11.20.18
Piramal Pharma Solutions (PPS) has completed its new cGMP kilo lab suite at its active pharmaceutical ingredient (API) site in Ennore, Chennai, India. The suite will formally open on December 1, 2018. Ennore is a key API site in the PPS integrated site network, with capabilities from early development through commercial manufacturing, with an available capacity of over 300kL. The site supplies key starting materials, registered starting materials, advanced intermediates and APIs for both large pharma and biotech firms, in North America, Europe, and RoW markets.
According to the company, the cGMP kilo lab facility at Ennore will bridge the gap between discovery and early clinical development, addressing the needs of several discovery customers that want to rapidly advance their programs into the clinic. The facility operates in an ISO-8 certified clean room environment, with single fluid utility systems, supports temperatures ranging from -90°C to 200°C, and can handle batch sizes of up to 15 kg. Subsequent development and manufacturing of APIs as the programs advance can be carried out at the Piramal sites in Riverview (U.S.), Aurora (Canada), Digwal (India), in addition to Ennore.
"Ennore continues to grow in terms of customer interest,” said Vivek Sharma, chief executive officer, Piramal Pharma Solutions. “Recently, we have seen an increase in demand for stand-alone early cGMP development projects, further augmented by requests from our discovery customers, to support early clinical development API supply from India. By adding this new cGMP kilo lab, we can now supply Phase I clinical requirements through several Piramal sites including Ennore, Riverview and Aurora.”
According to the company, the cGMP kilo lab facility at Ennore will bridge the gap between discovery and early clinical development, addressing the needs of several discovery customers that want to rapidly advance their programs into the clinic. The facility operates in an ISO-8 certified clean room environment, with single fluid utility systems, supports temperatures ranging from -90°C to 200°C, and can handle batch sizes of up to 15 kg. Subsequent development and manufacturing of APIs as the programs advance can be carried out at the Piramal sites in Riverview (U.S.), Aurora (Canada), Digwal (India), in addition to Ennore.
"Ennore continues to grow in terms of customer interest,” said Vivek Sharma, chief executive officer, Piramal Pharma Solutions. “Recently, we have seen an increase in demand for stand-alone early cGMP development projects, further augmented by requests from our discovery customers, to support early clinical development API supply from India. By adding this new cGMP kilo lab, we can now supply Phase I clinical requirements through several Piramal sites including Ennore, Riverview and Aurora.”
