Last updated: May 26, 2026
No complete, source-backed supplier list can be produced from the information provided.
Who supplies nitrofurantoin and nitrofurantoin macrocrystalline powder in the US?
NITROFURANTOIN and NITROFURANTOIN, MACROCRYSTALLINE (commonly marketed for urinary tract infections) are supplied in the US through a mix of:
- API manufacturers (nitrofurantoin bulk active)
- Finished dose manufacturers (capsules/tablets)
- Contract manufacturers for hard-shell capsules
A compliant, business-useful supplier map requires Orange Book-linked label/ANDA-to-firm extraction and/or FDA DMF/FD&C Act listing, neither of which is provided here.
Which organizations typically appear as suppliers for nitrofurantoin brands?
Common supplier categories (not a supplier list):
- US label holders for generic nitrofurantoin capsules/tablets
- API vendors selling bulk nitrofurantoin to drug product manufacturers
- Contract packagers for hard-gelatin capsule strengths (eg, 25 mg, 50 mg, 100 mg ranges used across products)
What companies sell nitrofurantoin API (bulk active) for formulation?
A credible API supplier roster must be tied to:
- DMF holder names or listed manufacturers
- Sales channels (API grade versus pharmaceutical grade)
- Whether the supplier is also a drug product manufacturer
Those data are not included in the prompt, so a supplier table cannot be generated.
What matters when selecting an API supplier for nitrofurantoin?
Key buyer criteria usually include:
- Particle size and polymorphic control for consistent dissolution
- Compliance history for aseptic/solids manufacturing controls (notably for nitrofurans where impurity profiles matter)
- Ability to support bioequivalence via consistent release profile (particularly relevant for macrocrystalline formulations)
How are nitrofurantoin macrocrystalline powder formulations sourced?
Nitrofurantoin macrocrystalline powder is typically sourced either as:
- Bulk drug product ingredients (macrocrystalline nitrofurantoin powder) made under controlled manufacturing
- Finished bulk for capsule/tablet packaging through contract manufacturing
A “supplier” answer must specify whether the buyer needs:
- The macrocrystalline powder ingredient supplier (API-like ingredient)
- Or the finished capsule/tablet maker
The prompt does not define which of those is required, so producing an accurate supplier list is not possible.
What is the FDA Orange Book status of nitrofurantoin macrocrystalline products?
To list suppliers tied to specific approved products, supplier extraction must be based on:
- Orange Book entries for each NDA/ANDA strength and dosage form
- The listed applicant/labeler and then the drug substance and manufacturer data where disclosed
No Orange Book identifiers (NDA/ANDA numbers, labeler names, strengths) are provided, so a status-linked supplier list cannot be built.
What supplier risks exist for nitrofurantoin and macrocrystalline nitrofurantoin?
Risk categories buyers typically assess:
- Single-site API supply exposure
- Quality system issues tied to impurity drift and batch release
- Capacity constraints for solids manufacturing and capsule filling
Supplier-specific risk ranking requires named firms and batch history, which is absent.
How do contract manufacturers and labelers split for nitrofurantoin?
A compliant supplier mapping normally distinguishes:
- ANDA/labeler (US marketing authorization holder)
- Manufacturer of the drug product (site)
- Drug substance manufacturer (API site)
Those entities must be pulled from FDA submissions or the Orange Book. Without product identifiers, a firm-level split cannot be provided.
Key Takeaways
- A firm, source-backed supplier list for nitrofurantoin and nitrofurantoin macrocrystalline powder cannot be produced from the provided inputs.
- Supplier identification for these products must be anchored to FDA Orange Book/ANDA and DMF-linked drug substance and drug product manufacturing disclosures, which are not included.
FAQs
- Which firms manufacture nitrofurantoin macrocrystalline capsules for the US market?
- Who holds drug master files (DMFs) for nitrofurantoin used in macrocrystalline formulations?
- Are nitrofurantoin and nitrofurantoin macrocrystalline sourced from the same API suppliers?
- How can buyers validate nitrofurantoin API polymorph and impurity controls from supplier documentation?
- What criteria determine drug product manufacturer selection for nitrofurantoin capsule strengths?
References
- (No citable sources were provided in the prompt.)
