Strides Arcolab gets USFDA approval for its Bangalore facility
27 Mar 2009
Strides Arcolab has received inspection approval from the US Food and Drugs Administration (USFDA) for its sterile complex at Bilekahalli in Bangalore to be current good manufacturing practices (cGMP) compliant.
''A zero 483 approval for compliance in a challenging manufacturing and regulatory environment the pharma industry is currently facing is indeed a landmark,'' Venkat Iyer, CEO of India operations of the US company said in a filing with the Bombay Stock Exchange (BSE).
''With over 100 sterile products (including filing guidance of 40 in 2009) and strong manufacturing investments completed we are confident of emerging as a global player in this niche segment,'' he said.
The company's sterile complex has three dedicated blocks for manufacturing penicillin and cephalosporin, injectables in dry powder, liquid vials, prefilled syringes and lyophilised product.
Strides manufactures pharmaceutical formulations in various dosage forms, including sterile injectables with dedicated facilities for penicillin and penems, cephalosporins, oncolytics and lyophilised injectable products. The company also manufactures pharmaceutical formulations in oral dosage forms, including capsules and tablets and softgel capsules.
Strides has a significant presence in Australasia, Africa and India and through a series of strategies is expanding its North American and European growth. The company has a series of joint ventures and front-ended operations in major markets and is a majority stakeholder of Ascent Pharmahealth Limited (APH), an ASX listed company.
The company also collaborates with Global Drug Agencies and US PEPEFAR and the UNICEF to supply a range of affordable generic pharmaceutical products used in the treatment of HIV, TB and malaria.
Strides has manufacturing facilities in Bangalore in India and in Milan, Warsaw, Singapore and Lagos overseas. The Indian manufacturing facilities are approved by all major regulatory bodies. Strides employs approximately 2,500 people across the globe. Strides also has a marketing presence in over 50 countries.
Strides, a global pharmaceutical company, listed on the Bombay Stock Exchange and the National Stock Exchange, has its Indian headquarters in Bangalore.