“ Domestic drug firms are facing a lot of regulatory issues in the US market with the US health regulator pulling them up for non-compliance of manufacturing norms.
Homegrown domestic drug firms including, Aurobindo Pharma, Cadila Healthcare, Ipca Labs are facing a lot of regulatory issues in the US market with the US health regulator pulling them up for noncompliance of manufacturing norms.
Hyderbad-based Aurobindo Pharma is recalling 24,816 bottles of Gabapentin capsules used as anticonvulsant and analgesic following complaints of empty capsules in the US market.
According to notification by the US Food and Drug Administration (USFDA), the Indian firm's arm Aurobindo Pharma USA Inc has initiated a Class II nation wide recall. Each bottle contains 100 capsules of 300 mg
The drug is manufactured by Aurobindo Pharma at its Mahabub Nagar facility in Andhra Pradesh. As per the US Food and Drug Administration (USFDA) a Class II recall is initiated in a situation under which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.
The reason for the recall, as per USFDA, was that "complaints of empty capsules received".
In another development, a total of 64,719 bottles of different strengths of the same capsule manufactured by Actavis Pharma Manufacturing Pvt Ltd at Kanchipuram facility were being recalled in Puerto Rico.
The capsules were distributed by Actavis Elizabeth LLC and were being recalled following several complaints, including clumping and breaking of capsules and creased labels from one distribution centre.
Further, the US health regulator has issued import alert on drugs produced at Ipca Laboratories' Ratlam plant in Madhya Pradesh, following which the company has suspended shipment of active pharmaceutical ingredients to the American market.
“We now wish to inform you that US Food and Drug Administration (USFDA) has issued an import alert to the said manufacturing facility (Ratlam) on January 22, 2015," Ipca Laboratories said.
Consequently, the company has voluntarily decided to temporarily suspend API (active pharmaceutical ingredients) shipments from this manufacturing facility for the US markets till this issue is addressed, it added. PTI
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