Suppliers and packagers for generic pharmaceutical drug: METRONIDAZOLE

METRONIDAZOLE

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
Alembic	METRONIDAZOLE	metronidazole	CAPSULE;ORAL	079065	ANDA	Alembic Pharmaceuticals Limited	46708-435-30	30 CAPSULE in 1 BOTTLE (46708-435-30)	2016-12-09
Alembic	METRONIDAZOLE	metronidazole	CAPSULE;ORAL	079065	ANDA	Alembic Pharmaceuticals Limited	46708-435-31	100 CAPSULE in 1 BOTTLE (46708-435-31)	2016-12-09
Alembic	METRONIDAZOLE	metronidazole	CAPSULE;ORAL	079065	ANDA	Alembic Pharmaceuticals Limited	46708-435-50	50 CAPSULE in 1 BOTTLE (46708-435-50)	2016-12-09

Suppliers and packagers for generic pharmaceutical drug: METRONIDAZOLE

Last updated: May 26, 2026

Metronidazole API and Finished Dose Suppliers (2026): Who Manufactures, Where They Ship, and What to Qualify

Metronidazole is produced at scale as both an API and as finished oral/infusion products. The supplier landscape is dominated by large-scale Indian, Chinese, and European manufacturers plus contract manufacturers that support tablets, capsules, and injectable strengths. The practical diligence focus for sourcing is supply continuity for the intended dosage form, DMF status for the target route, controlled substance and hazardous handling requirements tied to manufacturing, and audit readiness for the intended markets.

Quick supplier map (API vs finished dose)

Supply category	Typical supplier profile	What to verify for your project
Metronidazole API	Large-volume API makers; commonly India, China, select Europe/US	DMF/CEP availability, impurity profile/limit alignment, particle size/spec if relevant, EHS and GMP history, cold-chain not typically required but confirm for formulation needs
Finished metronidazole oral tablets/capsules	Brands and generics; often Indian and global generic groups; contract packing common	Regulatory approvals for your target markets, bioequivalence/label strength coverage, packaging compliance, stability data for your shelf life
Finished metronidazole injection (IV)	Higher QA burden; sterile manufacturing and container closure controls	Sterility assurance process, leachables/extractables, container type compatibility, microbiological specs, batch release cadence

Who supplies metronidazole API today, and which countries dominate?

Metronidazole API is a widely traded commodity-grade API with multiple qualified manufacturers. Country dominance is shaped by cost-efficient chemical synthesis capacity (India and China) plus established European/US GMP supply for regulated markets.

Key supplier archetypes by geography

• India (API and finished dose): High coverage across multiple strengths and dosage forms, strong DMF presence across major filings, frequent outsourcing to contract packers.
• China (API and finished dose): Large chemical capacity, broad export footprint; qualification often hinges on DMF harmonization and recent inspection history.
• Europe/US (select API or finished dose): Smaller pool but higher scrutiny and tighter documentation; used when customers require narrower regulatory alignment.

Which companies sell metronidazole finished tablets, capsules, and IV products?

Finished metronidazole is marketed by brand owners and broad generic portfolios. Supply tends to be fragmented by geography and strength (250 mg/400 mg tablets, 500 mg, and IV formulations depending on market), with contract manufacturing and repackaging common in some regions.

Finished dose diligence checklist

• Dosage form alignment: oral immediate-release vs extended or special formulations (less common for metronidazole).
• Strength coverage: confirm your exact label strength and dosage units (tablets vs capsules vs infusion bag).
• Sterile/aseptic controls for IV: for injection/infusion, ensure sterile manufacturing site and container closure system match your risk profile.
• Quality agreements: technical package (CoA templates, change control terms, out-of-spec notification windows).

What are the most common metronidazole API suppliers used for generic manufacturing?

Generic manufacturing groups frequently source metronidazole API from a small number of recurring large API suppliers that can support multiple customers, repeat supply, and regulatory documentation. The supplier selection usually depends on:

• ability to provide DMF/CEP documentation for the destination market,
• consistent impurity profile and method validation readiness,
• stable lead times for commercial-scale batches.

Qualification workflow in practice

1. Regulatory package review (DMF letter status, site coverage, method and impurity limits).
2. Quality audit and batch record sampling.
3. Analytical method crosswalk (impurities, residual solvents, assay, water/LOD).
4. Stability compatibility check with your finished dose formulation.

How do you choose a metronidazole supplier for FDA, EU, and emerging markets?

Supplier choice is market-specific because regulatory acceptance and dossier alignment differ.

US (FDA) sourcing

• Confirm whether the API is covered by a Drug Master File (DMF) and whether your intended strength/dosage form relies on the DMF reference.
• Many generics rely on established DMF-backed API sources that are already used in approved ANDAs.

EU sourcing

• Look for CEP-backed positions where available, or equivalent documentation acceptable to the local competent authority and your QP batch release needs.
• EU batch release and QMS expectations are typically more stringent around change control and validated methods.

Emerging markets

• Practical constraints often shift to documentation completeness, audit turnaround time, and reliability of re-supply rather than purely dossier provenance.

Which metronidazole suppliers are most likely to support contract manufacturing and bulk supply?

Contract manufacturing usually maps to:

• API makers that also support toll conversion or direct supply,
• finished dose CMOs that can execute scale-up, fill-finish for IV, and packaging for multiple label configurations.

Where supply contracts typically break

• IV sterile fill-finish capacity and stability commitments.
• Batch release timelines when regulatory documentation is not aligned to customer submissions.
• Change control friction when the supplier shifts impurity targets or manufacturing routes.

What documentation should metronidazole suppliers provide for regulatory filings?

Minimum documentation families in practice:

• DMF (if referenced) or equivalent API regulatory support package
• CoA templates covering assay, impurities, residual solvents, and water content
• GMP certificate for relevant site and product category
• Stability data supporting requested shelf life
• Specification sheet and analytical method details
• Change control commitments (notification windows, evaluation approach)

What risks exist when sourcing metronidazole from API suppliers (quality, supply, and compliance)?

For metronidazole, the dominant sourcing risks are typical for generic APIs:

• Impurity drift tied to raw material sourcing changes or route changes
• Method mismatch between supplier specs and finished dose acceptance criteria
• Inspection findings that trigger heightened review or requalification
• Supply interruptions due to capacity shifts at high-volume API plants

Risk controls that work

• Multi-sourcing with at least two qualified API sites.
• Tight incoming testing aligned to your release specs.
• Contractual change notification and comparability requirements.

What is the supplier best-practice approach for metronidazole injection (IV)?

IV adds a distinct layer beyond API quality:

• sterile manufacturing controls,
• container closure and infusion compatibility,
• leachables/extractables evaluation,
• microbiological and bioburden specifications.

IV-specific audit points

• sterilization method validation approach (as applicable),
• filter integrity testing process,
• environmental monitoring and aseptic behavior records,
• batch record traceability to materials and container lot numbers.

Metronidazole vs competitor antibiotics: How supplier availability compares

Metronidazole has broad supply coverage relative to many specialty antibiotics due to its established manufacturing base and long market history.

Practical procurement implication

• For commercial supply, metronidazole typically has fewer shortage events than newer specialty anti-infectives, though localized shortages can occur based on sterile capacity or specific strength discontinuations in some regions.

Key Takeaways

• Metronidazole sourcing is a mature supply chain with multiple qualified API suppliers and broad finished-dose availability.
• Supplier selection should center on DMF/CEP alignment for your target markets, stable impurity profiles, and audit readiness.
• IV products require stricter qualification around sterile fill-finish, container closure system, and leachables/extractables.

FAQs

1. Do DMFs exist for metronidazole API in the US, and how does that affect ANDA submissions?
2. Which metronidazole API suppliers are suitable for both oral tablets and IV formulations?
3. What quality attributes of metronidazole API most frequently drive finished-dose out-of-spec events?
4. How do container closure choices affect metronidazole injection compatibility and leachables?
5. What contract manufacturing model is most common for metronidazole finished dose supply in generics: CMOs vs toll packers?

References

1. FDA. “Drug Master Files (DMF).” U.S. Food and Drug Administration.
2. EMA. “CEP: Certificates of Suitability.” European Medicines Agency.
3. FDA. “ANDA Submission Policy and Procedures.” U.S. Food and Drug Administration.