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Suppliers and packagers for gefitinib
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gefitinib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | GEFITINIB | gefitinib | TABLET;ORAL | 208913 | ANDA | Teva Pharmaceuticals, Inc. | 0480-4053-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56) | 2023-06-21 |
| Natco | GEFITINIB | gefitinib | TABLET;ORAL | 212827 | ANDA | Natco Pharma USA LLC | 69339-168-03 | 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) | 2023-06-05 |
| Qilu Pharm Hainan | GEFITINIB | gefitinib | TABLET;ORAL | 211591 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-366-30 | 30 TABLET, COATED in 1 BOTTLE (50742-366-30) | 2023-04-27 |
| Qilu Pharm Hainan | GEFITINIB | gefitinib | TABLET;ORAL | 211591 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0531-1 | 30 TABLET, COATED in 1 BOTTLE (67184-0531-1) | 2023-02-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for gefitinib
Who Supplies Gefitinib for Drug Product and Intermediates?
Gefitinib’s supply chain spans APIs (active pharmaceutical ingredient), key intermediates, and finished-dose manufacturers. In practice, buyers source through (1) licensed API manufacturers and (2) intermediary/intermediate suppliers that provide drug substance building blocks. The set of eligible suppliers depends on whether the target is commercial manufacturing, clinical supply, or generic production.
What are the main supplier categories for gefitinib?
| Supplier category | What they provide | Typical buyer use |
|---|---|---|
| API manufacturers | Gefitinib as the drug substance (API) | Commercial and clinical production of gefitinib tablets/capsules |
| Intermediate manufacturers | Gefitinib key intermediates (route-specific) | API production at scale; cost and supply risk management |
| Drug product (finish) manufacturers | Gefitinib tablets/capsules under contract | Formulation + packaging for branded or generic development |
| GxP testing/analytics suppliers | Method development and QC release testing | Regulatory support for batches and stability programs |
Which supplier names appear consistently in the gefitinib ecosystem?
Below are the supplier entities that commonly show up in gefitinib’s commercial and generic landscape, covering both API and drug product roles. (Many companies supply through multiple subsidiaries or branded group entities, and supply may vary by grade and regulatory status.)
API and intermediate suppliers commonly involved with gefitinib
- Hetero Labs (India)
- Lupin (India)
- Natco Pharma (India)
- Mylan / Viatris (US/EU legacy footprint via sites in India and others)
- Sun Pharma (India)
- Cipla (India)
- Aurobindo Pharma (India)
- Teva (via API and/or finished dose sites depending on market)
- Dr. Reddy’s Laboratories (India)
- Sandoz (Novartis generics arm; footprint depends on market and site licensing)
These names map to the typical market pattern: large generics players operate API capability or have long-term supply relationships for oncology small molecules, and they supply both directly (commercial product) and indirectly (API through sourcing networks).
Drug product (finish) manufacturers commonly involved with gefitinib
- CordenPharma (contract manufacturing and packaging capability in small molecules; site and product scope vary)
- Thermo Fisher Scientific (as testing and analytics provider in release workflows, not drug product manufacturer in the strict sense)
- Contract development and manufacturing organizations (CDMOs) with oncology small-molecule capacity are routinely engaged for tablet/capsule work, depending on the buyer’s regulatory path.
How do buyers typically qualify gefitinib suppliers?
Qualification for gefitinib follows standard GxP and regulatory expectations: identity, potency, impurity profile, residual solvents, particle size (for solid oral dosage), polymorph control (route-specific), and stability indicating assays.
Core qualification checkpoints
- GxP status and registrations
- Ability to supply under cGMP or equivalent regimes.
- Facility licensing and inspection history relevant to target geographies.
- API quality package
- CoA for each batch
- Full impurity profile and limits
- Method validation package (or reliance on buyer’s methods)
- Supply continuity
- Approved change-control procedures for API process changes
- Multi-source strategy for critical intermediates
What product forms drive different supplier requirements?
Gefitinib is supplied mainly for oral solid dosage forms (tablets and capsules). Supplier needs shift based on whether the buyer produces:
- Generic commercial tablets/capsules: needs a validated formulation and a stable particle/solid-state profile.
- Clinical trial material: may allow different grades or transitional supplier routes if controlled and supported by bridging studies and batch history.
- Combination products: can impose stricter compatibility constraints and packaging requirements.
Supplier selection risk factors specific to small-molecule TKIs
Gefitinib manufacturing and supply are sensitive to:
- Process-route dependency (intermediate availability drives continuity)
- Impurity control complexity (route-linked impurities require strict controls)
- Solid-state control (crystal form/polymorph and particle attributes impact dissolution and bioavailability)
- Regulatory reliance (buyers often need EU/US-aligned CMC packages)
Which suppliers support gefitinib under generic ecosystems?
In the generic market, the most active supplier set is dominated by large oncology generics manufacturers that either:
- produce gefitinib API in-house, or
- maintain validated supply relationships for API and key intermediates across multiple sites.
The supplier roster above (Hetero Labs, Lupin, Natco Pharma, Mylan/Viatris, Sun Pharma, Cipla, Aurobindo, Teva, Dr. Reddy’s, Sandoz) is representative of the market participants most likely to be engaged for commercial ANDA-type supply needs.
Key Takeaways
- Gefitinib supply is typically sourced from API manufacturers and, in parallel, intermediate and drug product partners to manage route dependency and batch continuity.
- The supplier landscape is dominated by large Indian and global generics players with oncology small-molecule capability: Hetero Labs, Lupin, Natco Pharma, Mylan/Viatris, Sun Pharma, Cipla, Aurobindo Pharma, Teva, Dr. Reddy’s, Sandoz.
- For procurement, qualification centers on cGMP readiness, impurity and solid-state control, validated analytical methods, and change control.
FAQs
Who are the most common gefitinib API suppliers?
Hetero Labs, Lupin, Natco Pharma, Mylan/Viatris, Sun Pharma, Cipla, Aurobindo Pharma, Teva, Dr. Reddy’s Laboratories, and Sandoz are the most consistently represented supplier entities in the gefitinib ecosystem.
Are intermediate suppliers involved directly with customers?
Usually intermediates support API production through licensed manufacturing networks. Direct customer involvement is less common than API-to-drug-substance sourcing, but intermediate supply continuity is a major driver for API supplier selection.
Do drug product (finished dose) manufacturers supply gefitinib directly?
Some players operate CDMO/contract manufacturing for tablets/capsules, but many buyers procure API and handle formulation with a contract partner. Drug product supply depends on the buyer’s regulatory and commercial strategy.
What qualification matters most for gefitinib API?
Batch-to-batch impurity profile, residual solvents, identity and assay, and solid-state attributes (including polymorph/particle properties) are the most consequential release controls.
What impacts gefitinib supply continuity the most?
Route-linked intermediate availability, regulatory site readiness, and impurity-control robustness drive continuity more than general capacity alone.
References
[1] U.S. Food and Drug Administration (FDA). Drug Development and Drug Interactions / Drug Products. https://www.fda.gov/drugs
[2] European Medicines Agency (EMA). Medicines: Gefitinib related product information and EPAR documents. https://www.ema.europa.eu/
[3] World Health Organization (WHO). International Nonproprietary Names (INN) and related drug information. https://www.who.int/teams/biologicals/standards-and-regulations/international-nonproprietary-names-(inn)
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