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Osi-774 (Erlotinib) API Manufacturers & Suppliers

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Commercial-scale Suppliers

Producer
Produced in  India
|

Employees: 5000+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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EDMF/ASMF
|
MSDS
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BSE/TSE

All certificates

GMP
USDMF
EDMF/ASMF
MSDS
BSE/TSE
ISO9001
WC
CoA
Distributor
Produced in  United States
|

Employees: 50+

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
MSDS
|
BSE/TSE
|
ISO9001
|
CoA

All certificates

GMP
MSDS
BSE/TSE
ISO9001
CoA
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Producer
Produced in  India
|

Employees: 200+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
MSDS
|
BSE/TSE
|
CoA

All certificates

GMP
MSDS
BSE/TSE
CoA
Producer
Produced in  China
|

Employees: 25+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
USDMF
|
ISO9001
|
CoA

All certificates

GMP
USDMF
ISO9001
CoA
Distributor
Produced in  China
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
ISO9001
|
CoA

All certificates

USDMF
ISO9001
CoA
Producer
Produced in  South Korea
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
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€399,-
All Erlotinib data. Full access. Full negotiation power
Producer
Produced in  Unknown
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

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USDMF
CoA
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
WC
|
CoA

All certificates

GMP
WC
CoA
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Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: WC
|
CoA

All certificates

WC
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
WC
|
CoA

All certificates

USDMF
WC
CoA
Producer
Produced in  China
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
|
CoA
|
WC

All certificates

USDMF
CoA
WC
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€399,-
All Erlotinib data. Full access. Full negotiation power
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
WC
|
CoA

All certificates

GMP
WC
CoA
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
USDMF
|
WC
|
KDMF

All certificates

GMP
FDA
USDMF
WC
KDMF
coa
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
coa

All certificates

GMP
coa
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Not active
Take control of your API sourcing
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Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Not active
Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Not active
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Not active
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Not active
Get full market intelligence report
Get full market intelligence report
€399,-
All Erlotinib data. Full access. Full negotiation power
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
USDMF
|
WC
|
CoA

All certificates

GMP
USDMF
WC
CoA
Not active
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Erlotinib | CAS No: 183321-74-6 | GMP-certified suppliers

A medication that treats metastatic non-small cell lung cancer with specific EGFR mutations and is used with first-line therapy for advanced pancreatic cancer.

Therapeutic categories

Antineoplastic AgentsAntineoplastic and Immunomodulating AgentsBCRP/ABCG2 InhibitorsCytochrome P-450 CYP1A2 SubstratesCytochrome P-450 CYP1A2 Substrates with a Narrow Therapeutic IndexCytochrome P-450 CYP2C8 Inhibitors
Generic name
Erlotinib
Molecule type
small molecule
CAS number
183321-74-6
DrugBank ID
DB00530
Approval status
Approved drug, Investigational drug
ATC code
L01EB02

Primary indications

  • Erlotinib is indicated for:
  • The treatment of metastatic non-small cell lung cancer (NSCLC) with tumors showing epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
  • In combination with first-line treatment for patients diagnosed with locally advanced, unresectable or metastatic pancreatic cancer
  • The safety and efficacy of erlotinib have not been established for patients with NSCLC whose tumors show other EGFR mutations

Product Snapshot

  • Erlotinib is an oral small molecule formulated as film-coated tablets
  • It is primarily used in the treatment of metastatic non-small cell lung cancer with specific EGFR mutations and in combination therapy for locally advanced or metastatic pancreatic cancer
  • Erlotinib is approved in key regulatory markets including the US, Canada, and the European Union

Clinical Overview

Erlotinib (CAS number 183321-74-6) is an orally active small molecule inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. It is indicated primarily for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors harbor specific EGFR mutations, notably exon 19 deletions or exon 21 (L858R) substitution mutations. Additionally, erlotinib is approved in combination with first-line therapy for patients with locally advanced, unresectable or metastatic pancreatic cancer. Its use in NSCLC patients with other EGFR mutations or in combination with platinum-based chemotherapy is not recommended due to lack of established safety and efficacy.

Pharmacologically, erlotinib competitively and reversibly binds to the ATP-binding site of EGFR tyrosine kinase, inhibiting intracellular phosphorylation events critical for signal transduction pathways involved in tumor cell proliferation and survival. Although the precise mechanisms underlying its antitumor activity are not fully elucidated, it selectively targets EGFR expressed on both normal and cancerous cells. Recent findings also identify erlotinib as a potent inhibitor of the mutant JAK2V617F kinase, suggesting potential investigative applications in myeloproliferative disorders such as polycythemia vera.

Erlotinib belongs to quinazolinamine derivatives, a class of heterocyclic aromatic compounds. Its metabolism is primarily hepatic, involving cytochrome P450 enzymes—especially CYP3A4 and CYP1A2 isoforms—with known interactions affecting these metabolic pathways. Erlotinib exhibits a narrow therapeutic index and is classified as a substrate and inhibitor of multiple cytochrome P450 enzymes and drug transporters including P-glycoprotein and organic anion transporting polypeptide 2B1. These characteristics necessitate careful consideration of potential drug-drug interactions.

Safety considerations include risks associated with QTc prolongation, hepatic toxicity, interstitial lung disease, and dermatologic adverse effects. Close monitoring of cardiac and hepatic function is recommended during therapy.

Erlotinib is predominantly marketed under the trade name Tarceva. Quality considerations for API procurement focus on stringent adherence to regulatory standards for identity, purity, polymorphic form, and impurity profiles due to the narrow therapeutic index and complex metabolism. Suppliers must ensure comprehensive documentation and compliance with current Good Manufacturing Practices to support global regulatory submissions.

Identification & chemistry

Generic name Erlotinib
Molecule type Small molecule
CAS 183321-74-6
UNII J4T82NDH7E
DrugBank ID DB00530

Pharmacology

SummaryErlotinib is a tyrosine kinase inhibitor that targets the intracellular phosphorylation of the epidermal growth factor receptor (EGFR), a receptor expressed on both normal and cancerous cells. It is primarily used to inhibit EGFR-driven signaling pathways involved in tumor cell proliferation and survival in certain non-small cell lung cancers and pancreatic cancers. Its inhibitory specificity for other tyrosine kinase receptors remains incompletely characterized.
Mechanism of actionThe mechanism of clinical antitumor action of erlotinib is not fully characterized. Erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with the epidermal growth factor receptor (EGFR). Specificity of inhibition with regard to other tyrosine kinase receptors has not been fully characterized. EGFR is expressed on the cell surface of normal cells and cancer cells.
Targets
TargetOrganismActions
Nuclear receptor subfamily 1 group I member 2Humansagonist
Epidermal growth factor receptorHumansantagonist

ADME / PK

AbsorptionErlotinib is about 60% absorbed after oral administration and its bioavailability is substantially increased by food to almost 100%. Peak plasma levels occur 4 hours after dosing. The solubility of erlotinib is pH dependent. Solubility decreases pH increases. Smoking also decrease the exposure of erlotinib.
Half-lifeMedian half-life of 36.2 hours.
Protein binding93% protein bound to albumin and alpha-1 acid glycoprotein (AAG)
MetabolismMetabolism occurs in the liver. In vitro assays of cytochrome P450 metabolism showed that erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2, and the extrahepatic isoform CYP1A1.
Route of eliminationFollowing a 100 mg oral dose, 91% of the dose was recovered in which 83% was in feces (1% of the dose as unchanged parent compound) and 8% in urine (0.3% of the dose as unchanged parent compound).
Volume of distributionApparent volume of distribution = 232 L
ClearanceSmokers have a 24% higher rate of erlotinib clearance.

Formulation & handling

  • Erlotinib is a small molecule API formulated for oral administration as film-coated tablets.
  • Administer erlotinib on an empty stomach to avoid increased bioavailability and potential variability in drug exposure.
  • Handle with consideration of CYP3A4 interactions, notably with grapefruit products and St. John's Wort, which can alter metabolism and serum levels.

Regulatory status

LifecycleThe API's key patents in Canada and the United States expired between 2015 and 2024, indicating that the product is in a mature market phase with established availability in Canada, the US, and the EU. Generic or alternative versions may be present in these regions.
MarketsCanada, US, EU
Supply Chain
Supply chain summaryErlotinib is originally manufactured by a limited number of companies, with several packagers involved in its supply chain. The branded products have a significant presence across major markets including the US, EU, and Canada. Patent expirations, notably between 2019 and 2024 in the US and Canada, indicate that generic competition is either present or imminent in these regions.

Safety

ToxicitySymptoms of overdose include diarrhea, rash, and liver transaminase elevation. The most common adverse reactions (>50%) in NSCLC are rash, diarrhea, anorexia and fatigue. The most common adverse reactions (>50%) in pancreatic cancer are fatigue, rash, nausea and anorexia.
High Level Warnings:
  • Overdose may result in gastrointestinal disturbances, dermatologic reactions, and elevated hepatic transaminases
  • Adverse effects with high incidence include rash, diarrhea, fatigue, anorexia, and nausea, varying by cancer indication
  • Monitor for potential hepatotoxicity indicated by transaminase elevations during handling and formulation

Erlotinib is a type of Protein kinase inhibitors


Protein kinase inhibitors are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in targeted cancer therapies. These inhibitors specifically target and block the activity of protein kinases, enzymes that regulate various cellular processes, including cell growth, division, and signal transduction.

Protein kinase inhibitors function by binding to the active site of protein kinases, preventing them from phosphorylating specific proteins and disrupting intracellular signaling pathways. This targeted approach inhibits the uncontrolled growth and proliferation of cancer cells, ultimately leading to their death.

The development of protein kinase inhibitors has revolutionized cancer treatment by providing more effective and less toxic alternatives to traditional chemotherapy. These drugs have demonstrated impressive results in the treatment of various cancers, including lung, breast, and leukemia.

The pharmaceutical industry invests heavily in research and development to discover novel protein kinase inhibitors with improved potency, selectivity, and pharmacokinetic properties. High-throughput screening, computational modeling, and structure-activity relationship studies are employed to identify potential lead compounds.

The success of protein kinase inhibitors in treating cancer has spurred significant interest in this subcategory of APIs. Ongoing research aims to expand their applications to other diseases, such as autoimmune disorders and neurological conditions.

In conclusion, protein kinase inhibitors are a valuable class of pharmaceutical APIs with immense potential for targeted cancer therapies. Continued advancements in this field hold promise for improved treatment outcomes and enhanced patient care.


Erlotinib (Protein kinase inhibitors), classified under Anticancer drugs


Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.

Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.

These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.

Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.



Erlotinib API manufacturers & distributors

Compare qualified Erlotinib API suppliers worldwide. We currently have 21 companies offering Erlotinib API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
India India CoA, GMP14 products
Producer
China China CoA, USDMF10 products
Producer
India India CoA, USDMF164 products
Producer
China China CoA, WC7 products
Producer
India India BSE/TSE, CoA, GMP, MSDS166 products
Producer
India India CoA, GMP, USDMF, WC90 products
Producer
United Kingdom Unknown CoA, USDMF30 products
Producer
South Korea South Korea CoA32 products
Producer
India India CoA, GMP, WC50 products
Producer
India India CoA, GMP, WC25 products
Producer
India India CoA, USDMF119 products
Producer
India India CoA, USDMF201 products
Producer
India India CoA, FDA, GMP, KDMF, USDMF, WC40 products
Producer
China China CoA, USDMF, WC33 products
Producer
India India CoA, USDMF, WC11 products
Distributor
United States United States BSE/TSE, CoA, GMP, ISO9001, MSDS144 products
Producer
China China CoA, GMP, ISO9001, USDMF157 products
Distributor
China China CoA162 products
Producer
India India BSE/TSE, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, USDMF, WC54 products
Distributor
China China CoA, ISO9001, USDMF757 products
Producer
India India CoA, USDMF219 products

When sending a request, specify which Erlotinib API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Erlotinib API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.