Anthem Biosciences, the seven-year-old biopharmaceutical company has been cleared by the US FDA audit at the first go. The effort is a booster shot for the company to garner much of the growth ensuing from the contract and research and manufacture service (CRAMs) business for its internationally audited facility.
The audit took place early this month on October 7, 2013. The facility was approved for all the three small volume generics which were cleared without any 483 observations indicating complete compliance to US FDA norms, Ajay Bharadwaj, CEO, Anthem Biosciences Pvt. Ltd. told Pharmabiz.
“We have been audited and approved by many clients and Qualified Persons (QPs) from Europe. However from the US FDA, this is our maiden inspection,” he added.
Post inspection of the facility, the company was informed by the US FDA inspectorate team on the endorsement for approval of all three small volume generics which Anthem had filed because there were absolutely no 483s observations. Further, the US FDA inspectorate viewed the facility as one of the best production pilot plants audited so far in the start-up company category in India, said Dr Ganesh Sambasivam, co-founder and chief scientific officer, Anthem Biosciences.
The company has an exclusive arrangement with a US leading generic company to supply three active pharmaceutical ingredients (APIs). “It took about two years from the project initiation till the inspection. Earlier capacity was of pilot scale of few 100s of kilos. Now we have expanded the facility, designed it in line with cGMP requirements, with bigger reactors and can handle tonnage production,” Dr Ganesh added.
Details of the three small volume generics manufactured on exclusivity basis at its facility in the Bommasandra Industrial Area, Bengaluru were not disclosed.
“We are working with many big pharma and leading biotech companies globally to develop technologies from the early stages. This led to augment manufacturing capacities and seek regulatory approvals. Now we have cleared the first hurdle and going forward we would expand in this business vertical. We want to be one of the leading manufacturers of products to regulated market,” said Dr Sambasivam.
Since its inception in 2006, Anthem known for its DRAP (discovery research alliance partnership) for biology and chemistry has now transformed into a Contract Research and Innovation Service Provider (CRSP). It developed novel platform technologies and filed for global patents. The company sees these innovations as unique tools for discovery. Its subsidiary Cellutions handles only bulk actives for enzymes, nutraceuticals, dietary supplements and food additives and has filed for patents. The CRAMS business is a key revenue driver and Anthem has been maximizing the opportunities from US and Europe besides scout for potential avenues in Japan.
There is also a Greenfield project for manufacturing facility at Kanakapura in Bengaluru Rural where Anthem is investing around Rs.100 crore. The construction has commenced and commissioning of operations will start in about 18 months time, said Ravindra Chandrappa, chief operating officer, Anthem Biosciences.