# Small-molecule APIs: Production

How China, India and Europe split the world's API supply

Source page: https://www.materialinsights.org/chemicals/apis/production/

How China, India and Europe split the world's API supply What this tab covers Who makes it and how much: world capacity and output, utilisation, the top producing countries and companies globally and in India, concentration, new capacity coming, and each region's position.

| Measure | Figure | Detail | Source |
|---|---|---|---|
| **World capacity** | not published globally; capacity is measured in reactor volume (kL) per company |  | Laurus Labs FY26 |
| **World output** | not published globally |  |  |
| **Capacity utilisation** | not published | Indian PLI plants are ramping slowly; Chinese overcapacity pushed import prices down 40-50% for some APIs after the scheme launched (IndraStra, June 2026, citing PIB data). | IndraStra (June 2026) |
| **Concentration** | facility count understates China: by volume of KSMs and intermediates China is far larger; no public top-5 company share | Facility shares are for the US supply chain only and say nothing about tonnes. | US FDA (2019); ORF (Dec 2025) |
| **New capacity** | PLI bulk drugs: 48 projects approved, 38 commissioned by Dec 2025, about 56,800 t/yr capacity | Lyfius penicillin G 15,000 t/yr (Kakinada, 2024), Kinvan clavulanic acid 400 t/yr, Meghmani para-aminophenol 13,500 t/yr, Centrient atorvastatin 206 t/yr, Andhra Organics sulfadiazine and sartans. Three bulk drug parks (Andhra Pradesh, Gujarat, Himachal Pradesh) under development. | IndraStra citing PIB (June 2026); PSU Watch (2026); Business Today (July 2025) |

#### Top producing countries
 China 13% · 13% of API facilities supplying the US (2019); dominant in KSMs, fermentation and many commodity APIs India 18% · 18% of API facilities supplying the US (2019); third-largest medicine maker by volume European Union 26% · 26% of API facilities supplying the US (2019); Italy, Spain, Ireland, Switzerland strong in complex APIs United States 28% · 28% of API facilities supplying the US (2019); mostly innovator and controlled substances US FDA testimony (Woodcock, Oct 2019); US FDA (2019); Department of Pharmaceuticals Annual Report 2024-25; US FDA (2019)

#### Largest producers: global

| Company | Country | Volume | Year | Source |
|---|---|---|---|---|
| **Zhejiang Huahai Pharmaceutical** large sartan API supplier; 2018 valsartan NDMA recall | China | not published | 2025 | not published |
| **Teva API (TAPI)** one of the largest merchant API sellers | Israel | not published | 2025 | not published |
| **Lonza (Small Molecules)** 41.8% CORE EBITDA margin | Switzerland | 1.611 CHF billion sales | 2025 | [Lonza Full-Year Results 2025](https://links.sgx.com/1.0.0/corporate-announcements/JX40DSPFWE3XG83V/873320_20260128_Lonza%20Full-Year%20Results%202025_FINAL%20compressed.pdf) |
| **WuXi AppTec** on US DoD 1260H list from June 2026; preliminary injunction Aug 2026 | China | 45.45 RMB billion revenue (all services) | 2025 | [GEN Top 10 CDMOs 2026](https://www.genengnews.com/topics/bioprocessing/top-10-contract-development-and-manufacturing-organizations-2026/) |
| **Siegfried** | Switzerland | 1.328 CHF billion revenue | 2025 | [GEN Top 10 CDMOs 2026](https://www.genengnews.com/topics/bioprocessing/top-10-contract-development-and-manufacturing-organizations-2026/) |

#### Largest producers: India

| Company | Country | Volume | Year | Source |
|---|---|---|---|---|
| **Divi's Laboratories** EBITDA margin 32.6% | India | 106 Rs billion revenue (generics plus custom synthesis) | FY26 | [BoB Capital Markets Q4 FY26 review](https://www.barodaetrade.com/Reports/DivisLabs-Q4FY26ResultReview24May26-Research.pdf) |
| **Laurus Labs** ARV leader | India | 27.46 Rs billion API sales (generics) | FY26 | [Laurus Labs FY26 press release](https://www.lauruslabs.com/Investors/PDF/PressReleases/PressRelease-Laurus-Labs-Announces-Full-Year-FY26-Results-Revenues-at-₹6_813Cr_EBITDAat₹1_826Cr_ 26.8_ margins.pdf) |
| **Aurobindo Pharma (Lyfius, Apitoria)** largest beta-lactam integrator | India | 15,000 t/yr penicillin G capacity | 2024 | [Aurobindo press release](https://www.aurobindo.com/api/uploads/corporateannouncements/LtrToSEsLyfiusPressRelease29102024.pdf) |
| **Dr Reddy's (API business)** large merchant API and CPS unit | India | not published | FY26 | not published here |
| **Granules India** claims about 30% of global paracetamol | India | not published | 2023 | [Angel One (2023)](https://www.angelone.in/news/share-market/paracetamol-api-prices-surge-august-2023-stocks-watch) |

India makes most finished generics but imports most KSMs and fermentation intermediates. Import share of APIs by value rose from 68% in FY20 to about 72% in FY24 (estimates cited in Lok Sabha reply coverage, July 2025).

#### Position by region

| Region | Position |
|---|---|
| **US** | Generic API supply relies on India and China; BIOSECURE Act (Dec 2025) targets Chinese biotech service firms, and a Section 232 probe on pharma imports opened in 2025. |
| **EU** | Critical Medicines Act proposed 2025 to rebuild API supply; strong in complex APIs. |
| **India** | Formulation strength, KSM weakness; PLI and minimum import prices since 2026 to protect new plants. |
| **China** | Largest KSM and fermentation base; price cuts of 40-50% on some APIs after India's PLI (IndraStra 2026). |
| **Japan** | Imports many APIs; government funding domestic antibiotic API capacity (indicative). |
| **Middle East** | Minor producer; 2026 Middle East crisis raised Indian raw material costs (BoB on Divi's, May 2026). |

## Other sections

- [Summary](https://www.materialinsights.org/chemicals/apis/index.md)
- [Overview](https://www.materialinsights.org/chemicals/apis/overview/index.md)
- [Correlation](https://www.materialinsights.org/chemicals/apis/correlation/index.md)
- [Production route](https://www.materialinsights.org/chemicals/apis/routes/index.md)
- [Feedstocks](https://www.materialinsights.org/chemicals/apis/feedstocks/index.md)
- [Cycles](https://www.materialinsights.org/chemicals/apis/cycles/index.md)
- [Trading](https://www.materialinsights.org/chemicals/apis/trading/index.md)
- [Movement](https://www.materialinsights.org/chemicals/apis/movement/index.md)
- [Regulation](https://www.materialinsights.org/chemicals/apis/regulation/index.md)
- [Characteristics](https://www.materialinsights.org/chemicals/apis/characteristics/index.md)
- [Emissions](https://www.materialinsights.org/chemicals/apis/emissions/index.md)
- [Relationships](https://www.materialinsights.org/chemicals/apis/links/index.md)