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Lupin’s Pithampur Unit-1 facility receives EIR from US FDA
expresspharma
April 30, 2020
The inspection for the facility was conducted by the US FDA between February 3, 2020 and February 11, 2020 and concluded with two observations.
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Biocon Biologics gets EIR from US FDA for two manufacturing facilities
expresspharma
April 17, 2020
The formal closure of the US FDA inspection is expected to enable filing of marketing authorisation applications for the company's biosimilar products in several global markets.
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Lupin’s Aurangabad Facility Receives EIR from US FDA
expresspharma
April 06, 2020
The inspection for the facility was carried out between February 10, 2020 and February 14, 2020 and concluded with no observations.
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Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from US FDA
expresspharma
April 01, 2020
The Inspection has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Feb 2020.
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Lupin’s Inhalation Research Center, Florida receives EIR from US FDA
expresspharma
March 31, 2020
Pharma major Lupin announced the receipt of the Establishment Inspection Report (EIR) from the US FDA for its Inhalation Research Center located at Coral Springs, Florida.
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Strides announces successful completion of US FDA inspection conducted at Bangalore facility
expresspharma
March 31, 2020
Strides Pharma Science announced that it has received the Establishment Inspection Report (EIR) for the inspection conducted by the US FDA in January 2020 at Company’s flagship facility KRS Gardens, Bangalore.
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Lupin’s Pithampur Unit-3 receives EIR from US FDA
expressbpd
December 11, 2018
The facility manufactures dermatological products, dry product inhalers and metered dose inhalers
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Sun Pharma receives EIR for Halol facility
financialexpress
June 14, 2018
Sun Pharma announced that it has received the Establishment Inspection Report (EIR) from the US FDA for the inspection conducted at its Halol facility (Gujarat, India) during the period February 12-23, 2018.
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Granules India gets EIR for Telangana facility
financialexpress
May 21, 2018
Granules India announced that the US health regulator has issued the Establishment Inspection Report (EIR) after completing the audit of its Telangana facility.
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Dr Reddy's receives EIR from USFDA for UK plant
biospectrumasia
April 25, 2018
Dr Reddy's Laboratories has received an establishment inspection report (EIR) from the US health regulator after audit of its UK facility