An In­dia-based gener­ics man­u­fac­tur­er is once again feel­ing the wrath of US reg­u­la­tors.

Au­robindo Phar­ma has been slapped with a Form 483 fol­low­ing an in­spec­tion of the com­pa­ny’s oral man­u­fac­tur­ing fa­cil­i­ty, the com­pa­ny an­nounced in a let­ter, while keep­ing the de­tails to a min­i­mum.

The fa­cil­i­ty is lo­cat­ed in Jad­cher­la, In­dia, out­side of the city of Hy­der­abad. The in­spec­tion be­gan last week, and con­clud­ed on Tues­day, ac­cord­ing to Au­robindo. The FDA not­ed six ob­ser­va­tions, though it’s still un­clear ex­act­ly what went wrong.

Form 483 is is­sued when in­spec­tors ob­served “any con­di­tions that in their judg­ment may con­sti­tute vi­o­la­tions of the Food Drug and Cos­met­ic (FD&C) Act and re­lat­ed Acts,” ac­cord­ing to the FDA.

“The Com­pa­ny will re­spond to the US FDA with­in the stip­u­lat­ed time­line and work close­ly with US FDA to close the ob­ser­va­tions,” Au­robindo said in the let­ter.

The in­spec­tion is cer­tain­ly not help­ing Au­robindo’s stock price $AU­ROPHAR­MA which fell over 2% to­day and has dropped more than 20% in the past year.

How­ev­er, this is not the first time the com­pa­ny has found it­self in the FDA’s crosshairs. The com­pa­ny has re­ceived 14 oth­er 483 forms for dif­fer­ent man­u­fac­tur­ing sites in Telan­gana state since 2016.

In April of this year, FDA in­spec­tors closed Au­robindo’s Day­ton, New Jer­sey site, elim­i­nat­ing 99 jobs in the process. The site re­ceived a ma­jor warn­ing let­ter in 2020, re­veal­ing that the com­pa­ny’s staff had failed to in­ves­ti­gate un­ex­plained dis­crep­an­cies or fail­ures in API batch­es and left wa­ter leaks in pack­ing rooms, where am­bi­ent mois­ture can po­ten­tial­ly con­t­a­m­i­nate APIs. The com­pa­ny was al­so ac­cused of fail­ing to iden­ti­fy im­pu­ri­ty re­sults from con­t­a­m­i­na­tion due to mor­tar.

Au­robindo’s prod­ucts have al­so been the tar­get of sev­er­al FDA re­calls. Back in Feb­ru­ary, the com­pa­ny had to re­call more than 1.15 mil­lion bot­tles of Mox­i­floxacin Oph­thalmic So­lu­tion — an an­tibi­ot­ic used to treat eye in­fec­tions like bac­te­r­i­al con­junc­tivi­tis — due to failed im­pu­ri­ties and degra­da­tion spec­i­fi­ca­tions, ac­cord­ing to The Eco­nom­ic Times.  And in Jan­u­ary, Au­robindo vol­un­tar­i­ly re­called a lot of polymyx­in B for in­jec­tion af­ter a hair was found in a vial with­in the lot. That an­tibi­ot­ic is used to treat menin­gi­tis, pneu­mo­nia, sep­sis, and uri­nary tract in­fec­tions.

The FDA al­so is­sued a warn­ing let­ter to the com­pa­ny in Jan­u­ary for an­oth­er drug man­u­fac­tur­ing fa­cil­i­ty in Telan­gana state in con­nec­tion with a pre­vi­ous in­spec­tion. The let­ter cit­ed de­vi­a­tions from cur­rent good man­u­fac­tur­ing prac­tices for API.

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.