An In­di­an phar­ma with a man­u­fac­tur­ing site in Gu­jarat has been slapped with a Form 483 from the FDA af­ter in­spec­tions that end­ed yes­ter­day re­sult­ed in 10 ob­ser­va­tions.

The in­spec­tion was car­ried out from April 26 to May 9 at Sun Phar­ma’s Halol fa­cil­i­ty in Gu­jarat, and shares were down 3% fol­low­ing the re­lease of the news. The de­tails of the ob­ser­va­tions have not yet been re­vealed.

“The com­pa­ny is prepar­ing the re­sponse to the ob­ser­va­tions, which will be sub­mit­ted to the US FDA with­in 15 busi­ness days,” Sun Phar­ma said in a let­ter to the Na­tion­al Stock Ex­change of In­dia. “The com­pa­ny is com­mit­ted to ad­dress­ing these ob­ser­va­tions prompt­ly. The com­pa­ny re­mains com­mit­ted to work­ing close­ly with the US FDA and con­tin­ues to en­hance its GMP com­pli­ance on an on­go­ing ba­sis.”

An an­a­lyst told Busi­ness-Stan­dard that the site is re­spon­si­ble for rough­ly 5-6% of the com­pa­ny’s turnover and that the site has be­come small­er over the years.

Sun was forced to re­call 100,000 bot­tles of its gener­ic erec­tile dys­func­tion tablet back in Oc­to­ber. It al­so pulled more than 22,000 packs of ex­tend­ed-re­lease lo­rata­dine-D tablets. The site got hit with a Form 483 back in De­cem­ber 2019, when it was slapped with eight ob­ser­va­tions.

Just in March, the phar­ma was forced to pay a big set­tle­ment in lieu of claims of mis­con­duct against its Ran­baxy gener­ics unit. The phar­ma agreed to shell out $485 mil­lion to set­tle the class-ac­tion suit, with­out ad­mit­ting to the charges. Charges ac­cuse Ran­baxy of in­clud­ing false in­for­ma­tion in its ap­pli­ca­tions to make gener­ics of Genen­tech’s an­tivi­ral drug Val­cyte, No­var­tis’ Dio­van — which is used for blood pres­sure — and Nex­i­um, the acid re­flux drug from Pfiz­er. As a re­sult of the first ap­provals, the com­pa­ny gained 180 days of ex­clu­siv­i­ty on the mar­ket.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).