Tuesday, Jul 05, 2022
Outlook.com

Zydus to supply product to US firm Sagent from Gujarat plant

Zydus said it has received approval from the US Food and Drug Administration, which allows for a site transfer and manufacturing of the drug at Jarod.

Representative image
Representative image

Zydus Lifesciences on Wednesday said it will supply Caffeine Citrate Oral Solution from its Gujarat-based manufacturing plant to Sagent Pharmaceuticals.

The company will be manufacturing and supplying Caffeine Citrate Oral Solution in the strengths of 60 mg per 3 ml (20 mg per ml) single-dose vial from its injectables facility at Jarod in Gujarat,  Zydus Lifesciences said in a statement.

Zydus said it has received Prior Approval Supplement (PAS) approval from the US Food and Drug Administration (USFDA), which allows for a site transfer and manufacturing of the drug at Jarod.

Caffeine Citrate Oral Solution is indicated for short-term treatment of a breathing problem (Apnea) in premature infants. Caffeine blocks certain proteins (adenosine receptors) which leads to improved breathing in infants suffering from Apnea.

The US-based Sagent Pharmaceuticals is a pharmaceutical company focused on developing, manufacturing, sourcing, and marketing pharmaceutical products for the North American market, with a specific emphasis on injectables.

PAS is an application that seeks to make changes to an already approved application, such as an Abbreviated New Drug Application (ANDA), which is used by the USFDA to approve generic drugs.

Advertisement
Advertisement
Advertisement