Message From the Top Management
The year witnessed upheavals on account of regulatory challenges and market dynamics. Consequently, the revenues of both India business and International business got impacted. This along with increase in the cost of operations, resulted in drop in the bottom line. However, the Company is adopting appropriate strategy to mitigate challenges in both the business segments.
On the positive side, the Company's concentrated efforts have paid off with withdrawal of the warning letter issued to Goa Plant II & III by the USFDA in March 2017 and the inspection classification status being changed from 'Official Action Indicated' (OAI) to 'Voluntary Action Indicated' (VAI). Subsequently, the US Food and Drug Administration (USFDA) conducted another audit at Indoco's sterile manufacturing facility in Verna, Goa (Plant II) from 27th May'19 to 4th June'19, issuing 4 observations (483s). This inspection was a scheduled PAI, i.e., Prior Approval Inspection for Injectable products, filed from this facility. We are hopeful for an early and successful closure of this audit.
The USFDA after its inspection of Goa Plant I (Finished Dosage facility) in January 2019, retained the Official Action Indicated (OAI) status. This however will not have an impact on sales to the US from this facility and the Company is confident of addressing the issues raised by USFDA.
The Company received approval from UKMHRA for its new solid dosage manufacturing facility in Baddi (III), Himachal Pradesh. We are now poised to garner additional business from Europe from the added capacity and licencing-out our own Marketing Authorizations. The Company has set up a 100% subsidiary in the Czech Republic to implement our growth strategy in Europe.
Indoco successfully commissioned its new API manufacturing facility at Patalganga and commercial production from this unit has commenced. The Plant received Certificate of Suitability (CEP) for new manufacturing process of Allopurinol from European Directorate of Quality of Medicine (EDQM) in May 2019, thus paving the way to commence supplies to European Markets from the new API site.
The Management is confident that post the regulatory challenges easing out and with key focus on growing brands in India business, growth in both these business segments will be healthier.
We express our gratitude to all our Stakeholders, including, shareholders, customers, bankers and the medical fraternity for their trust and support in Indoco. We thank all Indocoites for their contribution and trust, which we value the most.
Thanking you all,
Suresh G. Kare
Sundeep V. Bambolkar
Jt. Managing Director