Erlotinib bulk supplier for pharma manufacturers

Erlotinib 25 mg, 100 mg, 150 mg Suppliers & Bulk Manufacturers

Available Forms: Oral Tablets

Available Strengths: 25 mg, 100 mg, 150 mg

Reference Brands: Tarceva (US & EU)

Erlotinib film-coated tablets 25 mg, 100 mg and 150 mg, an EGFR tyrosine kinase inhibitor for lung and pancreatic cancer. For hospital pharmacies, oncology distributors, importers and tender buyers.

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Product Description:

Erlotinib is an oral tyrosine kinase inhibitor that blocks the epidermal growth factor receptor (EGFR). In tumours driven by an activating EGFR mutation, that signal keeps cancer cells dividing, and erlotinib switches it off. This page covers film-coated tablets of 25 mg, 100 mg and 150 mg. The 150 mg tablet is the usual daily dose in lung cancer and 100 mg in pancreatic cancer, while 25 mg lets the dose be stepped down when side effects need managing.

The main use is non-small cell lung cancer with an EGFR activating mutation, such as an exon 19 deletion or exon 21 L858R, so a validated mutation test comes first. It is also licensed with gemcitabine for metastatic pancreatic cancer. The tablet is taken once daily on an empty stomach. Strong CYP3A4 inhibitors raise levels and inducers lower them. Proton pump inhibitors reduce absorption, and smoking cuts exposure. Rash and diarrhoea are common; interstitial lung disease and liver injury need prompt review.

Sourcing notes. Erlotinib is prescription-only. A generic normally needs a CTD dossier with bioequivalence data against the reference product. The active is erlotinib hydrochloride, with strengths stated as base, so check that label and CoA agree. Tablets come in aluminium blisters or HDPE bottles; ask for zone IVb stability data for hot, humid markets. Erlotinib tablets keep at room temperature and need no cold chain. Each lot should carry a CoA, backed by a GMP certificate and a CoPP. In the enquiry, give strengths, pack size, quantity and destination.

Erlotinib — third party manufacturing & bulk supply

Erlotinib 25 mg, 100 mg, 150 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Erlotinib is supplied as Oral Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Erlotinib listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Erlotinib is used in the treatment of certain types of cancer, particularly non-small cell lung cancer (NSCLC) and pancreatic cancer. It is often prescribed for patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.

Erlotinib Hydrochloride is a synthetic small-molecule inhibitor that targets the epidermal growth factor receptor (EGFR) tyrosine kinase. By blocking EGFR signaling, it helps slow or stop the growth of cancer cells.

The most well-known trade name is Tarceva.

The original brand Tarceva was developed and marketed by Roche and Astellas Pharma. Many pharmaceutical companies now manufacture generic versions worldwide.

The generic name is Erlotinib Hydrochloride.

Brand names include Tarceva, Erlocip, Erlonat, and several generic versions marketed globally.

Erlotinib products are manufactured in several countries including the United States, Switzerland, India, and various EU pharmaceutical manufacturing hubs depending on the manufacturer.