Introduction to Tehran Chemie API Manufacturing Unit (TC API)
The Tehran Chemie API unit is the specialized arm of Tehran Chemie Pharmaceutical Company in the supply chain of Active Pharmaceutical Ingredients (APIs). The company operates independently under the legal identity of Tehran Chemie Active Pharmaceutical Ingredient Manufacturing Company and is currently one of the few domestic producers operating six production lines simultaneously at a fully equipped site.
1. History and Legal Structure
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Year Established: 2005, as a private company under Tehran Chemie Holding
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Location: Kaveh Industrial City, Saveh – the main hub of pharmaceutical API production in Iran; commercial and financial headquarters located in Tehran
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Knowledge-based status: Recognized in 2021 as a knowledge-based manufacturing company and benefiting from the support of the Vice-Presidency for Science and Technology
2. Infrastructure and Production Capacity
| Index | Status / Capacity |
|---|---|
| Production Lines | 6 active lines operating simultaneously (Batch & Continuous) |
| Process Areas | Multi-step chemical synthesis, crystallization, vacuum and spray dryers, jet milling |
| Pellet Facility | Dedicated unit for manufacturing controlled-release pellets for pH- and moisture-sensitive compounds |
| Clean Rooms | Class C and D in compliance with EU-GMP |
| Support Systems | Separate utility units (chiller, WFI equipment, HVAC with classified positive pressure) |
3. Product Portfolio and Therapeutic Categories
The official Tehran Chemie API website lists products in seven main clusters: cardiovascular, neurology, antihistamine, analgesic, antibiotic, antidiabetic, and gastrointestinal. The highest-volume current APIs include:
| Group | Sample API | Clinical Application |
|---|---|---|
| Cardiovascular | Rosuvastatin, Atorvastatin | Blood lipid-lowering |
| Neurology | Pregabalin, Paroxetine | Neuropathic pain / Antidepressant |
| Gastrointestinal | Pantoprazole, Metronidazole | Acid suppression / Anti-infective |
| Antibiotic | Cefixime, Clindamycin | 3rd generation cephalosporin / Lincosamide |
| Analgesic & Anti-inflammatory | Piroxicam, Naproxen | NSAID |
These items represent part of a broader list that is developed according to the holding’s requirements and domestic market demand.
4. Quality System and Certifications
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National GMP (Iran Food and Drug Administration) with periodic audits based on EU GMP requirements
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QC laboratories equipped with HPLC, GC, and FT-IR devices; step-by-step monitoring from raw material to finished product
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Independent QA department with an electronic document management system (e-DMS) for Lot traceability and CAPA
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ISO 9001 and ISO 14001 certifications for quality and environmental management (as listed in the Certificates section of the website)
5. Research & Development (R&D)
The competitive advantage of Tehran Chemie API lies in its research cores of MSc-level chemists and a multidisciplinary engineering team. This unit focuses on localization of shorter synthesis routes and development of controlled-release pellet formulations.
6. Vision
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Expanding the product portfolio to 20 strategic APIs by the end of 2027
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Launching exports to CIS, Middle East, and North Africa markets after obtaining CEP (Certificate of Suitability) for at least three products
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Investing in Continuous Manufacturing technology to improve energy efficiency and reduce process waste
Conclusion
Tehran Chemie API manufacturing unit, leveraging six modern production lines, stringent quality standards, and a dynamic R&D team, forms the primary link in the value chain of Tehran Chemie Holding. With the aim of reducing foreign currency dependence, ensuring stable API supply for Iran’s pharmaceutical plants, and securing a competitive presence in regional markets, the unit has an ambitious development plan — a growth trajectory that positions it among the frontrunners of the API industry in the country.
- Est : 1384
- Business Type : تولید کننده
- Phone : 021-26555555
- Address : تهران- ایران
- https://tehranchemieapi.com/en/