Share This Page
Suppliers and packagers for telmisartan
✉ Email this page to a colleague
telmisartan
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | TELMISARTAN | telmisartan | TABLET;ORAL | 202130 | ANDA | Alembic Pharmaceuticals Limited | 46708-608-10 | 100 TABLET in 1 CARTON (46708-608-10) | 2016-06-25 |
| Alembic | TELMISARTAN | telmisartan | TABLET;ORAL | 202130 | ANDA | Alembic Pharmaceuticals Limited | 46708-608-30 | 30 TABLET in 1 BOTTLE (46708-608-30) | 2016-06-25 |
| Alembic | TELMISARTAN | telmisartan | TABLET;ORAL | 202130 | ANDA | Alembic Pharmaceuticals Limited | 46708-608-91 | 1000 TABLET in 1 BOTTLE (46708-608-91) | 2016-06-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for telmisartan
Who Supplies Telmisartan API and Finished-Dose Products?
What companies supply telmisartan API?
Global telmisartan supply is split between (1) API manufacturers and (2) API “brand owners” that package telmisartan into branded or generic products through contract manufacturing. The API market is concentrated in Asia, with commercial scale plants in India and China and select specialized supply in other regions.
| Representative telmisartan API suppliers (manufacturers) | Supplier | Country | What they typically supply | Notes |
|---|---|---|---|---|
| Zhejiang Huahai Pharmaceutical Co., Ltd. | China | Telmisartan API | Large-scale cardiovascular API supplier; common in global generic supply chains. | |
| Aarti Pharmalabs / Aarti Industries (Aarti Group companies) | India | Telmisartan API | Cardiovascular focused API supplier; supplies multiple generic dossiers. | |
| Micro Labs / Micro Labs API footprint | India | Telmisartan API (through group manufacturing network) | Often supplies the active in finished-dose pipelines via its manufacturing ecosystem. | |
| Hetero Drugs Ltd. | India | Telmisartan API | Broad generic and cardiovascular portfolio via integrated manufacturing. | |
| Macleods Pharmaceuticals / API network | India | Telmisartan API (via contract and group supply) | Supplies telmisartan into tablets through generic channels. | |
| Dr. Reddy’s Laboratories (active pharma manufacturing) | India | Telmisartan (API and intermediates within broader portfolio) | Supplies API/intermediates for downstream operations; also participates in global generic supply. | |
| Zydus Lifesciences | India | Telmisartan-related API supply | Cardiovascular API capacity in India feeding finished-dose manufacturing. |
Practical procurement implication: telmisartan is widely stocked by multiple API suppliers because it has long been off-patent in most jurisdictions and competes largely on dossier readiness, cost, and compliance.
What companies supply telmisartan finished-dose tablets?
Finished-dose telmisartan is supplied by many generic manufacturers worldwide. Procurement and sourcing typically rely on tender-ready WHO/EMA/FDA-compliant products, depending on destination market.
| Representative telmisartan tablet suppliers (finished dose) | Company | Country | Common telmisartan strengths | Typical market role |
|---|---|---|---|---|
| Teva | Israel/US footprint | 20 mg, 40 mg, 80 mg | Major global generic supplier. | |
| Sandoz | Switzerland | 20 mg, 40 mg, 80 mg | Large generics and biosimilars group with telmisartan in portfolio. | |
| Mylan/Viatris | US/Global | 20 mg, 40 mg, 80 mg | Broad generic cardiovascular coverage. | |
| Zydus | India | 20 mg, 40 mg, 80 mg | India-origin generic supplier for export markets. | |
| Sun Pharma | India | 20 mg, 40 mg, 80 mg | Global generic cardiovascular portfolio. | |
| Dr. Reddy’s | India | 20 mg, 40 mg, 80 mg | International generics and in-country brands. | |
| Hikma | UK/Jordan | 20 mg, 40 mg, 80 mg | Strong in EU and emerging markets generics. | |
| Aurobindo | India | 20 mg, 40 mg, 80 mg | Common generic supplier for ARB tablets. |
Procurement implication: finished-dose supply depends on local registration and the specific salt form used (telmisartan is typically provided as telmisartan in tablets, with excipient systems differing by manufacturer).
How do suppliers qualify for telmisartan procurement?
What documentation and quality controls matter most?
Telmisartan procurement typically hinges on regulatory and quality readiness rather than novelty. For buyers, qualification usually includes:
- Regulatory status of the product (destination-market approved product dossiers).
- API compliance: DMF/CEP availability where applicable; CoA and batch release documentation.
- GMP compliance: inspection status of the API plant and finished-dose plant.
- Analytical package strength: impurity profile control, polymorph control where relevant, and validated HPLC/GC methods.
- Stability commitment: real-time and accelerated stability data for the marketed shelf-life.
Key buyer reality for telmisartan: the drug has mature manufacturing routes and broad supplier coverage, so differentiation comes from compliance track record, release reliability, and cost-to-supply stability.
Which supply chain structure dominates telmisartan sourcing?
Is supply typically direct API, or contract manufacturing?
For telmisartan, both models are common:
-
Direct API purchase → internal formulation/packaging
- Buyers contract finished-dose manufacturing or do it in-house.
- Requires full control of formulation change, validation, and packaging specs.
-
API purchase → outsourced finished-dose manufacturing
- Buyers sign contract manufacturing agreements for tablet manufacturing, packaging, and batch release.
- Requires tight change-control and specification alignment.
-
Finished-dose sourcing directly
- Buyers place tenders for registered finished tablets.
- Lower technical overhead, higher emphasis on regulatory documentation and market authorization.
Market signals: why telmisartan has many suppliers
Telmisartan is a mature ARB with global generic competition. Supply density is driven by:
- Long commercialization history across EU, US, and emerging markets.
- Off-patent status in most major jurisdictions for years.
- Multiple established API synthesis routes that scale economically.
- Established impurity control approaches used by numerous manufacturers.
Key Takeaways
- Telmisartan supply is highly fragmented but heavily concentrated in Asia, with multiple established API and finished-dose suppliers.
- Procurement is won on regulatory readiness, GMP history, and analytical package control, not on innovation.
- Buyers can source telmisartan through direct API-to-formulation, API plus contract manufacturing, or direct finished-dose tendering.
FAQs
Which countries are the main telmisartan API sources?
India and China dominate telmisartan API supply, with a secondary role for other regions that support specific dossier or contract manufacturing needs.
Do telmisartan suppliers offer multiple tablet strengths?
Most major generic suppliers offer telmisartan tablets commonly in 20 mg, 40 mg, and 80 mg, depending on registration in the destination market.
Is telmisartan API exchangeable across suppliers?
Not by default. While telmisartan is the same active, exchange requires qualification of the API grade, impurity profile, polymorph behavior (where applicable), and compatibility with the formulation.
What matters most for tenders: API or finished-dose?
It depends on the buyer model. Many tenders favor finished-dose compliance because it reduces technical qualification and shortens time-to-supply.
How do buyers reduce supply disruption risk?
Use dual-sourcing (two qualified API or two qualified finished-dose sources), lock quality agreements, and enforce strict specification and change-control clauses.
References
[1] European Medicines Agency (EMA), European public assessment reports and product information. (Accessed via EMA public databases). https://www.ema.europa.eu/
[2] FDA, Drugs@FDA database (for telmisartan and telmisartan-containing products). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] WHO, WHO Prequalification Programme (product listings for telmisartan when applicable). https://extranet.who.int/pqweb/
[4] USP, Compendial information for telmisartan substance and product standards where applicable. https://www.uspnf.com/
More… ↓
