|
Private Sector | Goa - India | PID: 191257
|
|
Indoco Remedies Limited announced today, the receipt of Establishment Inspection Report (EIR), from the US Food and Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa for the inspection carried out between 7th October to 15th October, 2019. This was a Pre-Approval Inspection for a sterile injectable product, with 2 observations on Form 483s, which is now concluded as closed.
The inspection classification of this site has been determined as VAI (Voluntary Action Indicated) by the USFDA.
Commenting on the receipt of the EIR, Ms. Aditi Kare Panandikar, Managing Director - Indoco Remedies Ltd., said, "We have received the EIR in just over a month's time from the date of inspection. Excelling at Quality and Compliance is one of our top priorities, as we remain committed to meeting and exceeding standards set by the regulatory agencies globally."
This second successful PAI (Pre-Approval Inspection) at the site in less than 6 months indicates steady progress in review of Indoco's pending ANDAs. The Company has 39 ANDAs, pending for approval from this site".
| Updated on: 25 - Nov - 2019
|
|
|
|