Pharmaffiliates - Gefitinib - An EGFR inhibitor

In early 90’s, lung cancer had become a common cause of death worldwide, as at the time of diagnosis the patients are in the advanced stages of the disease. Apart from several chemotherapy techniques, new and effective treatment options were urgently needed.Gefitinib, an anti-cancer drug which was approved by US-FDA in the year 2003 for the treatment of advanced non-small-cell lung cancer.

Gefitinib is a synthetic anilinoquinazoline, which is orally available and acts as an inhibitor of tyrosine kinase activity of the epidermal growth factor receptor (EGFR).Gefitinib which is sold under the trade name of ‘Iressa’ is a trademark of Astra Zeneca group of companies. It shows single-agent activity and mild toxicity profile in patients suffering from non-small-cell lung cancer for whom no other treatment exists.

Hence this drug has been observed as new and indispensable choice for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). Various pharmaceutical companies have been manufacturing Gefitinib, keeping in view the necessity and advantage of this potent anti-cancer drug.Pharmaffiliates Analytics and Synthetics P. Ltd, a world leading CRO located in North India, has been synthesizing the In house Reference standards of Gefitinib and the impurities related with Gefitinib.

Pharmaffiliates offers best quality (over 98%) reference standards which are synthesized In-house in a state-of-art facility by a professionally qualified and skilled team of scientists. Detailed Certificate of Analysis which is duly verified by the QA department is also provided with the Reference standard.The Reference standards of the following impurities of Gefitinib are available in Pharmaffiliates:

Gefitinib Impurity A (7-METHOXY-6-(3-MORPHOLINOPROPOXY)QUINAZOLIN-4(3H)-ONE)- an intermediate in the synthesis of Gefitinib.

Gefitinib Impurity B (3-DESCHLORO-4-DESFLUORO-4-CHLORO-3-FLUORO GEFITINIB)- an impurity of Gefitinib.

3-Chloro-4-Fluorophenylamine – an important synthon used in the synthesis of Gefitinib.

Gefitinib 4-Desfluoro Hydrochloride Impurity - an impurity of Gefitinib.

Gefitinib N-Oxide - a degradation impurity of Gefitinib.

O-Des Morpholino propyl Gefitinib – a metabolite of Gefitinib.

Pack sizes of all the above mentioned In-house Reference standards are provided in 25mg and 50mg vials. Customized pack sizes as per the customer’s need are also obtainable at Pharmaffiliates.