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Suppliers and packagers for generic pharmaceutical drug: isoniazid
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isoniazid
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ISONIAZID | isoniazid | INJECTABLE;INJECTION | 040648 | ANDA | Sandoz Inc | 0781-3056-70 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3056-70) / 10 mL in 1 VIAL, MULTI-DOSE | 2006-01-19 |
| Chartwell Rx | ISONIAZID | isoniazid | SYRUP;ORAL | 081118 | ANDA | Chartwell RX, LLC | 62135-550-47 | 473 mL in 1 BOTTLE (62135-550-47) | 1997-07-21 |
| Cmp Pharma Inc | ISONIAZID | isoniazid | SYRUP;ORAL | 088235 | ANDA | CMP Pharma, Inc. | 46287-009-01 | 473 mL in 1 BOTTLE (46287-009-01) | 1983-11-11 |
| Genus | ISONIAZID | isoniazid | TABLET;ORAL | 080936 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0066-02 | 100 TABLET in 1 BOTTLE (0555-0066-02) | 1972-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ISONIAZID Supplier Landscape: Who Manufactures and Supplies the API and Finished Dosage Forms
Executive summary:
The global isoniazid supply chain is dominated by Asian API manufacturers with broad CDMO/contract manufacturing activity for finished-dose tablets (often 50 mg, 100 mg, 300 mg). Market access is typically governed by (1) DMF/API approvals for US and EU dossiers, (2) cGMP status and site inspection outcomes, and (3) whether the supplier can support fixed-dose combinations (notably with rifampin, and in TB regimens) and pediatric dosing. This note maps the supplier universe by API and finished-dose supply roles and highlights the most common regulatory and commercial constraints for buyers.
Which companies supply isoniazid API (active pharmaceutical ingredient)?
Most isoniazid API sourcing is concentrated among a small set of established generic and TB-focused API players in India and China, with additional capacity in South and Southeast Asia. Buyers typically qualify API suppliers via DMF cross-references (US) and CEP or national dossier filings (EU), with batch release driven by pharmacopeial compliance (USP/EP) and impurity profiles.
API supplier role and qualification pattern
- API manufacturers file Drug Master Files (DMFs) for isoniazid (commonly Type II) for US import and manufacturing support.
- EU buyers commonly rely on CEP-backed API supply or site dossier approvals for isoniazid.
- Finished-dose manufacturers often source from multiple API sites to manage lead times and inspection risk.
Common API sourcing geographies
- India: largest installed base for commodity TB APIs.
- China: major scale API production with export-oriented quality systems.
- Additional capacity: Pakistan and other regional producers supply lower-cost API, typically for ROW markets unless US/EU qualification is achieved.
What finished-dose manufacturers supply isoniazid tablets (50 mg, 100 mg, 300 mg)?
Finished-dose supply is split between (1) branded legacy producers and (2) generic manufacturers with TB-focused portfolios that maintain tablet lines and stability data for multiple strengths. Isoniazid is a core first-line TB agent, so tablet supply is usually stable and diversified across multiple suppliers.
Tablet dosage strengths and packaging
Common tablet strengths in supply chains include:
- 50 mg
- 100 mg
- 300 mg
Packaging formats vary by market:
- Bottle tablets for US and EU distribution
- Blister packs for EU and ROW where pack-barcode and serialization readiness is required
Regulatory drivers for finished doses
- US: FDA OTC labeling and current Good Manufacturing Practice with NDA/ANDA-linked product quality oversight.
- EU: compliance with GMP, QP release, and national labeling requirements under the EU variation system.
How does isoniazid DMF status affect supplier eligibility in the US?
US procurement typically requires a supplier that either:
- holds an active DMF that the finished-dose applicant references, or
- supports an ANDA/NDA product-specific quality agreement, depending on buyer structure.
Typical DMF-related buyer checks
- DMF Type and reference status by the finished-dose applicant
- Current good manufacturing practice and audit outcomes
- Ability to provide impurity and residual solvent specs consistent with USP/EP monographs
Lead-time impact
A supplier without an established DMF reference network can face longer qualification cycles for finished-dose launches due to dossier cross-reference and CMC support.
What patents or exclusivity affect isoniazid supply and generic entry?
Isoniazid is long off patent in most jurisdictions, and supply competition is governed more by manufacturing authorization and quality systems than by IP blocking.
Practical implication for sourcing
- Buyers usually face fewer IP constraints and more cGMP and dossier constraints.
- Supplier selection focuses on:
- inspection history
- impurity control capability
- ability to supply consistent particle size, polymorph behavior (as applicable), and stability
What is the Orange Book status of isoniazid products?
For older TB medicines like isoniazid, Orange Book protections (listed patents and exclusivity) are generally limited or expired, making multiple generics available in most markets. Supply availability is therefore driven by manufacturing capacity rather than patent barriers.
Which contract manufacturers and CDMOs support isoniazid tablet production?
Isoniazid tablet manufacturing is commonly performed by:
- generic pharmaceutical companies with internal tableting lines, and
- CDMOs that take on tablet compression, coating (if any), blistering/bottling, and packaging.
What buyers typically require from CDMOs
- Tablet compression capacity with validated control strategy for hardness, friability, disintegration
- Stability program aligned with market shelf-life requirements
- End-to-end traceability and batch record integrity systems
How many qualified isoniazid suppliers exist in key markets (US, EU, UK)?
Supplier counts vary by:
- whether the measure is API DMF holders vs finished-dose labeled products, and
- whether inclusion requires active FDA/EU readiness within the last inspection cycle.
Operationally, most buyers can find multiple qualified sources for both API and tablets, but not all are equally prepared for US/EU dossier referencing.
What are common supply constraints for isoniazid API and tablets?
Despite broad competition, constraints show up during:
- regulatory inspection cycles at specific API or tableting sites
- impurity spec excursions tied to starting material variability
- packaging and labeling compliance changes
- raw-material procurement constraints during monsoon and shipping disruptions in major manufacturing hubs
Quality points that can tighten supply
- impurity profile consistency over time
- assay and moisture control
- congruence with pharmacopeial monographs used by target markets
Supplier comparison: API-only vs finished-dose suppliers
| Supplier type | What they provide | Buyer advantage | Buyer risk |
|---|---|---|---|
| API manufacturer | Isoniazid API with specs and batch COAs | Lower raw cost, control of formulation supply chain | Requires buyer to manage tableting and regulatory CMC linkage |
| Finished-dose manufacturer | Tablets in target strength with regulatory-ready packaging | Faster market access, less formulation development burden | Higher unit cost and less flexibility if supply is constrained |
| CDMO | Manufacturing plus packaging support | Capacity scalability and outsourced compliance | Dependency on CDMO change control and validation timelines |
What documentation do buyers typically require from isoniazid suppliers?
For procurement and regulatory audits, buyers usually require:
- GMP compliance statement for the relevant site(s)
- COA with assay, impurities, water content (as specified), and residual solvents (if relevant)
- DMF/CEP/marketing authorization cross-references where applicable
- Stability data package or commitment to provide updates aligned to shelf life
What manufacturing/IP barriers most often delay isoniazid supply onboarding?
Because isoniazid is off patent, onboarding friction usually comes from:
- dossier referencing readiness (US DMF links or EU QP dossier status)
- site inspection readiness and remediation capacity
- change control limitations on API supplier transfers and analytics qualification
Key Takeaways
- Isoniazid supply is diversified and generally not blocked by active IP, with regulatory qualification and cGMP readiness driving supplier selection.
- API sourcing is concentrated in India and China, with finished-dose tablet supply spread across generic and TB-specialist manufacturers.
- Buyer diligence should focus on DMF/registration readiness (US), GMP inspection outcomes (US/EU), impurity profile control, and the supplier’s ability to maintain stable tablet performance and packaging compliance.
FAQs
Which suppliers consistently provide isoniazid tablets at scale?
Large generic and TB-focused manufacturers with established US/EU distribution typically maintain multi-source API sourcing and dedicated tableting lines for commodity strengths.
What is the difference between buying isoniazid API and isoniazid tablets for procurement?
API sourcing shifts formulation and CMC responsibility to the buyer, while tablets shift responsibility to the manufacturer but reduce qualification and formulation burden.
How do API impurity profiles affect isoniazid batch acceptance?
Inconsistent impurity control is a common cause of rejection during release, particularly if starting material variability changes.
Do isoniazid suppliers need specific dossier filings for the EU?
EU procurement typically relies on national approvals, CEP-style documentation, and QP release compliance rather than a single universal US-style DMF.
What happens to isoniazid supply during regulatory inspection cycles?
If an API or tableting site is restricted or remediation is ongoing, qualified supply can tighten quickly until alternate sites ramp and analytics are revalidated.
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- European Medicines Agency. (n.d.). EPARs and related quality information for medicines. https://www.ema.europa.eu/en
- FDA. (n.d.). DMF (Drug Master File) information and FDA guidance resources. https://www.fda.gov/drugs/drug-master-files-dmfs
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