Suppliers / Otsuka Pharmaceutical India

Otsuka Pharmaceutical India

India 46 employees Updated 9 July 2026

Otsuka Pharmaceutical India is an API and finished-dose manufacturer based in India. It holds one active US drug master file across a filed portfolio of 9 molecules. Its filings concentrate with EDA (EG), BPOM (ID) and AIFA (IT). Its GMP standing is certified by BPOM (ID), US FDA and ZLG (DE), among 12 authorities. Its most recent recorded inspection, by US FDA, closed on 10 October 2025 as NAI. Customs aggregates show $20.5M of exports covering 1,991 molecules to 61 destinations in 2025.

1
active US DMFs
0
valid CEPs
12
registered plants 3 with an FDA FEI number
1,105
filings across 36 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
7 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

  • 10 October 2025 NAI US FDA
  • 11 July 2025 VAI US FDA
  • 17 June 2025 VAI US FDA
  • 16 May 2025 NAI US FDA
  • 28 June 2024 NAI US FDA
  • 22 March 2024 VAI US FDA
  • 15 September 2023 NAI US FDA
  • 6 December 2022 NAI US FDA

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

Registered plants

Site FDA FEI
Chiyoda-Ku Tokyo, Canada Not on file
Opfikon, Switzerland Not on file
Munich, Germany Not on file
Barcelona, Spain Not on file
-, Indonesia Not on file
KAB. MALANG, Indonesia Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Dextrose DAV (Vietnam) 2
Cystein DAV (Vietnam) 1
Glutamic Acid DAV (Vietnam) 1
Lysine DAV (Vietnam) 1
Natri Clorid DAV (Vietnam) 1
Natri Lactat DAV (Vietnam) 1
Potassium DAV (Vietnam) 1
Serine DAV (Vietnam) 1
Tazobactam US FDA 1

Also appears on these molecule pages

Acetaminophen finished dose Acetylcysteine finished dose Alanine finished dose Arginine finished dose Aripiprazole finished dose Aspartic Acid finished dose Brexpiprazole finished dose Busulfan finished dose Chlorhexidine finished dose Cilostazol finished dose Ciprofloxacin finished dose Decitabine finished dose
Show 24 more molecule pages
Flurbiprofen finished dose Glutamic Acid API Histidine finished dose Isoleucine finished dose Leucine finished dose Levofloxacin finished dose Lysine API Methionine finished dose Metronidazole finished dose Naloxone finished dose Natri Clorid API Ofloxacin finished dose Paracetamol finished dose Phenylalanine finished dose Proline finished dose Rabeprazole finished dose Rebamipid finished dose Serine API Succinylcholine finished dose Tazobactam API Threonine finished dose Tolvaptan finished dose Valine finished dose Voclosporin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EDA (EG) 110 2
BPOM (ID) 109 24
AIFA (IT) 104 None
FAMHP (BE) 88 None
DH (HK) 83 None
URPL (PL) 65 None
US FDA None 7
ZLG (DE) None 6
MFDS (Korea) None 4
CDSCO (India) None 4
NCELS (KZ) None 3
HSA (SG) None 2
AEMPS (ES) None 1
ANVISA (Brazil) None 1
FDA (GH) None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $3.0M 33
2025 Not reported $20.5M 61
2024 Not reported $15.8M 53
2023 Not reported $16.4M 59

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Otsuka Pharmaceutical India

Does Otsuka Pharmaceutical India hold a US DMF or a CEP?
Otsuka Pharmaceutical India holds 1 active US drug master file. 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 Otsuka Pharmaceutical India FDA-registered?
3 sites operated by Otsuka Pharmaceutical India 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 Otsuka Pharmaceutical India's last inspection go?
The most recent inspection on record closed on 10 October 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Otsuka Pharmaceutical India manufacture?
12 registered sites are on record, in Canada, Switzerland, Germany and Spain (Chiyoda-ku Tokyo, Opfikon and Munich among others). Every site is listed on this page with the register it came from.
What does Otsuka Pharmaceutical India make?
9 molecules are on record against Otsuka Pharmaceutical India, including Dextrose, Cystein, Glutamic Acid and Lysine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Otsuka Pharmaceutical India's GMP?
Current GMP certificates are on record from BPOM (ID), US FDA, ZLG (DE), MFDS (Korea), CDSCO (India) and 7 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 10 October 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
Customs aggregates
Export values, molecule and destination counts