Suppliers and packagers for FLAGYL

FLAGYL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	FLAGYL	metronidazole	CAPSULE;ORAL	020334	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1942-34	100 BLISTER PACK in 1 CARTON (0025-1942-34) / 1 CAPSULE in 1 BLISTER PACK	1995-05-03

FLAGYL (metronidazole): Who supplies it, what the Orange Book/labels show, and where API and finished-dose sourcing concentrates

Last updated: May 29, 2026

FLAGYL is metronidazole, a widely manufactured nitroimidazole antibiotic. U.S. supply is dominated by multiple ANDA-capable generic manufacturers and contract manufacturing for finished-dose tablets and IV products, with API sourcing spread across established fine-chemical producers.

Which companies supply FLAGYL (metronidazole) tablets and IV in the US?

Short answer: Expect multi-supplier coverage for metronidazole across the tablet and IV presentations, with the U.S. market primarily served by generic manufacturers under ANDAs and authorized distributors rather than a single exclusive finished-dose supplier.

Finished-dose suppliers (tablets, oral suspensions, IV solutions): what to expect

Key practical sourcing reality for FLAGYL is that “FLAGYL” is a branded label name; the underlying drug is metronidazole, which is off-patent. That typically yields:

• Broad ANDA generic availability for tablets (and, depending on NDC, oral dosage forms)
• Multiple manufacturers for metronidazole IV infusion solution (NDC-specific)
• Frequent warehouse and distributor rotation depending on FDA inspection status, production schedules, and short-term supply constraints

What drives supplier selection for procurement

Commercial buyers typically validate:

• NDC-specific manufacturer and labeler of record (not the brand name)
• FDA facility inspection history and compliance standing for the labeled product
• Batch release and availability lead times for tablets vs IV (IV is generally more constrained)
• Contract manufacturing changes that can rotate “who supplies” a given NDC over time

What API suppliers make metronidazole used to produce FLAGYL?

Short answer: Metronidazole API supply is generally handled by multiple global fine-chemical manufacturers, with downstream finished-dose makers importing or buying API via brokers and CMOs.

API supply chain structure for metronidazole

For commodity antibiotics like metronidazole:

• API is produced in specialty chemical sites with nitro-reduction and nitroimidazole synthesis capabilities
• Finished-dose firms buy API and then package tablets or compound IV solutions under their own quality systems
• Procurement often sources API through large distributors, not directly from the API producer

Common procurement pattern

• Finished-dose manufacturers use qualified API suppliers and maintain change-control when shifting API lots or sites
• Buyers that need continuity typically qualify multiple finished-dose NDCs, not just one vendor

How does the Orange Book status affect “who supplies FLAGYL”?

Short answer: With metronidazole’s brand exclusivity long expired, the Orange Book typically shows no blocking composition claims for new generic entrants on most markets, supporting multiple suppliers.

What Orange Book listings imply for supplier multiplicity

When a drug is off-patent:

• ANDA holders proliferate
• NDC-level supply becomes the operational bottleneck
• Supplier risk shifts from patent barriers to manufacturing capacity and inspection timing

Which FDA-approved products map to FLAGYL’s metronidazole presentations?

Short answer: FLAGYL corresponds to metronidazole products across oral and IV dosing forms, with each NDC tied to a labeled manufacturer.

NDC-level mapping: procurement-critical

Procurement should treat “FLAGYL” as a brand reference point and then:

• Identify the exact NDC(s) needed for each formulation and strength
• Confirm the labeled manufacturer for each NDC for the active U.S. listing
• Track substitution risk if a particular NDC rotates manufacturing sites

When do supplier shortages happen for metronidazole (FLAGYL), and why?

Short answer: Shortages usually track manufacturing disruptions at one or a few API or sterile-filling sites, IV-specific line outages, or QC release backlogs, not patent timing.

Typical shortage drivers

• Sterile manufacturing downtime (for IV products)
• Sterilization capacity constraints for infusion solutions
• QC release delays caused by analytical method deviations
• Raw material supply volatility at API producers

How many manufacturers supply metronidazole in the US?

Short answer: The number is “many” for tablets and at least several for IV, driven by generic ANDA competition and NDC-level replication.

What “many suppliers” means operationally

• Procurement can usually find alternatives within the same presentation and strength
• Substitution can be done by switching NDCs or using therapeutically equivalent generics if labeling permits
• IV sourcing is the most likely to require a multi-vendor plan

What are the biggest IP and regulatory constraints on new metronidazole suppliers?

Short answer: For metronidazole, regulatory and CMC barriers matter more than patent barriers.

Regulatory constraints

• ANDA bioequivalence requirements for oral solids (waivers may apply depending on reference listing)
• Sterile manufacturing validation and inspection readiness for IV
• Labeling and compendial equivalence

IP constraints

• Patent-based exclusivity is typically not the gating factor for most metronidazole supply expansion
• The practical constraint is the manufacturer’s ability to scale and sustain quality systems

Compare FLAGYL metronidazole tablet suppliers vs IV suppliers: where supply risk concentrates?

Short answer: Tablet supply is usually more resilient due to more manufacturing slots. IV supply concentrates risk around fewer sterile facilities.

Tablets (oral): typical sourcing risk profile

• More stable because oral solid manufacturing is less facility-constrained
• Substitution across multiple generics is easier operationally

IV (sterile): typical sourcing risk profile

• Fewer qualified sterile fillers and higher regulatory/CMC burden
• More sensitive to staffing, line downtime, and sterility assurance testing

Key Takeaways

• FLAGYL is metronidazole; U.S. supply is served by multiple generic manufacturers under ANDAs, not a single branded supplier network.
• Supplier identity is best tracked by NDC and labeled manufacturer of record, not by “FLAGYL” branding.
• API supply is globally distributed; finished-dose manufacturers rely on qualified API sourcing and can rotate API sites under change control.
• For procurement and continuity planning, the operational bottleneck is often IV sterile manufacturing capacity rather than patent or exclusivity barriers.

FAQs

1. Which NDCs correspond to metronidazole/FLAGYL tablets in the US?
   NDCs are presentation- and strength-specific; identify the required strength and use the NDC labeler/manufacturer of record for sourcing.

2. Is metronidazole FLAGYL available as generics under ANDA?
   Yes. Most market supply comes from ANDA-labeled generic equivalents of metronidazole.

3. What product substitutions are possible if a specific FLAGYL NDC is out of stock?
   Switch to an equivalent NDC for the same strength and dosage form, validating label instructions and logistics with the wholesaler and hospital formulary.

4. Why do shortages more often affect IV metronidazole than tablets?
   Sterile manufacturing and QC release constraints create tighter capacity windows for IV.

5. Do patents restrict new entrants for metronidazole supply?
   For most metronidazole uses and formulations, patent barriers are generally not the primary driver of supplier availability; CMC and regulatory readiness are the key constraints.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book).
2. FDA. Drug Shortages. (Metronidazole/FLAGYL-related entries when available).