Sun Pharma said, "It (SPARC) is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XRTM."
But, in September 2015, SPARC secured a complete response letter (CRL) from the USFDA that rescinded its earlier approval, saying that the compliance status of the production plant at Halol site of Sun Pharma was not acceptable on the date of approval.
Sun Pharma has implemented a complete remediation at Halol to restore current good manufacturing practices (cGMP) compliance status for the site.
Mike Lanning, a founder director of Viridian Pharma
, added Through the successful collaboration on our caffeine citrate range, Martindale Pharma
has demonstrated the capability to ensure these important medicines are preferentially used in vulnerable patients.
The acquired Portfolio is expected to add more than $237 million to Mayne Pharmas FY17 net sales with gross margins greater than 50 percent.
Mayne Pharma will fund the acquisition via a fully underwritten equity raising on the Australian Securities Exchange (ASX) and an extension of Mayne Pharmas existing debt facilities secured in June 2015.
Mayne Pharma Group Limited (Mayne Pharma) has entered into an agreement to acquire 37 approved and 5 FDA filed products from Teva Pharmaceutical Industries Limited (Teva) and Allergan plc (Allergan) for cash consideration of $652 million.
Stefan Cross, president of Mayne Pharma USA, said, "We are extremely pleased to complete this transaction that establishes Mayne Pharma as a key player in the U.S.
He added, "Our expanded product offering from the Teva/Allergan acquisition provides Mayne Pharma with an opportunity to deepen relationships across the industry with patients and customers and continuing through to our contract manufacturing and active pharmaceutical ingredient partners.