News | July 06, 2022
Cipla updates on US FDA product-specific pre-approval inspection
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
He will be responsible for ensuring that every dose of medication that ACG Inspection’s pharmaceutical and nutraceutical partners provide is manufactured and delivered exactly as intended
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms
The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product
The company does not expect the outcome of this inspection to impact its plans
The company said in a regulatory filing that it was confident of addressing the observations satisfactorily
The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection
Integrated eCOA technology and rater training aim to reduce variability and strengthen ClinRO outcomes
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