Pharma firm Indoco Remedies said its international business prospects are looking up and its business from US is expected to grow, once the issues related to warning letter are resolved.
"The company has filed 32 ANDAs pending for approval, including first-to-file (FTF's)and Para IV applications. Going forward, the company's business from US is expected to grow, once the issues related to warning letter is resolved," Indoco Remedies Chairman Suresh G Kare said at the company's annual general meeting (AGM).
"The USFDA inspected facilities at Goa (Plant II & III) during August-September last year. As an outcome of this inspection, the facility received 6 observations in Form 483, none of which pertain to data integrity.
"However, USFDA has issued warning letter with respect to ophthalmic product leakage. The company has given a detailed response to USFDA's warning letter and is hopeful to tide over this matter at the earliest, with the help of a US based consultant," Kare said.
International business prospects are also looking up. During FY 17, the company received USFDA approval for Allopurinol 100 mg and 300 mg tablets. AnaCipher CRO was audited by USFDA twice during January and February this year and both these audits were successful, with zero 483s, he added.
In 2016-17, the company has achieved a top line growth of 8.8 per cent despite the challenges, largely caused by headwinds on account of government policies in the Indian market and regulatory issues in the international market.
The company also said it has completed the integration of recently acquired manufacturing facility at Baddi.
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