A view of the SSCL Alathur exterior.
After an intense two-day inspection by the Centre for Drug Evaluation and Research-United States Food and Drug Administration (CDER-USFDA), on 18 and 19, November 2002, Dr Mike Gavini, Compliance Officer, CDER-USFDA, announced that the facility of Sanmar Speciality Chemicals (SSCL) at Alathur, had passed the inspection without any reportable non-compliance under Form 483. CDER-
A view of the interior.
USFDA approves new drugs including new molecular entities with ingredients never before marketed in the US.
SSCL is marching towards becoming a key global player in the Active Pharmaceutical Ingredients (APIs) business. Passing the USFDA inspection is a major achievement and this was made possible
The team that made it possible!
by the concerted efforts of the team at Alathur.
The manufacturing and testing facilities were upgraded to meet international standards. The systems demonstrated compliance with current Good Manufacturing Practices. SSCL is already certified to ISO-9001:2000.