It was observed that the drug firm had not satisfactorily obtained from the central government the required approvals for the laboratory operations. As decided by the drug regulator, no further drug applications would be accepted from the company. Also, the drug applications that the company had already filed from the Mumbai laboratory in discussion would not be processed until the company obtains requisite approvals for the lab.
The company confirmed of having received a letter from DCGI regarding this matter. The company assured that the necessary steps are being taken and they remain confident that the issue will soon be resolved. The company believes that they have complied with the necessary regulatory requirements and it is possibly due to the ambiguity in guidelines that has caused this issue. IGMPI. CCI Newswire
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