
Use FDA’s Orange Book to list all approved product sponsors for dicyclomine hydrochloride, then match:
- Application type (ANDA)
- Listed manufacturer(s)
- Submission history and exclusivity status (if any, even though the molecule is widely off-patent)
- Product strength and dosage form
FDA Orange Book is the most direct way to convert “there are suppliers” into a legally documented set of sponsors per product presentation. Source: FDA Orange Book search.
Key Procurement Implications
What matters when selecting a supplier for dicyclomine hydrochloride?
| Criterion |
Why it matters |
What to check |
| Presentation match |
Supplier list differs by tablet strength and dosage form |
Exact labeled strength and IR/ER designation |
| Quality system readiness |
Off-patent products still require GMP and lot-to-lot control |
GMP status and CoA/Lot testing record |
| Supply continuity |
Generic markets can re-allocate manufacturing quickly |
Multi-lot availability, lead times, and alternate plan |
| Regulatory history |
Changes in manufacturing site(s) happen |
Orange Book sponsor/manufacturer mapping and updates |
Key Takeaways
- Dicyclomine hydrochloride has a wide supplier footprint, but the “supplier” depends on whether you need API or finished dosage.
- For US finished dosage procurement, FDA Orange Book is the operational source to identify the actual approved product sponsors by strength and dosage form.
- Generic suppliers commonly seen across Orange Book listings include Teva, Viatris/Mylan, Sandoz, Amneal, Dr. Reddy’s, Par, Alvogen, and Camber, with the exact sponsor varying by product strength and formulation.
FAQs
1) Are there many manufacturers of dicyclomine hydrochloride tablets in the US?
Yes. Multiple ANDA sponsors list dicyclomine hydrochloride products across different strengths and dosage forms on the FDA Orange Book.
2) Does the supplier list change by dosage form and strength?
Yes. Orange Book sponsors vary by presentation, so a supplier that appears for one strength or tablet type may not be the sponsor for another.
3) Is dicyclomine hydrochloride still patent-restricted in sourcing?
The molecule is widely generically available in regulated markets, so supply is typically dominated by generic manufacturing capacity rather than patent-protected exclusivity.
4) What is the best public tool to identify finished dosage sponsors?
The FDA Orange Book listing for dicyclomine hydrochloride.
5) Can I identify API manufacturers from public sources alone?
Only partially without live controlled-directories or procurement data. For FDF, Orange Book is the definitive source; for API, your best practice is to map confirmed GMP API production through validated supplier documentation and regulatory/QMS evidence.
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
