Is Genentech, Inc. FDA approved?

Genentech, Inc. holds 8 FDA-registered establishments across 4 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 Genentech, Inc.'s drugs manufactured?

At registered sites in Switzerland, Germany, Singapore, the United States. The FDA register lists Basel; Kaiseraugst; Mannheim; Penzberg; Singapore; Hillsboro, OR, and 2 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Genentech, Inc. make?

93 products are listed under Genentech, Inc. in the openFDA NDC Directory, most often as injection, solution; liquid; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Genentech, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 8
Active NDC listings: 92
Live patents: 124
Exclusivities: 6
Shortage listings: 2
Countries: 4
Base: United States

Authorisation

Registered operations

Analytical testing8Active ingredient (API) manufacture7Labelling5Finished drug manufacture5Packaging5

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
F. Hoffmann-La Roche AGRegistrant: Genentech, Inc.	Grenzacherstrasse 124, Basel, CH-4058, Switzerland (CHE)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002807200482242971
F. Hoffmann-La Roche AGRegistrant: Genentech, Inc.	Wurmisweg, Kaiseraugst, CH-4303, Switzerland (CHE)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3003973536485244961
Roche Diagnostics GmbHRegistrant: Genentech, Inc.	Sandhofer Strasse 116, Mannheim, D-68305, Germany (DEU)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002806559315028860
Roche Diagnostics GmbHRegistrant: Genentech, Inc.	Nonnenwald 2, Penzberg, D-82377, Germany (DEU)	Analytical testing, Active ingredient (API) manufacture	3002806560323105205
Roche Singapore Technical Operations Pte. Ltd.Registrant: Genentech, Inc.	10 Tuas Bay Link, Singapore, 637394, Singapore (SGP)	Analytical testing, Active ingredient (API) manufacture	3007164129937189173
Genentech, Inc.	4625 NE Brookwood Pkwy, Hillsboro, Oregon (OR) 97124, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3007232634833220176
Genentech, Inc.	1 Antibody Way, Oceanside, California (CA) 92056, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3006129086146373191
Genentech, Inc.	1 DNA Way, South San Francisco, California (CA) 94080, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	2917293080129000

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Alteplase InjectionCardiovascular, Hematology, Neurology	Activase, Injection, 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE USE (NDC 50242-085-27)	To Be Discontinued	-	21 May 202621 May 2026
Oseltamivir Phosphate CapsuleAntiviral	Tamiflu, Capsule, 45 mg (NDC 0004-0801-85)	To Be Discontinued	-	30 Sept 202530 Sept 2025

Catalogue

Drug listings by form and route

92 active NDC listings: 80 human prescription drug, 12 drug for further processing. By marketing category: BLA 55, NDA 25, DRUG FOR FURTHER PROCESSING 12.

Dosage form	NDCs
injection, solution	30
liquid	9
capsule	7
injection, powder, lyophilized, for solution	7
tablet, film coated	7
injection, solution, concentrate	5
kit	5
injection	4
solution	4
concentrate	3
granule, for suspension	2
powder, for suspension	2
tablet, coated	2
granule, for solution	1
pellet	1

Route	NDCs
oral	24
intravenous	23
subcutaneous	23
intravitreal	4
respiratory (inhalation)	1

Labeller name on the listing	NDCs
genentech, inc.	92

Exclusivity

Patents and exclusivities

124

Patent	Product	Covers	Expiry
11597699	COTELLICcobimetinib fumarate	use	Oct 2026
8362002	COTELLICcobimetinib fumarate	use	Oct 2026
8362002*PED	COTELLICcobimetinib fumarate	use	Apr 2027
8673893	ROZLYTREKentrectinib	use	Jul 2028
9029356	ROZLYTREKentrectinib	substance, product	Jul 2028
9085558	ROZLYTREKentrectinib	product	Jul 2028
9255087	ROZLYTREKentrectinib	use	Jul 2028
9616059	ROZLYTREKentrectinib	use	Jul 2028
7888364	ERIVEDGEvismodegib	substance, product	Nov 2028
9278961	ERIVEDGEvismodegib	use	Dec 2028
7803839	COTELLICcobimetinib fumarate	substance, product	Nov 2029
7803839*PED	COTELLICcobimetinib fumarate	use	May 2030
9815835	XOFLUZAbaloxavir marboxil	product	Jun 2030
8242104	ITOVEBIinavolisib	substance, product	Sept 2030
8343955	ITOVEBIinavolisib	use	Sept 2030
8927710	XOFLUZAbaloxavir marboxil	product	May 2031
8299057	ROZLYTREKentrectinib	substance, product	Mar 2032
8987441	XOFLUZAbaloxavir marboxil	substance, product	Oct 2032
9586955	EVRYSDIrisdiplam	substance, product	Feb 2033
9085565	ROZLYTREKentrectinib	substance, product	May 2033
9649306	ROZLYTREKentrectinib	use	May 2033
11087354	COTELLICcobimetinib fumarate	use	Jun 2034
11087354*PED	COTELLICcobimetinib fumarate	use	Dec 2034
10231965	ROZLYTREKentrectinib	use	Feb 2035
10561651	ROZLYTREKentrectinib	use	Feb 2035
9969754	EVRYSDIrisdiplam	substance, product	May 2035
11827646	EVRYSDIrisdiplam	use	Jan 2036
10392406	XOFLUZAbaloxavir marboxil	substance	Apr 2036
10633397	XOFLUZAbaloxavir marboxil	use	Apr 2036
10478400	COTELLICcobimetinib fumarate	substance, product	Jun 2036
10590102	COTELLICcobimetinib fumarate	substance, product	Jun 2036
11254649	COTELLICcobimetinib fumarate	substance, product	Jun 2036
10851091	ITOVEBIinavolisib	substance, product	Jul 2036
11760753	ITOVEBIinavolisib	use	Jul 2036
9650393	ITOVEBIinavolisib	substance, product	Jul 2036
11938136	EVRYSDIrisdiplam	product	Nov 2036
10478400*PED	COTELLICcobimetinib fumarate	use	Dec 2036
10590102*PED	COTELLICcobimetinib fumarate	use	Dec 2036
11254649*PED	COTELLICcobimetinib fumarate	use	Dec 2036
10738037	ROZLYTREKentrectinib	substance, product	May 2037
11091469	ROZLYTREKentrectinib	use	May 2037
10759814	XOFLUZAbaloxavir marboxil	substance, product	Aug 2037
11306106	XOFLUZAbaloxavir marboxil	use	Aug 2037
11028100	ITOVEBIinavolisib	substance, product	Apr 2038
12410189	ITOVEBIinavolisib	use	Jun 2038
10398693	ROZLYTREKentrectinib	product	Jul 2038
11253515	ROZLYTREKentrectinib	product	Jul 2038
11261198	XOFLUZAbaloxavir marboxil	product	Sept 2038
12350273	EVRYSDIrisdiplam	use	Oct 2038
11534444	EVRYSDIrisdiplam	use	Oct 2038
12064438	XOFLUZAbaloxavir marboxil	product	Oct 2039
12122789	EVRYSDIrisdiplam	substance, product	Apr 2041
11925648	XOFLUZAbaloxavir marboxil	product	Apr 2041

Product	Exclusivity	Until
COTELLICCOBIMETINIB FUMARATE	ODE-416 Orphan drug	Oct 2029
EVRYSDIRISDIPLAM	M-270 Miscellaneous	Oct 2026
EVRYSDIRISDIPLAM	ODE-400 Orphan drug	May 2029
ITOVEBIINAVOLISIB	NCE New chemical entity	Oct 2029
ROZLYTREKENTRECTINIB	ODE-448 Orphan drug	Oct 2030
XOFLUZABALOXAVIR MARBOXIL	M-187 Miscellaneous	Dec 2027

Catalogue

Marketed products

Showing 92 of 93.

Brand	Generic name	Form / route	NDC
ACTEMRA	tocilizumab	injection, solution, concentrate, intravenous	50242-135BLA
ACTEMRA	tocilizumab	injection, solution, concentrate, intravenous	50242-136BLA
ACTEMRA	tocilizumab	injection, solution, concentrate, intravenous	50242-137BLA
ALECENSA	ALECTINIB HYDROCHLORIDE	capsule, oral	50242-130NDA
Actemra	tocilizumab	injection, solution, subcutaneous	50242-138BLA
Actemra ACTPen	tocilizumab	injection, solution, subcutaneous	50242-143BLA
Activase	Alteplase	kit	50242-044BLA
Activase	Alteplase	kit	50242-085BLA
-	Astegolimab	liquid	50242-400DRUG FOR FURTHER PROCESSING
Avastin	bevacizumab	injection, solution, intravenous	50242-060BLA
Avastin	bevacizumab	injection, solution, intravenous	50242-061BLA
Cathflo Activase	Alteplase	injection, powder, lyophilized, for solution, intravenous	50242-041BLA
CellCept	Mycophenolate Mofetil	capsule, oral	0004-0259NDA
CellCept	Mycophenolate Mofetil	tablet, film coated, oral	0004-0260NDA
CellCept	Mycophenolate Mofetil	powder, for suspension, oral	0004-0261NDA
CellCept	Mycophenolate Mofetil hydrochloride	injection, powder, lyophilized, for solution, intravenous	0004-0298NDA
Columvi	Glofitamab	solution, concentrate, intravenous	50242-125BLA
Columvi	Glofitamab	concentrate, intravenous	50242-127BLA
Cotellic	COBIMETINIB	tablet, film coated, oral	50242-717NDA
ERIVEDGE	vismodegib	capsule, oral	50242-140NDA
ESBRIET	PIRFENIDONE	tablet, coated, oral	50242-122NDA
ESBRIET	PIRFENIDONE	tablet, coated, oral	50242-123NDA
EVRYSDI	Risdiplam	powder, for solution, oral	50242-175NDA
EVRYSDI	Risdiplam	tablet, oral	50242-202NDA
Enspryng	Satralizumab	injection, solution, subcutaneous	50242-007BLA
Gazyva	obinutuzumab	injection, solution, concentrate, intravenous	50242-070BLA
Hemlibra	emicizumab	injection, solution, subcutaneous	50242-920BLA
Hemlibra	emicizumab	injection, solution, subcutaneous	50242-921BLA
Hemlibra	emicizumab	injection, solution, subcutaneous	50242-922BLA
Hemlibra	emicizumab	injection, solution, subcutaneous	50242-923BLA
Hemlibra	emicizumab	injection, solution, subcutaneous	50242-927BLA
Hemlibra	emicizumab	injection, solution, subcutaneous	50242-930BLA
Herceptin	Trastuzumab	injection, powder, lyophilized, for solution, intravenous	50242-132BLA
Herceptin Hylecta	Trastuzumab and hyaluronidase-oysk	injection, solution, subcutaneous	50242-077BLA
Itovebi	Inavolisib	tablet, film coated, oral	50242-079NDA
Itovebi	Inavolisib	tablet, film coated, oral	50242-084NDA
KADCYLA	ADO-TRASTUZUMAB EMTANSINE	injection, powder, lyophilized, for solution, intravenous	50242-087BLA
KADCYLA	ADO-TRASTUZUMAB EMTANSINE	injection, powder, lyophilized, for solution, intravenous	50242-088BLA
LUCENTIS	RANIBIZUMAB	injection, solution, intravitreal	50242-080BLA
LUCENTIS	RANIBIZUMAB	injection, solution, intravitreal	50242-082BLA
Lunsumio	Mosunetuzumab	concentrate, intravenous	50242-142BLA
Lunsumio	Mosunetuzumab	concentrate, intravenous	50242-159BLA
Lunsumio Velo	Mosunetuzumab	injection, subcutaneous	50242-177BLA
Lunsumio Velo	Mosunetuzumab	injection, subcutaneous	50242-201BLA
-	Mosunetuzumab	liquid	50242-242DRUG FOR FURTHER PROCESSING
-	Mosunetuzumab	liquid	50242-243DRUG FOR FURTHER PROCESSING
OCREVUS	ocrelizumab	injection, intravenous	50242-150BLA
Ocrevus Zunovo	ocrelizumab and hyaluronidase	injection, solution, subcutaneous	50242-554BLA
-	Omalizumab	liquid	50242-408DRUG FOR FURTHER PROCESSING
PERJETA	Pertuzumab	injection, solution, concentrate, intravenous	50242-145BLA
POLIVY	polatuzumab vedotin	injection, powder, lyophilized, for solution, intravenous	50242-103BLA
POLIVY	polatuzumab vedotin	injection, powder, lyophilized, for solution, intravenous	50242-105BLA
Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	injection, solution, subcutaneous	50242-245BLA
Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	injection, solution, subcutaneous	50242-260BLA
Piasky	Crovalimab	injection, solution, subcutaneous	50242-115BLA
-	Polatuzumab vedotin	liquid	50242-430DRUG FOR FURTHER PROCESSING
Pulmozyme	dornase alfa	solution, respiratory (inhalation)	50242-100BLA
-	RANIBIZUMAB	solution	50242-183DRUG FOR FURTHER PROCESSING
Rituxan	rituximab	injection, solution, intravenous	50242-051BLA
Rituxan	rituximab	injection, solution, intravenous	50242-053BLA
Rituxan Hycela	rituximab and hyaluronidase	injection, solution, subcutaneous	50242-108BLA
Rituxan Hycela	rituximab and hyaluronidase	injection, solution, subcutaneous	50242-109BLA
Rozlytrek	ENTRECTINIB	capsule, oral	50242-091NDA
Rozlytrek	ENTRECTINIB	capsule, oral	50242-094NDA
Rozlytrek	ENTRECTINIB	pellet, oral	50242-623NDA
Susvimo	Ranibizumab	injection, solution, intravitreal	50242-078BLA
TECENTRIQ	atezolizumab	injection, solution, intravenous	50242-917BLA
TECENTRIQ	atezolizumab	injection, solution, intravenous	50242-918BLA
TNKase	tenecteplase	kit	50242-014BLA
TNKase	tenecteplase	kit	50242-120BLA
TNKase	tenecteplase	kit	50242-176BLA
Tamiflu	oseltamivir phosphate	capsule, oral	0004-0800NDA
Tamiflu	oseltamivir phosphate	capsule, oral	0004-0802NDA
Tamiflu	Oseltamivir Phosphate	powder, for suspension, oral	0004-0822NDA
Tecentriq Hybreza	atezolizumab and hyaluronidase-tqjs	injection, subcutaneous	50242-933BLA
-	Tocilizumab	liquid	50242-139DRUG FOR FURTHER PROCESSING
VABYSMO	Faricimab	injection, solution, intravitreal	50242-096BLA
XOLAIR	omalizumab	injection, solution, subcutaneous	50242-040BLA
Xofluza	BALOXAVIR MARBOXIL	granule, for solution, oral	50242-583NDA
Xofluza	Baloxavir Marboxil	granule, for suspension, oral	50242-599NDA
Xofluza	Baloxavir Marboxil	granule, for suspension, oral	50242-617NDA
Xofluza	BALOXAVIR MARBOXIL	tablet, film coated, oral	50242-860NDA
Xofluza	BALOXAVIR MARBOXIL	tablet, film coated, oral	50242-877NDA
Xolair	omalizumab	injection, solution, subcutaneous	50242-227BLA
Xolair PFS	omalizumab	injection, solution, subcutaneous	50242-214BLA
Xolair PFS	omalizumab	injection, solution, subcutaneous	50242-215BLA
ZELBORAF	Vemurafenib	tablet, film coated, oral	50242-090NDA
-	bevacizumab	liquid	50242-059DRUG FOR FURTHER PROCESSING
-	dornase alfa	liquid	50242-099DRUG FOR FURTHER PROCESSING
-	pertuzumab	solution	50242-144DRUG FOR FURTHER PROCESSING
-	rituximab	liquid	50242-052DRUG FOR FURTHER PROCESSING
-	somatropin	solution	50242-931DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Merck & Co., Inc.Singapore, SGP · 5 sites
Novartis Pharmaceuticals CorporationBasel, CHE; Singapore, SGP · 2 sites
Lonza Biologics IncBasel, CHE; Singapore, SGP · 2 sites
SanofiSingapore, SGP · 2 sites
Solvias North America, LLCBasel, CHE; Kaiseraugst, CHE · 2 sites
Baxalta US Inc.Singapore, SGP
Charles River Laboratories, Inc.Singapore, SGP
AbbVie Inc.Singapore, SGP
Pfizer IncSingapore, SGP
Amgen, IncSingapore, SGP
Almac Pharma Services (Ireland) LimitedSingapore, SGP
KITE PHARMA, INC.Oceanside, CA

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Enquiry

Common questions

Is Genentech, Inc. FDA approved?: Genentech, Inc. holds 8 FDA-registered establishments across 4 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 Genentech, Inc.'s drugs manufactured?: At registered sites in Switzerland, Germany, Singapore, the United States. The FDA register lists Basel; Kaiseraugst; Mannheim; Penzberg; Singapore; Hillsboro, OR, and 2 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Genentech, Inc. make?: 93 products are listed under Genentech, Inc. in the openFDA NDC Directory, most often as injection, solution; liquid; capsule. 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.