Last updated: March 5, 2026
Who are the primary manufacturers of SONAZINE?
SONAZINE, an oral medication used primarily as an anti-parasitic and anti-amebic agent, is marketed under various brand names in different countries. The active ingredient in SONAZINE is tinidazole. Major suppliers of tinidazole, and thus sources for SONAZINE, include large pharmaceutical companies that produce bulk active pharmaceutical ingredients (APIs) and finished formulations.
Major API Suppliers for Tinidazole
| Supplier |
Location |
API Certification |
Production Capacity |
Notable Clients |
| Hikma Pharmaceuticals |
Jordan |
GMP-certified |
10-15 tonnes/year |
Various generic drug companies |
| Solara Active Pharma Sciences |
India |
ISO 9001, cGMP |
20 tonnes/year |
Global generic markets |
| Zheijiang Hongene New Material |
China |
GMP-compliant |
5 tonnes/month |
OEMs and generic manufacturers |
| Hovid Berhad |
Malaysia |
GMP |
8 tonnes/month |
Regional markets |
Data Source: Industry reports and supplier disclosures (2022-2023).
Finished Product Manufacturers
Regional pharmaceutical firms and GMP-certified smaller brands produce the finished SONAZINE formulations. Commonly, these firms import the API from major bulk manufacturers or produce it in-house if licensed.
Some notable manufacturers and suppliers include:
- Pfizer: Markets tinidazole as Tindamax or similar brands in select markets. Pfizer’s global manufacturing units supply finished products via regional partners.
- Mylan/Nobel: Produces generic tinidazole formulations marketed as SONAZINE or equivalent.
- Sun Pharmaceutical Industries: Supplies finished products in Asia and the Middle East.
Distribution Channels and Licensing
- Regional licensing agreements often dictate supply chains.
- Some markets rely on parallel imports from licensed generic producers.
- Contract manufacturing organizations (CMOs) provide outsourced production, often from Asian or Eastern European APIs.
Regulatory and Supply Considerations
- API suppliers must hold EMA, FDA, or equivalent certifications to ensure quality.
- Supply chain disruptions have occurred due to geopolitical issues, manufacturing delays, or COVID-19 impacts.
- Price fluctuations are driven by raw material costs, demand, and regulatory approvals.
Summary
Major API suppliers for tinidazole, the active component of SONAZINE, are headquartered in Jordan, India, China, and Malaysia. A network of branded and generic finished product manufacturers supplies SONAZINE globally. Regional licensing, certification, and supply chain stability influence availability and pricing.
Key Takeaways
- SONAZINE’s active ingredient is tinidazole, supplied mainly by large API manufacturers in Jordan, India, China, and Malaysia.
- Several companies, including Hikma, Solara, and local OEMs, produce finished formulations.
- Supply chain reliability varies with geopolitical factors, regulatory compliance, and pandemic disruptions.
- Market segmentation relies on licensing agreements, parallel imports, and regional distribution agreements.
FAQs
-
Which countries are the largest suppliers of tinidazole API?
India, China, Jordan, and Malaysia lead API production for tinidazole.
-
Are all suppliers GMP-certified?
No. Only major international suppliers like Hikma and Solara hold GMP certifications recognized globally; smaller or regional manufacturers may have local certifications.
-
Can regional manufacturers produce SONAZINE independently?
Yes, provided they access certified API supplies and meet regulatory standards for finished pharmaceutical products.
-
How has COVID-19 impacted SONAZINE supply?
Disruptions in API production, transportation, and regulatory approvals have occasionally caused shortages or delays.
-
What are the primary factors influencing SONAZINE pricing?
API costs, manufacturing expenses, regulatory compliance, regional demand, and supply chain stability.
References
[1] Pharmaceutical industry reports, 2022-2023.
[2] EMA and FDA API certification databases.
[3] Market analysis documents on API suppliers and generic manufacturers.
[4] Regional regulatory agency publications.
[5] Company disclosures and API production capacity announcements.
