Suppliers / Pfizer Brasil Ltda

Pfizer Brasil Ltda

Brazil Updated 9 July 2026

Pfizer Brasil Ltda is an API and finished-dose manufacturer based in Brazil. It holds 4 valid CEPs across a filed portfolio of 3 molecules. Its filings concentrate with MEDSAFE (NZ), US FDA and ANVISA (Brazil). Its GMP standing is certified by ANVISA (Brazil), EAEU_EEC and BPOM (ID), among 15 authorities. Its most recent recorded inspection, by US FDA, closed on 13 May 2025 as VAI.

0
active US DMFs
4
valid CEPs
12
registered plants
7,277
filings across 46 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
0 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 13 May 2025 VAI US FDA
  • 7 February 2025 NAI US FDA
  • 20 January 2025 NAI US FDA
  • 17 January 2025 VAI US FDA
  • 1 November 2024 NAI US FDA
  • 25 October 2024 VAI US FDA
  • 2 May 2024 NAI US FDA
  • 1 May 2024 NAI US FDA

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

Registered plants

Site FDA FEI
Alcorcon Not on file
Mulgrave Not on file
Puurs Sint Amands Not on file
Puurs Not on file
Freiburg Not on file
PUURS Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Methylprednisolone EDQM 2
Hydrocortisone EDQM 1
Piroxicam EDQM 1

Also appears on these molecule pages

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Articaine finished dose Atorvastatin finished dose Atracurium finished dose Avibactam finished dose Axitinib finished dose Azithromycin finished dose Aztreonam finished dose Bendamustine finished dose Benzylpenicillin finished dose Bortezomib finished dose Bosutinib finished dose Bromhexine finished dose Bupivacaine finished dose Buprenorphine finished dose Busulfan finished dose Cabergoline finished dose Calcium Carbonate finished dose Calcium Folinate finished dose Carbocisteine finished dose Carboplatin finished dose Carboprost finished dose Cefepime finished dose Cefoperazone finished dose Cefotaxime finished dose Cefoxitin finished dose Ceftazidime finished dose Celecoxib finished dose Chlorpromazine finished dose Chlorthalidone finished dose Ciprofloxacin finished dose Cisatracurium finished dose Cisplatin finished dose Clindamycin finished dose Colestipol finished dose Colistin finished dose Crisaborole finished dose Crizotinib finished dose Cytarabine finished dose Dacarbazine finished dose Dantrolene finished dose Daptomycin finished dose Daunorubicin finished dose Decitabine finished dose Desogestrel finished dose Desvenlafaxine finished dose Dexmedetomidine finished dose Dexrazoxane finished dose Diazepam finished dose Diazoxide finished dose Dienogest finished dose Digoxin finished dose Diltiazem finished dose Dimenhydrinate finished dose Diphenhydramine finished dose Dobutamine finished dose Docetaxel finished dose Dofetilide finished dose Donepezil finished dose Doxazosin finished dose Doxepin finished dose Doxorubicin finished dose Doxycycline finished dose Doxylamine finished dose Drospirenone finished dose Eletriptan finished dose Ephedrine finished dose Epinephrine finished dose Epirubicin finished dose Eplerenone finished dose Erythromycin finished dose Esketamine finished dose Estradiol finished dose Eszopiclone finished dose Ethinylestradiol finished dose Etoposide finished dose Exemestane finished dose Fentanyl finished dose Ferrous finished dose Fesoterodine finished dose Fluconazole finished dose Flumazenil finished dose Fluorescein finished dose Fluorouracil finished dose Furosemide finished dose Gemcitabine finished dose Gentamicin finished dose Glibenclamide finished dose Glipizide finished dose Glyburide finished dose Guaifenesin finished dose Heparin finished dose Histidine finished dose Hydrocortisone API Hydromorphone finished dose Hydroxyzine finished dose Ifosfamide finished dose Imipenem finished dose Irinotecan finished dose Isavuconazonium finished dose Isoprenaline finished dose Ketamine finished dose Ketoprofen finished dose Labetalol finished dose Latanoprost finished dose Leucovorin finished dose Levetiracetam finished dose Levomenthol finished dose Levonorgestrel finished dose Levothyroxine finished dose Lidocaine finished dose Lincomycin finished dose Linezolid finished dose Lithium Carbonate finished dose Lorazepam finished dose Medroxyprogesterone finished dose Mefenamic Acid finished dose Meprobamate finished dose Meropenem finished dose Methenamine finished dose Methotrexate finished dose Methylprednisolone API Metronidazole finished dose Midazolam finished dose Milrinone finished dose Minocycline finished dose Minoxidil finished dose Morphine finished dose Naloxone finished dose Naltrexone finished dose Neomycin finished dose Nicotine finished dose Nifedipine finished dose Nitrofurantoin finished dose Nitroglycerin finished dose Norepinephrine finished dose Norethisterone finished dose Norgestrel finished dose Octreotide finished dose Olmesartan Medoxomil finished dose Ondansetron finished dose Oxaliplatin finished dose Oxytetracycline finished dose Paclitaxel finished dose Palbociclib finished dose Paricalcitol finished dose Pemetrexed finished dose Pemetrexed Disodium Hemipentahydrate finished dose Phenytoin finished dose Phylloquinone finished dose Piperacillin finished dose Piroxicam API Polymyxin B finished dose Povidone-Iodine finished dose Prazosin finished dose Prednisolone finished dose Primidone finished dose Promethazine finished dose Propofol finished dose Propranolol finished dose Pseudoephedrine finished dose Pyrantel finished dose Quetiapine finished dose Quinapril finished dose Regadenoson finished dose Remifentanil finished dose Rimegepant finished dose Ritonavir finished dose Rocuronium finished dose Ropivacaine finished dose Scopolamine finished dose Sertraline finished dose Sildenafil finished dose Simethicone finished dose Sirolimus finished dose Spironolactone finished dose Succinylcholine finished dose Sulbactam finished dose Sulfamethoxazole finished dose Sunitinib finished dose Tafamidis finished dose Tamoxifen finished dose Tazobactam finished dose Tetracycline finished dose Theophylline finished dose Tigecycline finished dose Tinidazole finished dose Tobramycin finished dose Tofacitinib finished dose Tolterodine finished dose Tranexamic Acid finished dose Trimebutine finished dose Vancomycin finished dose Varenicline finished dose Vasopressin finished dose Venlafaxine finished dose Verapamil finished dose Vincristine finished dose Vinorelbine finished dose Voriconazole finished dose Zavegepant finished dose Ziprasidone finished dose Zolpidem finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
MEDSAFE (NZ) 952 None
US FDA 754 10
ANVISA (Brazil) 629 30
Health Canada 629 None
INHRR (VE) 619 None
EMA 616 12
EAEU_EEC None 18
BPOM (ID) None 16
MFDS (Korea) None 6
ZLG (DE) None 4
MHRA (UK) None 4
NAFDAC (NG) None 3
HSA (SG) None 2
COFEPRIS (MX) None 2
INFARMED (PT) None 2
NCELS (KZ) None 1
TMDA (TZ) None 1
AEMPS (ES) None 1

Questions about Pfizer Brasil Ltda

Does Pfizer Brasil Ltda hold a US DMF or a CEP?
Pfizer Brasil Ltda holds 4 valid CEPs. 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.
How did Pfizer Brasil Ltda's last inspection go?
The most recent inspection on record closed on 13 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Pfizer Brasil Ltda manufacture?
12 registered sites are on record (Alcorcon, Mulgrave and Puurs Sint Amands among others). Every site is listed on this page with the register it came from.
What does Pfizer Brasil Ltda make?
3 molecules are on record against Pfizer Brasil Ltda, including Methylprednisolone, Hydrocortisone and Piroxicam. Each links through to that molecule's full manufacturer list.
Which regulators recognise Pfizer Brasil Ltda's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EEC (Eurasian Economic Union), BPOM (ID), EMA, US FDA and 10 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

  • 100 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 13 May 2025.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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