Reference to your mail dated 15/07/2016 regarding Erythromycin Estolate BP 2005
of Batch Nos. EE050B 16 & EE013E 16 having granules mixed with powder material
We wish to reply as under
1. We have carried out initial investigation and discussed with all the relevant departments.
2. As per our initial investigation no Deviation was observed in the BMCR/BPCR .
3. We have checked QC protocols & no untoward observation is noted..
4. We have checked our control sample of both the batches, there is no any granules material observed.
5. We also carried out sieve analysis through 30 mesh.. 100 % material of both the batches passing through 30 mesh.