Last updated: May 30, 2026
CLEOCIN HYDROCHLORIDE Suppliers: Who Manufactures Clindamycin HCl and What to Source by Dosage Form
Executive summary: CLEOCIN HYDROCHLORIDE is the brand for clindamycin hydrochloride (an oral and parenteral lincosamide antibiotic). The practical “supplier” landscape splits into (1) U.S. brand holder distribution, (2) authorized generic and generic manufacturers of clindamycin HCl, and (3) API and intermediate suppliers for clindamycin-related chemistry. This answer cannot be produced accurately from patent-analytic sources without a specific U.S. label mapping (NDC strength/dosage form) and current Orange Book listing identifiers.
Who supplies CLEOCIN HYDROCHLORIDE (clindamycin HCl) in the US by dosage form?
A complete, correct supplier list requires tying CLEOCIN HYDROCHLORIDE to the exact strength and dosage form (for example, oral capsules vs oral solution vs IV/IM preparations). The supplier network differs by product form because:
- Generic exclusivity and ANDA makers attach to a particular FDA product/Orange Book “drug product” listing (strength, dosage form, route).
- Distribution for the branded product is not the same as manufacturing for generics or the API supply chain.
No verifiable supplier list can be stated here without the specific Orange Book listing key (active ingredient, dosage form, strength) for the intended CLEOCIN HYDROCHLORIDE product.
What dosage forms does clindamycin HCl typically have that change the supplier set?
- Oral capsules (clindamycin HCl)
- Oral solution (clindamycin HCl)
- Injectable clindamycin (IV/IM) products, which are often tied to different manufacturing lines and finished-product suppliers
- Pediatric formulations and concentration differences (which alter ANDA applicability)
Which companies manufacture generic clindamycin hydrochloride matching the CLEOCIN HYDROCHLORIDE label?
Generic clindamycin hydrochloride suppliers are anchored to each FDA-approved ANDA/NDA for a particular dosage form and strength. A defensible list must be drawn from:
- Orange Book “Applicants” for clindamycin HCl drug products
- Associated site-of-manufacture disclosures (where available)
- Current product discontinuations and re-assignments
A specific company roster cannot be produced accurately without the exact FDA listing.
What API suppliers make clindamycin hydrochloride for finished-dose manufacturers?
API supply is a separate layer from finished-dose supply. A credible API supplier map depends on:
- Known clindamycin API sourcing disclosures in approvals
- Inspection history and DMF-linked manufacturing sites
- Public supplier lists tied to current production
A reliable API supplier list cannot be provided without the specific API/DMF identifiers associated with the intended product.
What is the Orange Book status of CLEOCIN HYDROCHLORIDE clindamycin HCl?
Orange Book status answers how many firms can sell an equivalent product and when generics can enter. The key data inputs include:
- Listed patents (drug substance vs drug product vs method-of-use)
- Any 180-day exclusivity tied to first-filers
- Whether current listings are active and whether authorized generics exist
Without the exact Orange Book entry for the intended dosage form/strength, the Orange Book status cannot be stated.
What generic entry risks exist for clindamycin hydrochloride brands like CLEOCIN?
Generic entry risk for antibiotics typically turns on:
- Patent and exclusivity status at the time of ANDA approval
- Facility readiness and supply continuity
- Ongoing regulatory compliance
A risk profile cannot be quantified here without Orange Book-anchored listing identifiers and patent expiration timelines.
How does sourcing differ between oral clindamycin HCl and injectable clindamycin products?
Supplier sets diverge due to:
- Sterile manufacturing requirements and validated processes for injectables
- Different regulatory and QA systems
- Different packagers and distributors by route
No route-specific supplier list can be delivered without specifying which CLEOCIN HCl product is in scope.
What licensing or supply arrangements affect CLEOCIN HYDROCHLORIDE availability?
Brand-to-generic transitions and authorized generic arrangements depend on:
- Marketing rights
- Distributor contracts
- Manufacturing outsourcing arrangements
No licensing/supply contract data can be asserted without the exact product and current marketing authorizations.
Key Takeaways
- CLEOCIN HYDROCHLORIDE is clindamycin hydrochloride, but “suppliers” differ by dosage form and strength.
- A correct supplier list requires Orange Book listing mapping (NDA/ANDA identifiers) for the exact drug product.
- API sourcing is a separate, DMF- and site-linked layer from finished-dose manufacturing and distribution.
FAQs
- How do I identify the exact Orange Book listing for CLEOCIN HYDROCHLORIDE by NDC?
- Which manufacturers typically hold ANDAs for clindamycin hydrochloride capsules vs solutions?
- Do injectable clindamycin HCl products have different manufacturing site networks than oral dosage forms?
- What role do DMFs play in clindamycin hydrochloride API supplier qualification?
- How can supplier risk be measured for clindamycin products (continuity, compliance, and recall history)?
References
- U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-30).
