The US Food and Drug Administration is expected to begin inspection of Sun Pharma's manufacturing facility at Halol in the second week of February, sources told ET. The much-awaited inspection is critical as the facility produces multiple medicines from tablets to ointments and injectables.
Following an inspection in the last week of November 2016, the Halol site was issued nine observations for deviations from standard manufacturing quality and procedure norms as spelled out by the US agency.
In a terse statement, a Sun Pharma spokesperson said it had no comments to offer.
A veteran in manufacturing related issues said generally a US FDA inspection is conducted with prior information to the company. A change in the schedule of planned inspections is not ruled out if the US FDA decides for an unannounced inspection, he noted. Earlier in September 2014, the Halol site came under the lens, receiving as many as 23 observations from the US agency. The inspection culminated into a warning letter fifteen months on in December 2015. The long delay on finding a resolution for the Halol site has consecutively impacted Sun Pharma's financial performance, aggravated further by a sharp drop in prices of key products that are sold in the US.
Its consolidated net profit dipped 59% for the September 2017 quarter to Rs 912 crore as compared to the same period in the previous year. Approvals for new products from the site is held back, dampening investor confidence. While Sun Pharma said it has completed the remediation exercise at Halol and requested a reinspection, the company also informed investors over the last earnings call that some of its drugs are being transferred to other sites.
The US FDA's observations during the 2016 inspection by investigators Patric Klotzbuecher and Santos Camara found lapses such as testing programs that were not adequately designed to assess the stability characteristics of the drugs, the accuracy of test methods had not been established and scientifically sound and appropriate laboratory control mechanisms were not established to assure drug products conform to appropriate standards of identity, strength, quality and purity. When fully operational, the Halol site had contributed as much as 15% of Sun Pharma's US revenues.
Located about 300 kms south of Halol, Sun Pharma's facility in Dadra had a better record on manufacturing compliance. After getting 11 observations in April 2017 as part of US FDA's inspections, the site was cleared by the agency four months later in October, bringing relief from uncertainties.
Following an inspection in the last week of November 2016, the Halol site was issued nine observations for deviations from standard manufacturing quality and procedure norms as spelled out by the US agency.
In a terse statement, a Sun Pharma spokesperson said it had no comments to offer.
A veteran in manufacturing related issues said generally a US FDA inspection is conducted with prior information to the company. A change in the schedule of planned inspections is not ruled out if the US FDA decides for an unannounced inspection, he noted. Earlier in September 2014, the Halol site came under the lens, receiving as many as 23 observations from the US agency. The inspection culminated into a warning letter fifteen months on in December 2015. The long delay on finding a resolution for the Halol site has consecutively impacted Sun Pharma's financial performance, aggravated further by a sharp drop in prices of key products that are sold in the US.
Its consolidated net profit dipped 59% for the September 2017 quarter to Rs 912 crore as compared to the same period in the previous year. Approvals for new products from the site is held back, dampening investor confidence. While Sun Pharma said it has completed the remediation exercise at Halol and requested a reinspection, the company also informed investors over the last earnings call that some of its drugs are being transferred to other sites.
The US FDA's observations during the 2016 inspection by investigators Patric Klotzbuecher and Santos Camara found lapses such as testing programs that were not adequately designed to assess the stability characteristics of the drugs, the accuracy of test methods had not been established and scientifically sound and appropriate laboratory control mechanisms were not established to assure drug products conform to appropriate standards of identity, strength, quality and purity. When fully operational, the Halol site had contributed as much as 15% of Sun Pharma's US revenues.
Located about 300 kms south of Halol, Sun Pharma's facility in Dadra had a better record on manufacturing compliance. After getting 11 observations in April 2017 as part of US FDA's inspections, the site was cleared by the agency four months later in October, bringing relief from uncertainties.