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原料药 API

具备 GMP / DMF 注册就绪度的原料药(API)与候选药物 · 每条标明用途、适应症与为何值得上线

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Listing Logic · Why These Products

This category is not a mere directory listing—each product is selected against the four criteria below and comes with both its 'use' and 'why it is listed' so buyers can quickly assess fit. Products are drawn from Unibest's API & Candidates supply catalog and posted after dual qualification and demand screening.

Registration-ready

We prioritize APIs already GMP/DMF-ready that can directly support regulatory filing, avoiding the compliance cost of building from scratch.

Definable Demand

We target chronic long-term therapies, (WHO) public-health procurement and specialty must-have scenarios with low, predictable demand volatility.

Mechanistic Rarity

We include first-in-class mechanisms, first approvals or molecules addressing resistance/unmet need, offering differentiated pricing power.

Supply-chain Feasibility

We also tag the number of linked intermediates—deeper in-house intermediate coverage means higher feasibility for scale-up and cost reduction.

Browse by Indication

Pick a class to see only APIs for that disease area

Browse by Patent Expiry

The cliff decides when to act — filter by window first

Expiry years are compiled from public sources and estimated on compound patents in major markets (US / EU). They exclude polymorph, process and formulation patents, term extensions and paediatric exclusivity. Values marked indicative are directional; values marked to-verify are inferred from filing era. Actual generic entry timing depends on national patent offices and the Orange Book.

4 API products · Page 1 / 1
Cardiovascular / RenalAPI (Commercialized)To be assessed6 intermediates

Finerenone

Use · Indication

Chronic kidney disease (CKD) associated with type 2 diabetes; slows renal function decline and cardiovascular events

Why Listed

The first nonsteroidal mineralocorticoid receptor antagonist (nsMRA), filling an anti-inflammatory and anti-fibrotic gap in diabetic kidney disease and recommended by major guidelines, a clearly incremental new product.

CAS
1050477-31-0
Therapeutic Area
Cardio-Renal Metabolism
Target / Mechanism
NR3C2
Labeled Purity
99%+
Nonsteroidal MRACardio-Renal ProtectionGuideline-recommended
View 6 key intermediates and enquire →
Cardiovascular / RenalAPI (Commercialized)Expiring within 2 yrs · 2027 (indicative)

Edoxaban

Use · Indication

Stroke prevention in non-valvular atrial fibrillation; treatment of DVT and pulmonary embolism

Why Listed

A next-generation oral anticoagulant (DOAC) clearly replacing warfarin, with a huge atrial-fibrillation population on chronic therapy, a clearly definable blockbuster.

CAS
480449-70-5
Therapeutic Area
Cardiovascular / Anticoagulation
Target / Mechanism
F10
Labeled Purity
98%+
Patent scope
EU major markets; US later — verify per target country
Factor Xa InhibitorDOAC AnticoagulantWarfarin Replacement
View profile & regulatory docs →
Cardiovascular / RenalAPI (Commercialized)To be assessed

Iptacopan

Use · Indication

Paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy and C3 glomerulopathy

Why Listed

The first oral complement-factor-B inhibitor, converting PNH from infusion to oral therapy and expanding into nephrology, a high-value rare-disease molecule.

CAS
1644670-37-0
Therapeutic Area
Rare Disease / Nephrology
Target / Mechanism
CFB
Labeled Purity
98%+
Complement Factor B InhibitorFirst OralRare Disease
View profile & regulatory docs →
Cardiovascular / RenalAPI (Commercialized)Off-patent · 1995

Methyldopa hydrate

Use · Indication

Treatment of hypertension, especially pregnancy-induced hypertension

Why Listed

A long-standing safe choice for pregnancy hypertension, not affecting the fetus and retained by multiple guideline sets; sustained demand as an essential medicine in emerging markets.

CAS
41372-08-1
Therapeutic Area
Cardiovascular / Pregnancy
Target / Mechanism
ADRA2A·ADRA2C·ADRA2B
Labeled Purity
99%+
Patent scope
Compound patent long expired; mature multi-source generic supply
Central AntihypertensivePregnancy-safeEssential Medicine
View profile & regulatory docs →

Supply source: Unibest API & Candidates supply catalog, sourced and delivered by Unibest. Therapeutic area, indication and selection rationale are qualitative summaries based on public drug knowledge for business reference; actual registration availability is subject to DMF/GMP documentation and the technical agreement confirmed at order.