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USFDA issues four minor observations to JB Chemicals’ Gujarat facility

US Food and Drug Administration (USFDA) has issued four minor observations to JB Chemicals & Pharmaceuticals’ solid oral manufacturing facility at Panoli, Gujarat. The company proposes to address these observations within next 15 days. These observations will not have any impact on the current business and will facilitate ANDA of ... Read More »

Zydus Cadila receives approval from USFDA for Colchicine Tablets

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Colchicine Tablets USP (US RLD – ColcyrsTM), 0.6 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to prevent or treat attacks of gout (also ... Read More »

Zydus Cadila gets final approval from USFDA for Exemesfane Tablets

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA)  to market Exemestane Tablets, (US RLD – AROMASIN Tablets), 25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The estimated sale for Exemestane Tablets is $68.6 million. Exemestane belongs ... Read More »

Vivimed Labs’ API manufacturing facility gets EIR from USFDA

Vivimed Labs’ API manufacturing facility located in Cuernavaca, Mexico has been inspected by the US Food and Drug Administration (USFDA). The inspection was successful and company obtained Establishment Inspection Report (EIR). This was a routine inspection by the USFDA. Vivimed Labs is engaged in providing specialty chemicals and pharmaceuticals products. ... Read More »

Cadila Healthcare’s Biologics manufacturing facility gets EIR from USFDA

Cadila Healthcare’s Biologics manufacturing facility (Zydus Biologics) located at Ahmedabad has received an Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) signifying the successful closure of the audit from August 14 to August 24, 2018, with zero 483 observations. Cadila Healthcare is an India-based pharmaceutical company. The ... Read More »