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Suppliers and packagers for OLMESARTAN MEDOXOMIL
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OLMESARTAN MEDOXOMIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 207662 | ANDA | Accord Healthcare Inc. | 16729-320-10 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-320-10) | 2018-02-16 |
| Accord Hlthcare | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 207662 | ANDA | Accord Healthcare Inc. | 16729-320-15 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-320-15) | 2018-02-16 |
| Accord Hlthcare | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 207662 | ANDA | Accord Healthcare Inc. | 16729-321-10 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-321-10) | 2017-04-27 |
| Accord Hlthcare | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 207662 | ANDA | Accord Healthcare Inc. | 16729-321-15 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-321-15) | 2017-04-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for OLMESARTAN MEDOXOMIL
Who Supplies Olmesartan Medoxomil for Pharmaceutical Manufacture?
Olmesartan medoxomil is widely sourced from multiple global chemical and pharmaceutical intermediates suppliers. Market-facing availability is supported by large-scale API and intermediate producers across China and India, plus specialty chemical houses that sell related intermediates and salts. The active pharmaceutical ingredient (API) and the medoxomil precursor supply chain is used by finished-dose manufacturers and by contract manufacturers (CMOs/CDMOs) that make olmesartan medoxomil tablets for global markets.
Which supplier segments sell olmesartan medoxomil?
Supply typically falls into four operational buckets:
-
API manufacturers (olmesartan medoxomil drug substance)
Direct production and sale of the API in standard packaging (drums, fiber drums, totes) with regulatory files (DMF/CEP) where available. -
Intermediate suppliers (medoxomil-related and aryl/heterocycle building blocks)
Firms that sell chemical intermediates used to synthesize olmesartan medoxomil, often used by API manufacturers for route optimization and capacity smoothing. -
Salt-form or crystallization-focused manufacturers
Less common because olmesartan medoxomil itself is the marketed prodrug; still relevant for solid-form control and specification compliance. -
Specialty chemical distributors and brokers
Distribute API and/or intermediates from the above producers, often packaging for smaller cGMP orders or providing logistics and documentation support.
What are the key global suppliers (API and related manufacturing sources)?
Below are major, commonly identified supply sources for olmesartan medoxomil (API) and its intermediates, based on public supplier listings, catalogs, and regulatory-supporting documentation that tends to be referenced in industry procurement and filings.
API and drug-substance suppliers commonly listed for olmesartan medoxomil
| Supplier | Primary supply role | Common geography | Procurement relevance |
|---|---|---|---|
| Hetero Drugs | API manufacturer | India | Listed in industry catalogs as an olmesartan medoxomil API source (API procurement). |
| Lupin | API manufacturer | India | One of the larger Indian API producers with broad ARB portfolios. |
| Sun Pharma (incl. Sun Pharmaceutical Industries) | API manufacturer | India | Known for API supply for global generics and branded markets. |
| Sandoz | Branded and generic medicines supply; may support API via network | Switzerland/Germany | Often relevant through finished-dose procurement channels. |
| Mylan (now Viatris) | Finished dose and procurement network | US/Europe | Typically sources via CDMO/API network rather than direct chemical sale to most buyers. |
| Apotex (Teva network) | Finished dose; may source via network | Canada | Relevant for finished-dose supply contracts and downstream API procurement through approved supply chains. |
Intermediate and specialty chemical suppliers (route components)
Intermediate availability is more fragmented than finished API, and sellers change by route and customer qualification status. Procurement due diligence usually targets the API manufacturer first, then locks intermediate sources through the approved supplier list inside the API CDMO/APIs workflow.
Examples of suppliers that commonly sell olmesartan-related chemical intermediates in chemical catalogs include large specialty-chemical firms and fine-chemical manufacturers in China and India that offer building blocks and protected intermediates for angiotensin receptor blocker (ARB) synthesis. Public catalog listings are the main proof point for these intermediates; the downstream qualification usually occurs at the API-manufacturer level.
What buyer-facing documentation and qualification usually accompanies API supply?
For cGMP API procurement of olmesartan medoxomil, suppliers typically provide the following in buyer qualification packages:
- CoA (Certificate of Analysis) per batch
- SDS (Safety Data Sheet)
- Spec sheet (assay, impurities, residual solvents, water content if applicable)
- Regulatory file support where available (DMF or CEP references)
Even where a supplier lists olmesartan medoxomil in a catalog, buyer qualification often depends on whether the supplier can support a regulatory filing and consistent impurity profiles aligned to the buyer’s reference standards.
What are the practical procurement paths to secure olmesartan medoxomil supply?
Path 1: Buy API directly for internal tableting/capsule manufacturing
- Qualify an API manufacturer
- Lock the analytical method package and impurity controls
- Build stability testing and bridging plan for the finished dose
Path 2: Use a CDMO for finished dose + API sourcing
- CDMO manages API sourcing through a qualified vendor list
- The buyer qualifies the finished-dose manufacturer’s control strategy and packaging
Path 3: Secure via distributor for time-to-supply
- Distributor sources from upstream approved producers
- Best for short-term continuity; quality and regulatory alignment still needs confirmation
How to compare suppliers for olmesartan medoxomil (decision criteria that matter)?
Qualification and regulatory readiness
- Ability to support DMF/CEP references or equivalent regulatory documentation
- Impurity profile consistency across commercial lots
- Method transfer readiness for assay and related substances
Supply continuity and capacity risk
- Multi-site manufacturing coverage
- Evidence of stable production runs over recent batches
Solid-form and process control
- Consistent crystallization/particle properties if specified by the buyer
- Control of residual solvents and degradants
Commercial terms
- MOQ, lead time, batch size, packaging format
- Contract documentation (quality agreements, change control, right to audit)
Which supplier information is most actionable for due diligence?
For olmesartan medoxomil sourcing, the most actionable items for diligence reviews tend to be:
- Regulatory file availability (DMF/CEP type support) at the API level
- Batch CoA patterns showing impurity variability within the buyer’s acceptance envelope
- Supply chain transparency (upstream intermediate source disclosure where required)
- Change control record for the past 3 to 5 years (route changes, solid form, solvent swaps)
Key Takeaways
- Olmesartan medoxomil is supplied through a multi-tier network: API manufacturers first, intermediate suppliers second, and distributors/CDMOs as downstream access points.
- Major API-producing companies are typically based in India and China, with procurement generally supported by regulatory documentation packages.
- The fastest path to operational supply is either a qualified API manufacturer or a CDMO that sources from a pre-qualified API vendor list, using batch documentation and regulatory support to complete qualification.
FAQs
1) Can I source olmesartan medoxomil API from multiple vendors at once?
Yes, and many manufacturers dual-source to manage lead time and batch continuity, but regulatory qualification requires controlled comparisons of impurity profiles and stability data after any vendor change.
2) Are intermediate suppliers interchangeable?
Intermediate sourcing is often constrained by the API manufacturer’s process control and impurity strategy. Even if an intermediate supplier offers “formally equivalent” intermediates, interchangeability depends on downstream analytical comparability and change control acceptance.
3) Which matters more: price or regulatory documentation?
Regulatory documentation and impurity control typically decide whether a supplier is usable for commercial manufacture. Price then becomes a contract and margin variable after qualification.
4) Do distributors stock olmesartan medoxomil?
Some distributors stock inventory or can access it quickly through upstream API producers. For commercial use, buyers still qualify the API manufacturer’s documentation and batch data, not just the distributor.
5) Is olmesartan medoxomil typically supplied as a solid form with strict specs?
Yes. Buyers commonly specify detailed solid-state and analytical specs (assay, related substances, residual solvents). Solid-state properties are part of the controllable quality attributes used in finished product assurance.
References (APA)
[1] Hetero Drugs. (n.d.). Olmesartan medoxomil (API) product information.
[2] Lupin. (n.d.). Generic drug substances and API portfolio: olmesartan medoxomil (API).
[3] Sun Pharmaceutical Industries. (n.d.). API portfolio and manufacturing information for olmesartan medoxomil.
[4] Viatris (formerly Mylan). (n.d.). Commercial and sourcing network information for antihypertensive products (olmesartan medoxomil-related).
[5] Teva. (n.d.). Apotex/Teva generics sourcing network information for olmesartan medoxomil-related products.
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