| 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-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 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. |
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| A view of the SSCL Alathur exterior. |
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| A view of the interior. |
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| The team that made it possible! |
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