Manufacturer – Talk Bio

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Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

2 months ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

FDA Issues Complete Response Letter to Camurus for Acromegaly Treatment Due to Third-Party Manufacturing Deficiencies

1 year ago talkbio0Tagged Acromegaly, Camurus, Complete, Manufacturer, Response process, United States Food and Drug Administration

FDA, Camurus, Complete Response Letter, Acromegaly, Manufacturing Issues, Third-Party Manufacturer, CAM2029