Suppliers and packagers for generic pharmaceutical drug: PYRAZINAMIDE

PYRAZINAMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-21	60 TABLET in 1 CONTAINER (0054-0812-21)	2024-08-30
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-22	90 TABLET in 1 CONTAINER (0054-0812-22)	2024-08-30
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-25	100 TABLET in 1 CONTAINER (0054-0812-25)	2024-08-30
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-29	500 TABLET in 1 CONTAINER (0054-0812-29)	2024-08-30

Suppliers and packagers for generic pharmaceutical drug: PYRAZINAMIDE

Last updated: April 25, 2026

Who Supplies Pyrazinamide for Pharmaceutical and API Use?

Pyrazinamide is a commodity-style active pharmaceutical ingredient (API) used primarily in tuberculosis (TB) therapy. Supply tends to be handled by large Asian API manufacturers plus specialty chemical producers and toll manufacturers that can deliver technical-grade material, USP/BP/EP-grade API, or dossier-supported API batches. Below is a procurement-focused map of supplier types and typical sourcing channels used for pyrazinamide.

What supplier categories cover pyrazinamide procurement?

Supplier type	What they sell	Typical procurement route	Common evidence you can require
API manufacturers (commercial)	Pyrazinamide API in bulk (25 kg, 50 kg, often with DMF/CEP where applicable)	Direct purchase or distributor	COA, GMP certificate, traceability, stability protocol, spec sheet
Specialty chemical producers	Pyrazinamide for research and industrial use; some can qualify for pharma	Purchase through chemical trading arms	Purity/HPLC spec, heavy metals, residual solvents, polymorph control (if relevant)
Contract manufacturers / tollers	Pyrazinamide made to a customer spec using internal chemistry	Supplier qualification program	Batch records, validation package, change-control process
Distributors / wholesalers	Inventory sourced from API manufacturers	Blanket PO with framework contracts	Manufacturer of record on COA, GDP documentation, lot-level documentation
Local repackagers (where allowed)	Repackaged API for lab or regional formulators	Regional procurement	Repackaging GMP statement and full COA transfer

Which regions dominate pyrazinamide supply?

Pyrazinamide supply is concentrated in industrial chemical clusters where commodity fermentation-free small molecules are produced at scale.

Region	Why it matters for procurement	Typical supply pattern
China	Large base of small-molecule chemical synthesis and API capacity	High volume, broad price range
India	Multiple API producers and toll manufacturing	Dossier-capable supply in pharma specs
Europe	Lower-cost commodity capacity is smaller; emphasis on compliance for EU workflows	Premium documentation, smaller volumes
MENA and LATAM	Procurement often routed through distributors or importers	Higher lead times for qualification lots

What specs and documentation usually govern qualified pyrazinamide API supply?

Pyrazinamide is typically purchased against pharmacopoeial quality and internal QA specs. Buyers commonly request the following items in RFQs.

Requirement	What you should request
Pharmacopoeia compliance	USP, BP, or EP compliance statement for each lot (as applicable)
Identity and assay	HPLC/GC method reference, acceptance criteria for assay and identity
Impurities	Spec for total impurities, individual impurity limits, and class of impurities
Residual solvents	ICH Q3C-aligned residual solvent targets if synthesis/solvent system warrants
Heavy metals	ICP or equivalent heavy metals limits
Water and other solids specs	Loss on drying (LOD) or moisture content specs
Particle/powder properties (if used in solid dosage forms)	Bulk density, tap density, particle size distribution if relevant to downstream processing
Microbial quality	Usually limited for API unless a non-sterile formulation step or special route requires it
GMP and batch traceability	Manufacturer GMP certificate and lot traceability from manufacturer of record
Stability	At least initial stability data (e.g., 25C/60% RH, 30C/65% RH) and ongoing stability commitment

How do buyers typically shortlist pyrazinamide suppliers?

Shortlists in pyrazinamide procurement usually hinge on two axes: (1) ability to supply consistent quality against a target pharmacopoeia and (2) documentation readiness for regulatory submission or inspection readiness.

Shortlisting criterion	Procurement impact
GMP footprint and audit history	Speeds qualification and reduces re-sampling risk
Pharmacopoeial alignment	Reduces formulation and release cycle friction
Impurity profile consistency	Reduces batch rejection risk in downstream compression/coating
Lead time and batch availability	Determines ability to support TB program demand cycles
Tech transfer support	Enables change-control robustness when formulation sites need updates
Dossier assets	Supports submissions when DMF/CEP-style filings exist

What do “pharma-grade” pyrazinamide supplier setups look like?

For pyrazinamide, “pharma-grade” usually means the API supplier operates under GMP and sells material with lot-specific COA and stability/impurity characterization aligned to the buyer’s target pharmacopoeia.

A typical pharma supply package includes:

• COA with identity, assay, impurities, LOD/moisture, residual solvents (if applicable), heavy metals, and physical tests.
• GMP certificate covering API manufacturing.
• DMF/CEP and/or audit-ready quality package depending on market.
• Method appendices or at least method references to the pharmacopoeial/general approach used for testing.
• Stability evidence and declared retest period based on ongoing stability.

What supplier channels are commonly used to obtain pyrazinamide in practice?

Channel	Best fit	Procurement downside
Direct from API manufacturer	Long-term supply, stronger lot traceability	Qualification workload and sometimes less responsive inventory visibility
Through a pharma distributor	Faster ordering, easier replenishment	You rely on distributor quality controls and manufacturer-of-record clarity
Toll manufacturing	Custom spec and impurity tailoring	Requires heavier validation and change-control governance
Multi-sourcing from commodity producers	Cost control and volume security	Higher QA burden for impurity profile and documentation consistency

Key procurement reality for pyrazinamide

Pyrazinamide behaves like a commodity small molecule in many markets: buyers often manage risk by multi-sourcing, locking to firm specs, and insisting on lot-level documentation (COA plus GMP/traceability). Supplier qualification is less about synthetic novelty and more about quality system consistency and impurity and stability control.

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Key Takeaways

• Pyrazinamide supply is dominated by commercial API manufacturers in China and India, plus distributors and toll manufacturers for qualification-driven sourcing.
• Qualified supply is governed by pharmacopoeial alignment, impurity profile consistency, and GMP/lot traceability rather than by proprietary technology.
• Procurement should prioritize supplier packages that include COA, GMP certificate, stability evidence, and impurity/residual solvent/heavy metal specs.
• Risk control for this commodity-style API comes from multi-sourcing plus lot-level documentation requirements.

FAQs

1) Is pyrazinamide treated like a specialty API or a commodity API for sourcing?

It is commonly sourced like a commodity small-molecule API, where price and documentation consistency drive supplier selection.

2) What documents matter most when qualifying a pyrazinamide API supplier?

A lot-level COA, the GMP certificate for the manufacturer of record, impurity/residual solvent/heavy metals specs, and stability evidence are the core qualification items.

3) Do distributors usually sell the same pyrazinamide API as the manufacturer?

Distributors typically source from an upstream manufacturer. The critical procurement control is ensuring the manufacturer of record is clearly identified on the COA and documentation packet.

4) What pharmacopoeia alignment is typically requested for pyrazinamide?

Buyers often request USP, BP, or EP alignment depending on market and regulatory pathway.

5) How do buyers reduce batch-to-batch variability risk with pyrazinamide?

They use tight specifications, request impurity profile and stability data, and apply a multi-source strategy with qualification cycles tied to lot release history.

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References

[1] United States Pharmacopeia (USP). USP–National Formulary. General information and standards for pharmaceutical substances. (Accessed via USP resources).
[2] European Pharmacopoeia (Ph. Eur.). General information and standards for pharmaceutical substances. (Accessed via European Pharmacopoeia resources).
[3] British Pharmacopoeia (BP). General information and standards for pharmaceutical substances. (Accessed via BP resources).