The biopharma world's manufacturing weekly

Endpoints Manufacturing

Manufacturing channel feed

FDA in­spec­tion at Catal­ent’s Bel­gium fa­cil­i­ty un­cov­ers da­ta, equip­ment and oth­er QC is­sues

3 years ago
Pharma
FDA+

Pfiz­er to make an al­most $1B in­vest­ment in its Dublin man­u­fac­tur­ing fa­cil­i­ty — re­port

3 years ago
Pharma

Roche is­sues vol­un­tary re­call for Susvi­mo over man­u­fac­tur­ing is­sue

3 years ago
Pharma

Up­dat­ed: With new $100M in­vest­ment, a biotech with two ap­proved drugs spins out its man­u­fac­tur­ing busi­ness

3 years ago
Deals
R&D

Man­u­fac­tur­ing roundup: Hik­ma, Lil­ly US man­u­fac­tur­ing sites hit with 483s; GAO says HHS should ad­dress stock­pile risks

3 years ago

Sanofi sells Japan­ese man­u­fac­tur­ing site to CD­MO but main­tains sup­ply agree­ment

3 years ago

Charles Riv­er cuts the rib­bon on for­mer As­traZeneca site in the UK for plas­mid man­u­fac­tur­ing

3 years ago

Preap­proval and oth­er man­u­fac­tur­ing in­spec­tions: FDA re­vis­es two com­pli­ance guides

3 years ago
Pharma

New Tor­rent Phar­ma­ceu­ti­cals Form 483 high­lights clean­ing and oth­er qual­i­ty is­sues

3 years ago
Pharma
FDA+

Un­san­i­tary con­di­tions and oth­er QC is­sues raised by FDA in a warn­ing to con­tract pack­ager

3 years ago
Pharma
FDA+

Adder­all sup­ply woes con­tin­ue as the FDA con­firms short­age of im­me­di­ate re­lease cap­sules

3 years ago
Pharma

En­sur­ing con­sis­ten­cy in prod­uct qual­i­ty: How FDA's re­quests for more in­fo will be for­mal­ized

3 years ago
FDA+

Man­u­fac­tur­ing roundup: Lon­za to man­u­fac­ture two new FDA-ap­proved ther­a­pies in Hous­ton; Ei­sai fin­ish­es project in Japan

3 years ago

Lin­eage Cell Ther­a­peu­tics opens new Cal­i­for­nia R&D fa­cil­i­ty and ex­pands Is­rael man­u­fac­tur­ing site

3 years ago
Pharma
Cell/Gene Tx

Io­n­is to build new man­u­fac­tur­ing site in South­ern Cal­i­for­nia, dou­bling the size of its cur­rent site

3 years ago
Pharma

Amid a glob­al build­out, Cy­ti­va ac­quires a provider of vi­ral vec­tor man­u­fac­tur­ing tech­nolo­gies

3 years ago
Deals
Pharma

Ad­di­tion­al man­u­fac­tur­ers in short sup­ply of gener­ic Adder­all

3 years ago
Pharma

De­spite $109M in­flux in Au­gust, Green­Light Bio­sciences brings out the axe to chop a quar­ter of its staff

3 years ago
People
R&D

FDA set­tles drug com­pound­ing suit, agrees to speed its re­view of bulk in­gre­di­ents

3 years ago
FDA+

Am­neal lays off more than a dozen em­ploy­ees at Long Is­land fa­cil­i­ty as op­er­a­tions wind down

3 years ago

FDA re­veals QC is­sues at Eli Lil­ly’s man­u­fac­tur­ing site in New Jer­sey — re­port

3 years ago
FDA+

Af­ter rop­ing in $175M+ at the be­gin­ning of the year, Metageno­mi opens the doors to a new man­u­fac­tur­ing site

3 years ago

Gink­go inks $144M deal with Mer­ck to en­gi­neer en­zymes to im­prove in­gre­di­ent man­u­fac­tur­ing

3 years ago
Deals

Af­ter $10B in mar­ket val­ue lost, Chi­na's WuXi Bi­o­log­ics re­moved from US un­ver­i­fied list

3 years ago
China
Outsourcing
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