Otsuka Pharmaceutical India is an API and finished-dose manufacturer based in Japan. 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.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| 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 |
| KAB. MALANG, Indonesia | Not on file |
| -, Indonesia | Not on file |
6 further sites are on record.
| 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
| 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 |
| CDSCO (India) | None | 4 |
| MFDS (Korea) | None | 4 |
| NCELS (KZ) | None | 3 |
| HSA (SG) | None | 2 |
| AEMPS (ES) | None | 1 |
| FDA (GH) | None | 1 |
| ANVISA (Brazil) | None | 1 |
| EMA | None | 1 |
| 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 We do not publish the identity of any buyer.
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