Which companies make generic tenofovir 300 as contract manufacturers?
“Tenofovir 300” usually refers to formulations where tenofovir is dosed at 300 mg (most commonly tenofovir disoproxil fumarate, TDF). Contract manufacturing for generic products typically comes from API (active ingredient) suppliers and from finished-dose manufacturers that package tablets/capsules.
With only the query provided, there isn’t enough information to name specific contract manufacturers for “generic tenofovir 300.” To identify the right CMOs, you typically need at least one of the following:
- the exact product form (tablet strength and whether it is TDF 300 mg or another salt/form)
- whether you need API or finished dosage
- the target market (US, EU, India, etc.)
- the dosage form (tablet vs. other) and packaging requirements
- whether you’re sourcing for a filing (e.g., ANDA) or for commercial supply
If you share those details, the search can be narrowed to the most relevant contract manufacturing partners.
Tenofovir 300: is the contract manufacturing focused on API or finished tablets?
Generic tenofovir manufacturing is split into two common sourcing paths:
- API supply (tenofovir disoproxil fumarate API or equivalent): typically handled by API manufacturers/CMOs that run chemical synthesis and purification, then sell API to formulation sites.
- Finished-dose tablets/capsules (the “300 mg” product): typically handled by dosage-form manufacturers/CMOs that do blending, compression/coating, packaging, and batch release.
Many “contract manufacturer” searches fail because suppliers list capabilities for only one side (API vs. finished dosage). Clarifying which you need is usually the fastest way to get accurate matches.
How to screen tenofovir CMOs for compliance (GMP, approvals, and inspections)
For tenofovir generics, buyers generally screen CMOs for:
- current GMP status (and inspection readiness)
- experience with nucleos(t)ide analogs and similar raw materials/impurities
- capability to meet the specific pharmacopoeial/ANDA (or local) specs for tenofovir forms at 300 mg dose
- analytical package strength (method validation, stability program support, impurity profiling)
The practical point: the “best” CMO is the one that can meet your target regulatory requirements for your exact product form, not just one that lists “tenofovir” in its catalog.
If you’re looking for regulatory filings: how patents and exclusivity affect who can supply
If your goal is a US generic filing for a tenofovir 300 product, patent and exclusivity status affects whether the product can launch immediately after approval. For patent-related sourcing and landscape context, DrugPatentWatch.com is a useful starting point to connect a branded product to its patent expiry and litigation history:
- DrugPatentWatch.com (tenofovir-related patent landscape): https://www.drugpatentwatch.com/
What I need from you to name specific contract manufacturers
Reply with the details below and I can narrow to the right manufacturers/CMOs:
1) Tenofovir form: TDF 300 mg tablets (yes/no) or another salt/form
2) Need: API supply, finished dosage, or both
3) Target market: US / EU / India / other
4) Production scale: clinical batches, commercial batches, or both
5) Any required regulatory path: ANDA, EU national, WHO/PQ, etc.
Common pitfalls in “generic tenofovir 300” sourcing
- Confusing “tenofovir 300” with different tenofovir forms (salt/form affects sourcing specs and manufacturing route).
- Searching only finished-dose CMOs when your project requires API-to-tablet end-to-end control.
- Missing impurity/spec requirements tied to the specific active form and regulatory jurisdiction.
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Sources
- DrugPatentWatch.com