Suppliers / Boehringer Ingelheim Pharma Gmbh

Boehringer Ingelheim Pharma Gmbh

Germany 2 duplicate records merged Updated 9 July 2026

Boehringer Ingelheim Pharma Gmbh is an API and finished-dose manufacturer based in Germany. It holds 6 active US drug master files and one valid CEP across a filed portfolio of 15 molecules. Its filings concentrate with MHRA (UK), AIFA (IT) and FAMHP (BE). Its GMP standing is certified by ZLG (DE), EMA and ANVISA (Brazil), among 10 authorities. Its most recent recorded inspection, by US FDA, closed on 12 November 2024 as NAI.

6
active US DMFs
1
valid CEPs
12
registered plants 2 with an FDA FEI number
3,643
filings across 42 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 12 November 2024 NAI US FDA
  • 4 June 2024 VAI US FDA
  • 30 June 2023 VAI US FDA
  • 2 March 2023 NAI US FDA
  • 4 November 2022 VAI US FDA
  • 16 September 2022 NAI US FDA
  • 22 July 2022 VAI US FDA
  • 7 October 2021 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Biberach, United Arab Emirates Not on file
Ingelheim am Rhein, United Arab Emirates Not on file
Ingelheim am Rhein, United Arab Emirates Not on file
Biberach, United Arab Emirates Not on file
D-88397 Biberach an der Riss, United Arab Emirates Not on file
Koropi, United Arab Emirates Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Afatinib Dimaleate SFDA (Saudi Arabia) 1
Albuterol US FDA 1
Atropine SFDA (Saudi Arabia) 1
Clenbuterol EDQM 1
Dabigatran Etexilate SFDA (Saudi Arabia) 1
Empagliflozin SFDA (Saudi Arabia) 1
Epinastine US FDA 1
Epinephrine SFDA (Saudi Arabia) 1
Ipratropium US FDA 1
Methocarbamol US FDA 1
Show all 15 molecules on file
Phenylephrine SFDA (Saudi Arabia) 1
Pramipexole US FDA 1
Repaglinide US FDA 1
Telmisartan SFDA (Saudi Arabia) 1
Tiotropium SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acetylsalicylic Acid finished dose Afatinib finished dose Albuterol API Ambroxol finished dose Amlodipine finished dose Ampicillin finished dose Atropine API Bisacodyl finished dose Bromhexine finished dose Budesonide finished dose Caffeine finished dose Calci finished dose
Show 63 more molecule pages
Candesartan Cilexetil finished dose Capecitabine finished dose Chlorothiazide finished dose Chlorthalidone finished dose Clarithromycin finished dose Clenbuterol API Clonidine finished dose Codeine finished dose Cromoglicic Acid finished dose Dabigatran finished dose Dabigatran Etexilate API Dabigatran Etexilate Mesilate finished dose Dextromethorphan finished dose Diazepam finished dose Dipyridamole finished dose Doxycycline finished dose Doxylamine finished dose Duloxetine finished dose Empagliflozin API Epinephrine API Flurbiprofen finished dose Ganciclovir finished dose Hydrochlorothiazide finished dose Hyoscin Butylbromid finished dose Indomethacin finished dose Ipratropium API Irbesartan finished dose Ivermectin finished dose Ketoprofen finished dose Lansoprazole finished dose Linagliptin finished dose Meloxicam finished dose Metformin finished dose Methimazole finished dose Methocarbamol API Mexiletine finished dose Morphine finished dose Mycophenolate Mofetil finished dose Nevirapine finished dose Nintedanib finished dose Nitrofurantoin finished dose Olanzapine finished dose Omeprazole finished dose Oseltamivir finished dose Oxazepam finished dose Oxymetazoline finished dose Oxytetracycline finished dose Perindopril finished dose Phenylephrine API Povidone-Iodine finished dose Pramipexole API Quetiapine finished dose Ramipril finished dose Ranitidine finished dose Repaglinide API Salbutamol API Saxagliptin finished dose Sitagliptin finished dose Tamsulosin finished dose Telmisartan API Teriparatide finished dose Tiotropium API Valganciclovir finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 383 None
AIFA (IT) 356 None
FAMHP (BE) 332 None
Health Canada 297 None
EMA 204 12
DKMA (DK) 183 None
ZLG (DE) None 16
ANVISA (Brazil) None 11
ANSM (FR) None 7
US FDA None 3
NCELS (KZ) None 2
COFEPRIS (MX) None 2
NAFDAC (NG) None 1
INVIMA (CO) None 1
AEMPS (ES) None 1

Questions about Boehringer Ingelheim Pharma Gmbh

Does Boehringer Ingelheim Pharma Gmbh hold a US DMF or a CEP?
Boehringer Ingelheim Pharma Gmbh holds 6 active US drug master files and 1 valid CEP. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Boehringer Ingelheim Pharma Gmbh FDA-registered?
2 sites operated by Boehringer Ingelheim Pharma Gmbh carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Boehringer Ingelheim Pharma Gmbh's last inspection go?
The most recent inspection on record closed on 12 November 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Boehringer Ingelheim Pharma Gmbh manufacture?
12 registered sites are on record, in United Arab Emirates, Austria, Switzerland and China (Biberach, Ingelheim Am Rhein and D-88397 Biberach An Der Riss among others). Every site is listed on this page with the register it came from.
What does Boehringer Ingelheim Pharma Gmbh make?
15 molecules are on record against Boehringer Ingelheim Pharma Gmbh, including Afatinib Dimaleate, Albuterol, Atropine and Clenbuterol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Boehringer Ingelheim Pharma Gmbh's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, ANVISA (Brazil), ANSM (FR), US FDA and 5 more. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was NAI, on 12 November 2024.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates