Kemwell Biopharma, a global bio-pharmaceutical contract development and manufacturing company, announced that its oral solids manufacturing facility located in Bangalore, has been successful completed a US FDA inspection.
The inspection confirmed the site to be compliant with principles of cGMP and no Form 483 observations were issued. The audit was triggered by an ANDA filed for a customer. This facility is part of Kemwell’s pharmaceutical business for which the company has signed a purchase agreement with Recipharm.
“We are proud of the result achieved during the FDA inspection. In the last 10 years we have successfully faced 3 US FDA and 3 EMA inspections. This success is testament to our on-going commitment towards our quality systems, stated Anurag Bagaria, chairman, Kemwell.
“We are now preparing for our first Japanese inspection in the same facility and our first EMA/FDA inspection in our biotech facilities,” he added.
Kemwell will continue to leverage its 30-year experiences in being a leading contract development and manufacturing service provider to provide services in the biotech space. Its biotech facilities are the largest contract manufacturing facilities in India. With 2 x 2000 L of cGMP cell culture capacity along with process development and drug product manufacturing for liquid and lyophilized vials, Kemwell is an end-to-end service provider for mAbs and therapeutic proteins.
The company provides customized product development and cGMP compliant manufacturing solutions to pharmaceutical and biopharmaceutical organizations worldwide. It delivers a full product portfolio of services for sterile and non-sterile products from pre-formulation to commercial supply. The facilities have been inspected by US FDA, EMA, ANVISA and other health authorities. The 37-year-old company employs 1,200 workforce in India.