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Shilpa Medicare gains post EU-GMP approval for three plants

Shilpa Medicare has received EU-GMP approval for two API plants and one formulations plant.
Shilpa Medicare informed the exchanges that two API Manufacturing Plants located at Raichur and a formulation facility located at Jadcherla have received EU-GMP certification from Austrian Agency, AGES.

AGES carried out inspection of these API plants at Raichur between January 16-24, 2018 and Formulation Facility at Jadcherla between January 25-31, 2018.

Jadcherla is Shilpa Medicare’s only injectable formulations manufacturing facility. Company has received an EIR with VAI status in March 2018. In December 2017, this facility had received 10 form 483 observations from the USFDA.

The API units in Raichur, however, have outstanding form 483 with 3 observations since January 2018.

Shilpa Medicare Ltd is currently trading at Rs463.95, up by Rs11.3 or 2.5% from its previous closing of Rs452.65 on the BSE.