Sun Pharma gets warning from FDA
What's the story
Sun Pharmaceutical received a warning letter from the US FDA as a result of a September 2014 inspection of the company's facility at Halol, Gujarat. Sun responded by saying that a robust remediation process was underway with significant investments in training and automation to enhance product quality. The company is expected to request a re-inspection by FDA upon completion of remediation procedures.
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Sun Pharmaceutical's scale of operations
After completing its acquisition of Ranbaxy for $3.2 billion in May 2015, Sun Pharmaceutical became the largest pharma company in India, the largest Indian pharma company in the US, and the 5th largest speciality generic company globally.
13 Mar 2014
FDA imposes import ban on Sun Pharma plant
The US Food and Drug Administration (FDA) imposed an import ban on Sun Pharmaceutical's facility at Karkhadi, Gujarat. It is suspected that the ban is a result of Sun Pharmaceuticals not following Current Good Manufacturing Practice (CGMP) regulations. A Sun Pharma spokeswoman said that the ban on the plant would have a 'negligible' financial impact and that the company had initiated 'several corrective steps'.
7 May 2014
FDA announces reason for import ban
In a letter dated 7th May 2014, the US FDA revealed its reason for banning imports from Sun Pharma's Karkhadi plant. The FDA regulator said that Sun Pharma's manufacturing staff had inadequate experience and the company failed to ensure laboratory records had complete data. "Your firm frequently performs 'unofficial testing' of samples, disregards the results, and reports results from additional tests," the letter read.
7 May 2014
The implications of Sun's inaccurate data
In the FDA's letter to Sun Pharmaceutical on 7th May 2014, serious concerns were raised about Sun's integrity of data. "The above examples suggest a general lack of reliability and accuracy of data generated by your firm's laboratory...raises concerns about the integrity of all data generated by your firm," the letter read. It was a serious issue which could result in charges of fraud.
20 May 2014
FDA continues ban after reinspection
The US Food and Drug Administration (FDA) re-inspected Sun Pharmaceutical Industries Ltd.'s Karkhadi plant in Gujarat. The FDA decided to continue the import ban, imposed in March 2014, on the Karkhadi plant, saying, "We have conducted a detailed review of your firm's initial response and note that it lacks sufficient corrective actions." Sun Pharmaceutical could not be reached for comments.
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Halol products recalled
Sun Pharmaceutical recalled 40,000 bottles of Venlafaxine Hydrochloride tablets after it failed the dissolution test. It also recalled Gemcitabine for manufacturing issues and Metformin for packaging problems. All three products were manufactured at the Halol plant in Gujarat.
11 Sep 2014
FDA pays surprise visit to Sun's Halol plant
The US Food and Drug Administration (FDA) conducted a surprise inspection of Sun Pharmaceutical's manufacturing facility at Halol, Gujarat. The inspection may have been precipitated by the fact that 3 products manufactured at Halol had recently been recalled by Sun from the US market. Sun Pharma refused to comment on the inspection. The facility contributes around 40% of Sun Pharma's US sales.
27 Sep 2014
Halol plant gets relief from US FDA
The US FDA team which conducted the inspection of the Halol plant submitted a Form 483 implying that the FDA found certain procedural lapses at the plant and would seek corrective action from Sun Pharmaceutical. However, to Sun Pharma's relief, the plant had 'no data integrity issues', which implied that chances of an import ban being imposed on the plant were 'low'.