Sun Pharmaceutical Industries Limited

Hari Babu Matta

Mohan Prasad

Mahavir Singh Khanna

The present invention relates to pure crystalline Form II of an L-malic acid salt of sunitinib and a process for its preparation. The invention further provides crystalline Form II of an L-malic acid salt of sunitinib having a purity of at least 97.0%. The invention also provides crystalline Form II of an L-malic acid salt of sunitinib substantially free of an anti-oxidant. The invention also provides crystalline Form II of L-malic acid salt of sunitinib which remains chemically pure on storage at 25&#xb0; C.&#xb1;2&#xb0; C. and 40&#xb0; C.&#xb1;2&#xb0; C. at a relative humidity of 60%&#xb1;5% and 75%&#xb1;5%, respectively, for at least 1 month.

Pure crystalline Form II of L-malic acid salt of sunitinib and processes for its preparation

The present invention relates to an ascorbic acid salt of sunitinib and a process for its preparation. The present invention further provides a crystalline Form I of an L-ascorbic acid salt of sunitinib.

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Prakasam, India

Hari Babu Matta