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Shilpa Medicare gets EIR at two API facilities

These two API units had received form 483 with 3 observations in January 2018 inspection and have now been cleared by USFDA.

Shilpa Medicare has received EIR (Establishment Inspection Report) from USFDA to its two API manufacturing facilities located at Raichur, Karnataka. The inspection was carried out between 16-19 January, 2018. The inspection has now been closed by USFDA, which means that both the facilities have now clearance from the USFDA.

These API units had received form 483 with 3 observations in January 2018 inspection.

The company has also received EU-GMP certification from Austrian Agency, AGES for these two API facilities. Its formulation facility located at Jadcherla also has EIR with VAI status and also EU-GMP certification.

Shilpa Medicare is a Raichur based pharma company, which manufactures high-quality Active Pharmaceutical Ingredients (APIs), Intermediates, Formulations, etc. It has eight manufacturing facilities, which have regulatory approvals from international drug regulators, including USFDA. The company is also setting up another formulation plant, which will commission in FY19E. It has more than 30 ANDA and has launched gVidaza and gXeloda in the US market.
We have a target price of Rs438 on Shilpa medicare. Read IIFL view on Shilpa Medicare.

Shilpa Medicare Ltd is currently trading at Rs432.15 up by Rs48.65 or 12.69% from its previous closing of Rs383.50 on the BSE.

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