Last updated: April 25, 2026
Who Supplies Nisoldipine to the Market?
Nisoldipine is a calcium channel blocker (dihydropyridine) marketed in the U.S. as an oral extended-release product under the brand SULAR (nisoldipine). Supply into the market comes through (1) original-brand manufacturing and (2) generic manufacturers with FDA-approved ANDA products that source drug substance (API) from qualified API suppliers and formulate/finish the finished dosage form at their own sites or contract manufacturers.
Which companies supply nisoldipine products (drug product suppliers/marketers)?
U.S. branded source
- SULAR (nisoldipine extended release)
- Labeling is typically tied to the brand authorization holder and the branded manufacturing chain used to supply FDA-labeled product.
Generic ANDA landscape (who supplies product)
The U.S. market for nisoldipine extended-release is served by multiple generic ANDAs. Each ANDA applicant (often multiple) is a “supplier” of the finished dosage form under the ANDA, even if the API is sourced from another company.
What matters for business sourcing: finished-dose supply is controlled by the ANDA holder and the specific manufacturing sites listed in the application and on FDA labeling, while API supply is controlled by the API manufacturer(s) qualified for that ANDA.
Which API suppliers manufacture nisoldipine (drug substance suppliers)?
Nisoldipine API sourcing is handled through qualified API manufacturers that provide the active ingredient to ANDA formulators. In practice, ANDA holders either:
- buy API from a dedicated contract API manufacturer, or
- own and operate API manufacturing, but still manage release testing and quality agreements.
What supply chain profiles are used for nisoldipine extended release tablets?
Nisoldipine is supplied as a controlled release/extended-release oral dosage form. That drives supplier selection toward firms with proven capability in:
- film coating and polymer-based extended release manufacturing,
- in-process controls for dissolution and content uniformity,
- packaging and stability programs aligned to FDA requirements.
How to map nisoldipine suppliers for procurement (decision-grade view)
A procurement-ready map splits suppliers into two layers:
1) Finished dosage form suppliers
- ANDA applicant (labeler/marketer)
- Manufacturing sites for drug product (tablet pressing, coating, extended-release process, packaging)
2) Nisoldipine API suppliers
- API manufacturer(s) listed for the ANDA supply chain
- Release testing responsibility and quality agreement terms
Supplier categories by role in the nisoldipine chain
| Role |
What the supplier controls |
Procurement artifact to request |
| Brand/ANDA labeler (drug product) |
Finished-dose availability, labeling, lot release logistics |
NDA/ANDA labeler details, lot traceability, certificate of analysis (COA) |
| Contract manufacturer (drug product) |
Tablet/coating/extended-release manufacture |
Site manufacturing authorization, batch record summary, dissolution specs |
| API manufacturer |
Nisoldipine active ingredient production and QC release |
Drug substance COA, API specs, impurity profile summary |
| Quality/release network |
Release testing and stability commitment |
Quality agreement, out-of-spec handling SOP summary |
Key technical checkpoints suppliers must satisfy (nisoldipine ER)
Procurement and regulatory risk is concentrated in dissolution performance and impurity control. For nisoldipine ER, suppliers are expected to consistently meet:
- Assay and content uniformity for each batch
- Dissolution profile consistent with extended-release performance targets (commonly assessed across timepoints)
- Impurity specifications aligned with ANDA acceptance criteria (impurity list and limits vary by ANDA)
- Stability program results supporting shelf-life and storage conditions
Key Takeaways
- Nisoldipine supply in the U.S. is provided through branded and generic ANDA finished-dose suppliers, each tied to specific manufacturing sites and quality systems.
- API suppliers are determined by the ANDA supply chain; drug product formulators source from qualified API manufacturers or internal API production.
- For procurement, map suppliers by (1) ANDA labeler/marketer and (2) drug product manufacturing site, then trace to the API manufacturer supporting that ANDA.
- The main technical supplier risk for nisoldipine ER is extended-release dissolution performance and impurity control.
FAQs
1) Is nisoldipine sold only as a branded product?
No. The U.S. market includes branded SULAR and generic extended-release tablets under ANDAs.
2) Who is the actual “supplier” when buying nisoldipine tablets?
For procurement, the seller is the product labeler/marketer and the drug product manufacturer tied to the ANDA lot you receive.
3) Are API suppliers the same across all generic nisoldipine products?
No. Different ANDAs can qualify different API manufacturing sites and impurity profiles.
4) What technical parameters drive supplier qualification for nisoldipine ER?
Dissolution performance for extended release, assay/content uniformity, and impurity control are the primary batch-to-batch checkpoints.
5) What documentation should a nisoldipine supplier provide for quality traceability?
A lot-specific COA, manufacturing site/batch traceability, and quality agreement terms covering release testing and deviations.
References
[1] FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Nisoldipine extended release. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. FDA. Drug Approval Reports. https://www.accessdata.fda.gov/scripts/cder/daf/daftar/
[3] DailyMed. SULAR (nisoldipine) labeling. https://dailymed.nlm.nih.gov/
