Suppliers and packagers for generic pharmaceutical drug: QUINIDINE SULFATE

QUINIDINE SULFATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-512-01	100 TABLET in 1 BOTTLE (42806-512-01)	2021-12-15
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-512-30	30 TABLET in 1 BOTTLE (42806-512-30)	2021-12-15
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-513-01	100 TABLET in 1 BOTTLE (42806-513-01)	2021-12-15
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-513-30	30 TABLET in 1 BOTTLE (42806-513-30)	2021-12-15

Quinidine Sulfate API and Finished-Drug Suppliers: Who Provides Supply, What Products They Make, and Where Risks Concentrate

Last updated: May 23, 2026

Executive summary: Quinidine sulfate supply is typically split across (1) API producers that make quinidine sulfate (or quinine-derived intermediates that convert to quinidine sulfate) and (2) finished-dose manufacturers that sell quinidine sulfate tablets under FDA-approved labeling. On the US market, the key commercial supply chain and contract manufacturing risk is concentrated in a small set of NDA/ANDA holders and specialty generics that source USP-grade quinidine sulfate API and fill-tablet lots through controlled potency and content-uniformity processes.

1) API and intermediate sourcing for quinidine sulfate: where it usually comes from Quinidine sulfate is the quinidine salt form of the naturally derived cinchona alkaloid quinidine (from cinchona bark supply chains) and is normally produced through purification of quinidine base and salt formation to the sulfate. That structure drives supplier geography and capability toward botanically derived alkaloid chemistry, solid-state salt formation, and cGMP controls for alkaloid impurity profiles.

Typical supplier categories

• API manufacturers (cinchona alkaloid capability): Produce “Quinidine Sulfate” API compliant with pharmacopeial specs (often USP/EP) and support DMF filings where available.
• Specialty contract manufacturers for tablets: Purchase API and perform granulation, blending, compression, coating, and QA release under cGMP for generics.
• Finished-dose wholesalers/distributors: Market through NDC channels but do not always manufacture.

What suppliers make quinidine sulfate API for tablets and generics?

Featured snippet answer: Quinidine sulfate API is supplied by a limited number of specialty API makers with alkaloid purification and controlled salt formation capabilities; finished-dose tablets are then produced by FDA-registered generic and branded manufacturers using that API.

Common API sourcing pattern in the quinidine sulfate supply chain

• API buyers (tablet makers) qualify suppliers through incoming COA review plus identity/potency testing.
• Salt form control is central because quinidine sulfate properties (solubility, stability, hydration behavior) can affect dissolution and potency uniformity.
• Impurity control is also central due to quinine/quinidine isomer fractions and related alkaloid impurities that can change assay.

What to look for when mapping API suppliers

• DMF/EDMF holders for quinidine sulfate API (US, and often EU via EDMF)
• Pharmacopeial compliance claims (USP/EP) in supplier documentation
• Batch traceability for alkaloid-derived raw materials
• Sterility is not a factor (quinidine sulfate is an oral solid), so qualification focus is potency, dissolution, microbial limits, and solid-state performance

Which companies sell quinidine sulfate tablets in the US?

Featured snippet answer: US quinidine sulfate availability is driven by prescription-oriented manufacturers that hold FDA-approved ANDAs (generics) and sell tablets under NDCs; the dominant commercial risk is supply continuity in a narrow number of qualified manufacturers.

How to identify the “active” suppliers (commercially relevant)

• Match NDCs for quinidine sulfate tablets to:
  • the labeler on the carton/NDC directory
  • the application holder tied to the product (ANDA/NDA holder)
• Confirm whether the labeler is the manufacturer of record or a marketing distributor.

Why tablets matter for supplier selection

• Quinidine sulfate tablet manufacturing requires:
  • consistent granulation and blend uniformity for narrow potency targets
  • stable dissolution profile to meet dissolution specs
  • content-uniformity controls that can expose API variability

What is the Orange Book status of quinidine sulfate (ANDAs, exclusivity, listed patents)?

Featured snippet answer: Quinidine sulfate tablets are generally older, small-market products. Orange Book entries (active, expired, and any remaining listed patents or exclusivity) determine whether Paragraph IV challenges are feasible and who can launch without risking patent litigation.

Typical outcomes in older generic salt products

• Most protection usually comes from expiring patents and any remaining formulation or method-of-use listings.
• If Orange Book listings are absent or expired for specific strengths/forms, competition often becomes supplier-and-manufacturing driven rather than patent driven.

When do quinidine sulfate generics lose exclusivity, and what drives launch timing?

Featured snippet answer: Launch timing for quinidine sulfate depends on the expiration of any Orange Book-listed patents tied to the specific NDC strength and dosage form plus any exclusivity periods associated with the application history, if still applicable.

Timing drivers for tablet generics

• Patent expiration (composition, formulation, polymorph/process, or method-of-use if ever listed)
• Exclusivity blocks (if any remain for specific filings)
• FDA approval processing and facility readiness

How many patents protect quinidine sulfate tablets, and which ones matter for litigation risk?

Featured snippet answer: Patent counts are usually low for older quinidine sulfate presentations; the practical litigation risk is concentrated if any still-listed Orange Book patents cover:

• specific formulations (excipients, coating system)
• manufacturing processes (granulation/compaction parameters)
• bioavailability or dissolution targets
• method-of-use claims (less common for classic antiarrhythmic uses but possible)

Patent estate mapping approach (what matters)

• Identify the listed patents for each NDC strength
• Extract:
  • patent numbers
  • claims categories (composition vs formulation vs method)
  • assignees and expected ownership changes
• Tie each patent to the manufacturer’s ANDA/NDA.

What generic entry risks exist for quinidine sulfate (Paragraph IV, supply interruption, FDA quality holds)?

Featured snippet answer: The main entry risk is often operational rather than patent-only: the product’s value density is low and there are fewer qualified manufacturing slots, so supply interruptions can follow API shortages, equipment downtime, or quality remediation at a single site.

Risk categories that affect market continuity

• API supply disruption from upstream alkaloid sourcing or API facility downtime
• cGMP compliance events that lead to hold or withdrawal
• potency/dissolution drift due to variability in incoming API lots
• stability requalification needs after process changes

What formulations are protected or relevant for quinidine sulfate tablets?

Featured snippet answer: If any formulation patents exist, they typically cover tablet composition and performance attributes that maintain dissolution and content uniformity, including:

• excipient system
• manufacturing process conditions that control particle size and blend uniformity
• coatings or release modifiers if used

What tablet characteristics drive supplier suitability

• Dissolution profile alignment to label specification
• Content uniformity under GMP
• Trace impurity profile compatibility with pharmacopeial limits

Biosimilar risk for quinidine sulfate: does it apply?

Featured snippet answer: No. Quinidine sulfate is a small-molecule oral drug; biosimilar pathways do not apply.

Manufacturing/IP barriers for new quinidine sulfate tablet entrants

Featured snippet answer: The barriers are primarily quality-system and process control constraints, not biologics IP. A new entrant must demonstrate:

• reliable API procurement and incoming testing
• repeatable tablet manufacturing that meets dissolution and content uniformity
• stable product performance across GMP changes

Practical barriers

• Supplier qualification cycles for API
• Stability and dissolution bridging for new tablet process changes
• Risk-based validation of mixing and granulation for alkaloid salts

Key Takeaways

• Quinidine sulfate supply is dominated by a small number of qualified sources because the drug depends on specialized alkaloid-derived API supply and robust tablet process controls.
• For business planning, supplier mapping should prioritize (1) NDC labeler/manufacturer of record and (2) API source continuity and DMF-linked manufacturing sites.
• Market entry and continuity risk are more likely operational (API availability and tablet manufacturing quality) than patent-driven for many quinidine sulfate presentations, given typical older-product protection profiles.

FAQs

1. How do I identify the actual manufacturer for quinidine sulfate tablets behind an NDC labeler name?
   Use the FDA product listing to trace NDC labeler to the ANDA/NDA holder and then cross-check the manufacturing site listed for the product.

2. What API quality attributes are most critical for quinidine sulfate tablet consistency?
   Potency/assay, content uniformity risk from API lot variability, dissolution performance drivers, and impurity profile adherence to pharmacopeial limits.

3. What typically causes quinidine sulfate shortages in the supply chain?
   Upstream alkaloid/API supply disruption, manufacturing downtime, or quality remediation that pauses release at a key tablet site.

4. Are there any dosage forms of quinidine sulfate besides tablets that change supplier mapping?
   Yes, if injectable or alternative solid dosage forms exist, they shift manufacturing requirements, sterility controls (for injectables), and different qualified facilities.

5. Can switching API suppliers force FDA re-qualification for quinidine sulfate products?
   It can, depending on whether the change is within approved comparability ranges and whether the ANDA’s changes require prior approval supplements.

References

No sources were used in this response.