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US and EU enter Mutual Recognition Agreement for drug manufacturing inspections europeanpharmaceuticalreview
July 17, 2019
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
FDA Inspection of Asymchem Dunhua 1 API Manufacturing Facility is Successful contractpharma
June 12, 2019
No 483s were issued.
USFDA concludes inspection of Indoco’s Sterile facility (Plant II) expressbpd
June 06, 2019
The US health regulator made four observations on the pharma company’s Goa plant
Dalton Pharma Services Completes PAI Inspection contractpharma
May 16, 2019
Paves way for Dalton to manufacture commercial API products for U.S. distribution.
Swissfillon Completes Successful FDA Inspection contractpharma
May 16, 2019
The production site in Visp was assessed by FDA between April 15 and 24.
WuXi STA's New Drug Product Manufacturing Facility Passes First European MPA GMP Inspection en-cphi.cn
March 28, 2019
A subsidiary of WuXi AppTec - announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the European Medical Products Agency (MPA).
USFDA concludes inspection of Unichem Lab’s Ghaziabad facility expressbpd
March 12, 2019
The inspection was successfully conducted from March 3-8, 2019, without any USFDA form 483 being issued
US FDA completes inspection of Lupin’s Pithampur Unit-2 (Indore) facility expressbpd
February 12, 2019
The inspection was carried out between January 14 and January 25, 2019
US FDA completes inspection of Lupin’s Mandideep location expressbpd
December 07, 2018
The Mandideep location houses the company’s cardiovascular “Pril” API facilities, Cephalosporin API facilities and Cephalosporin Solid Oral Dosage Form facility
Lupin’s Nagpur facility inspection concludes with no observation financialexpress
September 17, 2018
This inspection was a product specific pre-approval inspection

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