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  • form 483

Tag: form 483

You Searched For "form 483"
Dr Reddys Launches Generic Bridion Injection in US

Dr Reddy's Receives 3 USFDA Observations at Srikakulam Facility

Written By sheeba farhat30 July 2026 9:53 PM IST
New Delhi: Dr. Reddy's Laboratories has informed stock exchanges that the United States Food and Drug Administration (USFDA) has completed a...
USFDA Approves Ciplas Generic Advair Diskus for Asthma, COPD

Cipla Gets 1 USFDA Observation for New York Pharma Plant

Written By Parthika Patel18 July 2026 4:57 PM IST
Mumbai: Drug major Cipla Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a routine...
Aurobindo Pharma Acquires 26% Stake in Solar Firm, Executes Captive Power Agreement

USFDA Concludes Inspection of Aurobindo Pharma Subsidiary with 2 Observations

Written By Parthika Patel30 Jun 2026 5:54 PM IST
New Delhi: Aurobindo Pharma Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed an...
Dr Reddys Gets 7 USFDA Observations for Bachupally Biologics Plant

Dr Reddy's Gets 7 USFDA Observations for Bachupally Biologics Plant

Written By Parthika Patel27 Jun 2026 8:25 PM IST
New Delhi: Dr. Reddy's Laboratories Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed...
Aurobindo Pharma Acquires 26% Stake in Solar Firm, Executes Captive Power Agreement

Aurobindo's Eugia Steriles Gets 5 USFDA Observations After Pre-Approval Inspection

Written By Parthika Patel20 Jun 2026 9:39 PM IST
Hyderabad: Aurobindo Pharma Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a...
Jubilant Pharmova Receives 8 USFDA Observations for Spokane Facility

Jubilant Pharmova Receives 8 USFDA Observations for Spokane Facility

Written By Farhat Nasim19 Jun 2026 12:00 PM IST
New Delhi: Jubilant Pharmova Limited has announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at the...
Granules Secures Sole First-to-File Status for Generic Narcolepsy Drug LUMRYZ in US

Granules Gets 4 USFDA Observations for US Facility

Written By sheeba farhat3 Jun 2026 7:38 PM IST
New Delhi: Granules India Limited has announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), located in Chantilly,...
Shilpa Medicares Bengaluru Unit Receives 5 USFDA Observations Following PAI

Shilpa Medicare's Bengaluru Unit Receives 5 USFDA Observations Following PAI

Written By Parthika Patel1 Jun 2026 11:36 PM IST
Hyderabad: Shilpa Medicare Limited has announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI)...
Strides Pharma Divests Majority Stake in Pivot Path to Ascent Capital-Led Investors in Rs 100 Crore Deal

Strides Pharma Bengaluru Facility Receives Form 483 with 5 USFDA Observations

Written By Parthika Patel21 May 2026 11:45 AM IST
New Delhi: Strides Pharma Science has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has issued a Form 483...
Emcures Poviztra Cleared for Fatty Liver Treatment Following CDSCO Nod to Wegovy

Emcure Ahmedabad Unit Under USFDA Scanner, Gets 7 Procedural Observations

Written By Parthika Patel18 May 2026 11:43 PM IST
New Delhi: Emcure Pharmaceuticals has informed the stock exchanges that the United States Food and Drug Administration (USFDA) conducted a current...
Piramal Pharma Gets 3 USFDA Observations at US Facility

Piramal Pharma Gets 3 USFDA Observations at US Facility

Written By Parthika Patel12 May 2026 9:25 PM IST
New Delhi: Piramal Pharma Limited has informed stock exchanges that the United States Food and Drug Administration (US FDA) conducted a Good...
USFDA Flags Compliance Gaps at Alkems Daman Plant, Issues 7 Observations

USFDA Flags Compliance Gaps at Alkem's Daman Plant, Issues 7 Observations

Written By Parthika Patel4 May 2026 11:30 PM IST
New Delhi: Alkem Laboratories Limited has received seven observations in a Form 483 issued by the US Food and Drug Administration (USFDA) following an...
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