Register entry

Boehringer Ingelheim Biopharmaceuticals China Ltd

Data as of · How to read this entry

Registered sites
3
Active NDC listings
127
Labeller names
4
Live patents
551
Exclusivities
9
Countries
2
Base
Germany
Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture3Labelling3Finished drug manufacture3Packaging3
Sites

Registered establishments

3
EstablishmentAddressRegistered forFEI / DUNS
Boehringer Ingelheim Biopharmaceuticals (China) Ltd. (Branch Plant)Registrant: Boehringer Ingelheim Biopharmaceuticals China Ltd257, Lishizhen Road, Pilot Free Trade Zone, Shanghai, -Select State- 201203, China (CHN)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3015009021699374574
Boehringer Ingelheim Pharma GmbH and Co. KGBirkendorfer Strasse 65, Biberach an der Riss, 88397, Germany (DEU)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3002806518340700520
Boehringer Ingelheim Pharma GmbH and Co. KGBinger Strasse 173, Ingelheim am Rhein, Rhineland-Palatinate 55216, Germany (DEU)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3002806556551147440
Catalogue

Drug listings by form and route

127

127 active NDC listings: 65 human prescription drug, 32 drug for further processing, 30 bulk ingredient. By marketing category: NDA 49, DRUG FOR FURTHER PROCESSING 32, BULK INGREDIENT 30, BLA 16.

Dosage formNDCs
powder21
solution18
tablet18
tablet, film coated14
kit12
liquid8
tablet, extended release8
pellet7
capsule6
spray, metered5
injection4
powder, for solution2
tablet, film coated, extended release2
aerosol, metered1
granule1
RouteNDCs
oral43
respiratory (inhalation)7
intravenous4
Labeller name on the listingNDCs
boehringer ingelheim pharmaceuticals, inc.62
boehringer ingelheim pharma gmbh and co. kg60
boehringer ingelheim pharmaceuticals inc.3
boehringer ingelheim biopharmaceuticals (china) ltd.2
Exclusivity

Patents and exclusivities

551
PatentProductCoversExpiry
9539258GILOTRIFafatinib dimaleateuseNov 2026
12171739HERNEXEOSzongertinibsubstance, productNov 2026
7727984STIOLTO RESPIMAT, STRIVERDI RESPIMATolodaterol hydrochloride; olodaterol hydrochloride; tiotropium bromidesubstanceJan 2027
7396341*PEDSPIRIVA RESPIMAT, STIOLTO RESPIMATolodaterol hydrochloride; tiotropium bromide; tiotropium bromideuseApr 2027
7713938GLYXAMBI, JARDIANCE, SYNJARDY, SYNJARDY XR, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochloride; empagliflozin; metformin hydrochloridesubstance, productApr 2027
11033552GLYXAMBI, TRADJENTAempagliflozin; linagliptin; linagliptinproductMay 2027
12178819GLYXAMBI, TRADJENTAempagliflozin; linagliptin; linagliptinproductMay 2027
9539258*PEDGILOTRIFafatinib dimaleateuseMay 2027
9027967*PEDSPIRIVA RESPIMATtiotropium bromideuseSept 2027
7713938*PEDGLYXAMBI, JARDIANCE, SYNJARDY, SYNJARDY XR, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochloride; empagliflozin; metformin hydrochlorideuseOct 2027
11033552*PEDGLYXAMBI, TRADJENTAempagliflozin; linagliptin; linagliptinuseNov 2027
8673927*PEDGLYXAMBI, JENTADUETO, JENTADUETO XR, TRADJENTAempagliflozin; linagliptin; linagliptin; linagliptin; metformin hydrochlorideuseNov 2027
9173859*PEDJENTADUETO XRlinagliptin; metformin hydrochlorideuseNov 2027
7695734MIRAPEX ERpramipexole dihydrochlorideproductApr 2028
7579449GLYXAMBI, JARDIANCE, SYNJARDY, SYNJARDY XR, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochloride; empagliflozin; metformin hydrochloridesubstanceAug 2028
7837235*PEDSPIRIVA RESPIMAT, STIOLTO RESPIMATolodaterol hydrochloride; tiotropium bromide; tiotropium bromideuseSept 2028
7579449*PEDGLYXAMBI, JARDIANCE, SYNJARDY, SYNJARDY XR, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochloride; empagliflozin; metformin hydrochlorideuseFeb 2029
8460704VIRAMUNE XRnevirapineuseMar 2029
10022379JENTADUETO, JENTADUETO XR, TRIJARDY XRempagliflozin; linagliptin; metformin hydrochloride; linagliptin; metformin hydrochlorideproductApr 2029
10973827JENTADUETOlinagliptin; metformin hydrochlorideproductApr 2029
12678442JENTADUETO, JENTADUETO XR, TRIJARDY XRempagliflozin; linagliptin; metformin hydrochloride; linagliptin; metformin hydrochlorideproductApr 2029
9415016JENTADUETO, JENTADUETO XR, TRIJARDY XRempagliflozin; linagliptin; metformin hydrochloride; linagliptin; metformin hydrochlorideproductApr 2029
10105323OFEVnintedanib esylateproductJun 2029
9907756OFEVnintedanib esylateproductJun 2029
10034877TRADJENTAlinagliptinuseAug 2029
9486526TRADJENTAlinagliptinuseAug 2029
8679533MIRAPEX ERpramipexole dihydrochlorideproductSept 2029
10022379*PEDJENTADUETO, JENTADUETO XRlinagliptin; metformin hydrochlorideuseOct 2029
10973827*PEDJENTADUETOlinagliptin; metformin hydrochlorideuseOct 2029
12678442*PEDTRIJARDY XRempagliflozin; linagliptin; metformin hydrochlorideuseOct 2029
9415016*PEDJENTADUETO, JENTADUETO XRlinagliptin; metformin hydrochlorideuseOct 2029
8426586GILOTRIFafatinib dimaleatesubstanceOct 2029
8551957GLYXAMBI, JARDIANCE, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochlorideproductOct 2029
8754073JASCAYDnerandomilastsubstance, productNov 2029
10105323*PEDOFEVnintedanib esylateuseDec 2029
9907756*PEDOFEVnintedanib esylateuseDec 2029
8545884GILOTRIFafatinib dimaleateproductDec 2029
10034877*PEDTRADJENTAlinagliptinuseFeb 2030
9486526*PEDTRADJENTAlinagliptinuseFeb 2030
12115179GLYXAMBI, JARDIANCE, SYNJARDY, SYNJARDY XR, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochloride; empagliflozin; metformin hydrochlorideuseFeb 2030
11911388JENTADUETO, JENTADUETO XR, TRADJENTAlinagliptin; linagliptin; metformin hydrochlorideuseApr 2030
8426586*PEDGILOTRIFafatinib dimaleateuseApr 2030
8551957*PEDGLYXAMBI, JARDIANCE, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochlorideuseApr 2030
9155705JENTADUETO, JENTADUETO XR, TRIJARDY XRempagliflozin; linagliptin; metformin hydrochloride; linagliptin; metformin hydrochlorideproductMay 2030
8846695JENTADUETOlinagliptin; metformin hydrochlorideuseJun 2030
10406172TRIJARDY XRempagliflozin; linagliptin; metformin hydrochlorideproductJun 2030
8545884*PEDGILOTRIFafatinib dimaleateuseJun 2030
10004743GILOTRIFafatinib dimaleateproductJul 2030
12115179*PEDGLYXAMBI, JARDIANCE, SYNJARDY, SYNJARDY XR, TRIJARDY XRempagliflozin; empagliflozin; linagliptin; empagliflozin; linagliptin; metformin hydrochloride; empagliflozin; metformin hydrochlorideuseAug 2030
10610489SYNJARDYempagliflozin; metformin hydrochlorideproductSept 2030
9155705*PEDJENTADUETO, JENTADUETO XRlinagliptin; metformin hydrochlorideuseNov 2030
8846695*PEDJENTADUETO, TRADJENTAlinagliptin; linagliptin; metformin hydrochlorideuseDec 2030
10004743*PEDGILOTRIFafatinib dimaleateuseJan 2031
9034822PRADAXAdabigatran etexilate mesylateuseJan 2031
8853156TRADJENTAlinagliptinproductMar 2031
10610489*PEDSYNJARDYempagliflozin; metformin hydrochlorideuseMar 2031
8733341*PEDSPIRIVA RESPIMATtiotropium bromideuseApr 2031
9034822*PEDPRADAXAdabigatran etexilate mesylateuseJul 2031
8853156*PEDTRADJENTAlinagliptinuseSept 2031
10596120SYNJARDY XR, TRIJARDY XRempagliflozin; linagliptin; metformin hydrochloride; empagliflozin; metformin hydrochlorideproductMar 2032
ProductExclusivityUntil
HERNEXEOSZONGERTINIBNCE New chemical entityAug 2030
JARDIANCEEMPAGLIFLOZINPED PaediatricDec 2026
JASCAYDNERANDOMILASTODE-546 Orphan drugOct 2032
JENTADUETOLINAGLIPTIN; METFORMIN HYDROCHLORIDEPED PaediatricDec 2026
JENTADUETO XRLINAGLIPTIN; METFORMIN HYDROCHLORIDEPED PaediatricDec 2026
OFEVNINTEDANIB ESYLATEPED PaediatricMar 2027
SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDEPED PaediatricDec 2026
SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDEPED PaediatricDec 2026
TRADJENTALINAGLIPTINPED PaediatricDec 2026
Catalogue

Marketed products

127
BrandGeneric nameForm / routeNDC
Adalimumab-adbmAdalimumab-adbmkit0597-0545BLA
Adalimumab-adbmAdalimumab-adbmkit0597-0555BLA
Adalimumab-adbmAdalimumab-adbmkit0597-0565BLA
Adalimumab-adbmAdalimumab-adbmkit0597-0575BLA
Adalimumab-adbmAdalimumab-adbmkit0597-0585BLA
Adalimumab-adbmAdalimumab-adbmkit0597-0595BLA
-Aldesleukinpowder12714-213DRUG FOR FURTHER PROCESSING
-Alemtuzumabsolution12714-085DRUG FOR FURTHER PROCESSING
-Alemtuzumabsolution12714-089BULK INGREDIENT
-Alemtuzumabsolution12714-210DRUG FOR FURTHER PROCESSING
-Alemtuzumabsolution12714-211BULK INGREDIENT
-Alteplasesolution12714-081BULK INGREDIENT
-Alteplasepowder12714-082DRUG FOR FURTHER PROCESSING
-Alteplasepowder12714-083DRUG FOR FURTHER PROCESSING
-Atropinepowder12714-034BULK INGREDIENT
-Atropine Sulfatepowder12714-031BULK INGREDIENT
Atrovent HFAipratropium bromideaerosol, metered, respiratory (inhalation)0597-0087NDA
-BUTYLSCOPOLAMINE BROMIDEpowder12714-011BULK INGREDIENT
Combivent Respimatipratropium bromide and albuterolspray, metered, respiratory (inhalation)0597-0024NDA
Cyltezoadalimumab-adbmkit0597-0370BLA
Cyltezoadalimumab-adbmkit0597-0375BLA
Cyltezoadalimumab-adbmkit0597-0400BLA
Cyltezoadalimumab-adbmkit0597-0405BLA
Cyltezoadalimumab-adbmkit0597-0485BLA
Cyltezoadalimumab-adbmkit0597-0495BLA
-Durvalumabsolution12714-087BULK INGREDIENT
-Empagliflozinpowder12714-201BULK INGREDIENT
Gilotrifafatinibtablet, film coated, oral0597-0137NDA
Gilotrifafatinibtablet, film coated, oral0597-0138NDA
Gilotrifafatinibtablet, film coated, oral0597-0141NDA
Glyxambiempagliflozin and linagliptintablet, film coated, oral0597-0164NDA
Glyxambiempagliflozin and linagliptintablet, film coated, oral0597-0182NDA
HERNEXEOSzongertinibtablet, film coated, oral0597-9257NDA
-Infliximabsolution12714-088BULK INGREDIENT
-Interferon beta-1bpowder12714-084DRUG FOR FURTHER PROCESSING
-Interferon-gamma1bsolution12714-080DRUG FOR FURTHER PROCESSING
JASCAYDnerandomilasttablet, film coated, oral0597-2465NDA
JASCAYDnerandomilasttablet, film coated, oral0597-7313NDA
JardianceEmpagliflozintablet, film coated, oral0597-0152NDA
JardianceEmpagliflozintablet, film coated, oral0597-0153NDA
-Jardiancepowder12714-920DRUG FOR FURTHER PROCESSING
-Jardiancepowder12714-930DRUG FOR FURTHER PROCESSING
Jentaduetolinagliptin and metformin hydrochloridetablet, film coated, oral0597-0146NDA
Jentaduetolinagliptin and metformin hydrochloridetablet, film coated, oral0597-0147NDA
Jentaduetolinagliptin and metformin hydrochloridetablet, film coated, oral0597-0148NDA
Jentadueto XRlinagliptin and metformin hydrochloridetablet, film coated, extended release, oral0597-0270NDA
Jentadueto XRlinagliptin and metformin hydrochloridetablet, film coated, extended release, oral0597-0275NDA
Micardis HCTtelmisartan and hydrochlorothiazidetablet, oral0597-0042NDA
Micardis HCTtelmisartan and hydrochlorothiazidetablet, oral0597-0043NDA
Micardis HCTtelmisartan and hydrochlorothiazidetablet, oral0597-0044NDA
-Nerandomilasttablet12714-122DRUG FOR FURTHER PROCESSING
-Nerandomilastpowder12714-350BULK INGREDIENT
Ofevnintedanibcapsule, oral0597-0143NDA
Ofevnintedanibcapsule, oral0597-0145NDA
-PHENYLEPHRINE HYDROCHLORIDEpowder12714-016BULK INGREDIENT
-Palivizumabsolution12714-231DRUG FOR FURTHER PROCESSING
-Palivizumabsolution12714-232DRUG FOR FURTHER PROCESSING
-Pembrolizumabsolution12714-090DRUG FOR FURTHER PROCESSING
-Pembrolizumabliquid12714-091DRUG FOR FURTHER PROCESSING
Pradaxadabigatran etexilate mesylatecapsule, oral0597-0108NDA
Pradaxadabigatran etexilate mesylatecapsule, oral0597-0355NDA
Pradaxadabigatran etexilate mesylatecapsule, oral0597-0360NDA
Pradaxadabigatran etexilatepellet, oral0597-0425NDA
Pradaxadabigatran etexilatepellet, oral0597-0430NDA
Pradaxadabigatran etexilatepellet, oral0597-0435NDA
Pradaxadabigatran etexilatepellet, oral0597-0440NDA
Pradaxadabigatran etexilatepellet, oral0597-0445NDA
Pradaxadabigatran etexilatepellet, oral0597-0450NDA
Praxbindidarucizumabinjection, intravenous0597-0197BLA
-Risankizumbabliquid12714-215BULK INGREDIENT
-Risankizumbabliquid12714-216BULK INGREDIENT
-Risankizumbabsolution12714-217DRUG FOR FURTHER PROCESSING
-Rituximabsolution12714-214BULK INGREDIENT
SPEVIGOspesolimab-sbzoinjection, intravenous0597-0035BLA
SPEVIGOspesolimab-sbzoinjection, intravenous0597-0620BLA
SPEVIGOspesolimab-sbzoinjection, intravenous0597-7705BLA
Spiriva HandiHalerTIOTROPIUM BROMIDEcapsule, oral, respiratory (inhalation)0597-0075NDA
Spiriva Respimattiotropium bromide inhalation sprayspray, metered, respiratory (inhalation)0597-0100NDA
Spiriva Respimattiotropium bromide inhalation sprayspray, metered, respiratory (inhalation)0597-0160NDA
Stiolto Respimattiotropium bromide and olodaterolspray, metered, respiratory (inhalation)0597-0155NDA
Striverdi Respimatolodaterol respimat inhalation sprayspray, metered, respiratory (inhalation)0597-0192NDA
Synjardyempagliflozin and metformin hydrochloridetablet, oral0597-0159NDA
Synjardyempagliflozin and metformin hydrochloridetablet, oral0597-0168NDA
Synjardyempagliflozin and metformin hydrochloridetablet, oral0597-0175NDA
Synjardyempagliflozin and metformin hydrochloridetablet, oral0597-0180NDA
-Synjardytablet12714-902DRUG FOR FURTHER PROCESSING
-Synjardytablet12714-903DRUG FOR FURTHER PROCESSING
-Synjardytablet12714-904DRUG FOR FURTHER PROCESSING
-Synjardytablet12714-906DRUG FOR FURTHER PROCESSING
Synjardy XRempagliflozin, metformin hydrochloridetablet, extended release, oral0597-0280NDA
Synjardy XRempagliflozin, metformin hydrochloridetablet, extended release, oral0597-0290NDA
Synjardy XRempagliflozin, metformin hydrochloridetablet, extended release, oral0597-0295NDA
Synjardy XRempagliflozin, metformin hydrochloridetablet, extended release, oral0597-0300NDA
-Tafasitamabpowder12714-219DRUG FOR FURTHER PROCESSING
-Telmisartangranule12714-205DRUG FOR FURTHER PROCESSING
-Tenecteplasesolution12714-233BULK INGREDIENT
-Tenecteplasepowder, for solution12714-234DRUG FOR FURTHER PROCESSING
-Tenecteplasepowder, for solution12714-236DRUG FOR FURTHER PROCESSING
-Tipranavirpowder12714-901BULK INGREDIENT
Tradjentalinagliptintablet, film coated, oral0597-0140NDA
-Tremelimumabsolution12714-104BULK INGREDIENT
Trijardy XRempagliflozin, linagliptin, metformin hydrochloridetablet, extended release, oral0597-0380NDA
Trijardy XRempagliflozin, linagliptin, metformin hydrochloridetablet, extended release, oral0597-0385NDA
Trijardy XRempagliflozin, linagliptin, metformin hydrochloridetablet, extended release, oral0597-0390NDA
Trijardy XRempagliflozin, linagliptin, metformin hydrochloridetablet, extended release, oral0597-0395NDA
-Zongertinibtablet12714-128DRUG FOR FURTHER PROCESSING
-Zongertinibpowder12714-301BULK INGREDIENT
-dabigatran etexilatepowder12714-036BULK INGREDIENT
-dabigatran etexilatepellet12714-150DRUG FOR FURTHER PROCESSING
-idarucizumabliquid12714-195BULK INGREDIENT
-idarucizumabliquid12714-196DRUG FOR FURTHER PROCESSING
-ipratropium bromidepowder12714-049BULK INGREDIENT
-linagliptinpowder12714-153BULK INGREDIENT
-linagliptin and metformin hydrochloridetablet12714-801DRUG FOR FURTHER PROCESSING
-linagliptin and metformin hydrochloridetablet12714-802DRUG FOR FURTHER PROCESSING
-nerandomilasttablet12714-123DRUG FOR FURTHER PROCESSING
-nintedanib esilatepowder12714-133BULK INGREDIENT
-olodaterolpowder12714-916BULK INGREDIENT
-palivizumabsolution12714-230BULK INGREDIENT
-spesolimabliquid12714-240BULK INGREDIENT
-tafasitamabsolution12714-212BULK INGREDIENT
-telmisartantablet12714-931DRUG FOR FURTHER PROCESSING
-telmisartantablet12714-932DRUG FOR FURTHER PROCESSING
-tiotropium bromidepowder12714-915BULK INGREDIENT
-tislelizumabliquid77657-010BULK INGREDIENT
-tislelizumabliquid77657-020DRUG FOR FURTHER PROCESSING
-trastuzumabsolution12714-235BULK INGREDIENT
Neighbours

Registered in the same town

12
Compare

Comparable companies in Germany

Enquiry

Common questions

Is Boehringer Ingelheim Biopharmaceuticals China Ltd FDA approved?
Boehringer Ingelheim Biopharmaceuticals China Ltd holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Boehringer Ingelheim Biopharmaceuticals China Ltd's drugs manufactured?
At registered sites in China, Germany. The FDA register lists Shanghai; Biberach an der Riss; Ingelheim am Rhein. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Boehringer Ingelheim Biopharmaceuticals China Ltd make?
127 products are listed under Boehringer Ingelheim Biopharmaceuticals China Ltd in the openFDA NDC Directory, most often as powder; solution; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.