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KVK Tech, Inc.

https://www.kvktech.com/

Latest From KVK Tech, Inc.

‘Shadow’ Factory Challenges Continue For US FDA

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.

OTC Drugs Warning Letters

US FDA Seeks More Power To Confront ‘Shadow’ Factory Challenges

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find manufacturer of contaminated eye drops that disappeared.

Supply Chain Quality

KVK Research Pleads Guilty To Adulterated Drug Distribution

KVK Research and KVK Tech failed to notify the US FDA about the use of a foreign API manufacturing facility and submitted alleged false claims to governmental health programs.

Compliance Generic Drugs

US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain

Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

Review Pathway Drug Review
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