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Aurobindo has received regulatory approval for — and is in the process of — acquiring pravastatin sodium tablets and the associated ANDA from Teva Pharmaceuticals. Everything will remain business as usual for the time being as Aurobindo works through the transition process which will proceed as follows:
Teva will continue supplying the product in its label and NDCs, so customers need not make any changes in ordering, remittance, or any other day-to-day activities for the product or Teva points of contact.
Teva and Aurobindo will be working on developing the necessary labeling and artwork changes, and once completed, Teva will begin contract manufacturing the product for Aurobindo in the latter's labels and NDCs.
In the meantime, Aurobindo will be in contact with customers, to ensure that everything is set up and ready to transition over to the Aurobindo product.
Once complete, it will make the transition from the Teva labels/NDCs to Aurobindo labels/NDCs and begin supplying the product from the Aurobindo distribution center.
From that point onwards, all ordering and remittance functions would be migrated over to Aurobindo’s system and points of contact team.
In parallel, Aurobindo will be doing a tech transfer to have the product produced at its large scale state-of-the-art Unit 4 finished goods facility.
For clarity and to make this a seamless transition, Teva will remain responsible for all product in the supply chain under its label/NDC in terms of chargebacks, returns, pharmacovigilance matters, etc. and Aurobindo will be exclusively responsible for all product marketed and sold under the Aurobindo label/NDC.
"Thank you as always for your continued support and partnership as we continue to deliver life improving and lifesaving medications to our mutual customers and patients," said Aurobindo USA Oral Solids division president Paul McMahon.
