 "Claris' sale plan may hit roadblock as USFDA slams form 483 to its facility")
Ahmedabad-based injectables manufacturer Claris Lifesciences’ plans to sell its generic sterile injectables business might hit a block as its site here has recently received an adverse observation letter from the US Food and Drug Administration (FDA). Despite repeated attempts, the company could not be reached for a comment.
According to a report by a leading brokerage, which claims to have a copy of the letter, Claris has a single FDA-approved site that makes injectables.
“This site underwent FDA inspection between May 4 and 11. The facility has received a 483 observation letter, from USFDA containing five observations,” said the report.
The company has three manufacturing facilities at a site near the city.
The report adds these observations relate to insufficient procedures, lacunae in sampling, inadequate training and design deficiencies.
Form 483s are inspectional observations noticed during an inspection visit or audit of a manufacturing unit, explained a pharma analyst, adding, “however strongly worded these letters might be, they do not imply a final verdict determining the compliance of the unit. If a firm takes prompt action and is able to resolve issues to the satisfaction of the FDA, no further complications occur.”
However, in case the concerns over safety or efficacy persist, a warning letter may be issued.
It has been learnt that Claris Lifesciences is planning to sell the generic injectables business, and several companies are in fray to acquire the business. Industry insiders feel that the USFDA observations may push the prospective buyers to reconsider their stand. According to media reports, companies like Lupin, Cadila Healthcare and Amneal Pharma are interested in Claris. Cadila Healthcare, considered the front runner in the race, however, could not be reached for a comment.
According to a report by a leading brokerage, which claims to have a copy of the letter, Claris has a single FDA-approved site that makes injectables.
“This site underwent FDA inspection between May 4 and 11. The facility has received a 483 observation letter, from USFDA containing five observations,” said the report.
The company has three manufacturing facilities at a site near the city.
The report adds these observations relate to insufficient procedures, lacunae in sampling, inadequate training and design deficiencies.
Form 483s are inspectional observations noticed during an inspection visit or audit of a manufacturing unit, explained a pharma analyst, adding, “however strongly worded these letters might be, they do not imply a final verdict determining the compliance of the unit. If a firm takes prompt action and is able to resolve issues to the satisfaction of the FDA, no further complications occur.”
However, in case the concerns over safety or efficacy persist, a warning letter may be issued.
It has been learnt that Claris Lifesciences is planning to sell the generic injectables business, and several companies are in fray to acquire the business. Industry insiders feel that the USFDA observations may push the prospective buyers to reconsider their stand. According to media reports, companies like Lupin, Cadila Healthcare and Amneal Pharma are interested in Claris. Cadila Healthcare, considered the front runner in the race, however, could not be reached for a comment.
The US watchdog has been stringent about compliance issues with Indian manufacturing sites, which accounts for about 40 per cent of the total generic drugs in the US (in volume terms). Companies like Sun Pharma, Wockhardt, Dr. Reddy's have received form 483s in recent months for their facilities across the country.
Claris Lifesciences itself has received a warning letter from the USFDA banning the company from selling is products in the US in 2010, which it finally resolved in August 2012 when USFDA lifted the ban.
Earlier in July last year, a USFDA inspection had found the company's finished dosage and active pharmaceutical ingredients (API) as acceptable. In a filing to the Bombay Stock Exchange (BSE), Claris had said, “The company has received a report from US Food and Drug Administration (FDA) for the inspection it conducted classifying the finished dosage plant and the active pharma ingredients (API) plant as acceptable."
The company's shares, however, tanked 2.55 per cent to Rs 267 a share.