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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

Related Intermediates →

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.

11 API products · Page 1 / 1
Anti-infectivesAPI (Commercialized)Off-patent · 2026 (indicative)4 intermediates

Letermovir

Use · Indication

Prophylaxis of cytomegalovirus (CMV) infection in adult recipients of allogeneic hematopoietic stem cell transplant

Why Listed

A first-in-class CMV terminase inhibitor replacing older ganciclovir-class agents with a better safety profile; a niche, high-value specialty API with limited competition.

CAS
917389-32-3
Therapeutic Area
Anti-infective / Transplant
Labeled Purity
98%+
Patent scope
US / EU compound patent
First-in-class CMV Terminase InhibitorTransplant Specialty
View 4 key intermediates and enquire →
Anti-infectivesAPI (Commercialized)Expiring in 3-5 yrs · 2031 (indicative)4 intermediates

Baloxavir Marboxil

Use · Indication

Single-dose oral treatment and post-exposure prophylaxis of influenza A and B

Why Listed

A novel single-oral-dose influenza agent with concentrated seasonal demand; integrated API-to-finished supply is attractive for regional pandemic stockpiling.

CAS
1985606-14-1
Therapeutic Area
Anti-infective / Antiviral
Labeled Purity
98%+
Patent scope
Compound patent in major markets
Single-dose RegimenCap-dependent Endonuclease InhibitorSeasonal Flu Demand
View 4 key intermediates and enquire →
Anti-infectivesAPI (Commercialized)To be assessed3 intermediates

Ozenoxacin

Use · Indication

Topical treatment of superficial skin bacterial infections such as impetigo

Why Listed

A topical non-fluoroquinolone quinolone targeting resistant Gram-positive bacteria; its pediatric and local-use profile offers differentiation in OTC and pediatric markets.

CAS
245765-41-7
Therapeutic Area
Anti-infective / Dermatology
Labeled Purity
98%+
Non-fluoroquinolone TopicalPediatric UseResistant Bacteria
View 3 key intermediates and enquire →
Anti-infectivesAPI (Commercialized)To be assessed

Zoliflodacin

Use · Indication

Uncomplicated gonorrhea, especially resistant Neisseria gonorrhoeae

Why Listed

An oral single-dose agent with a wholly new mechanism against antimicrobial-resistant gonorrhea, a WHO-priority AMR direction with clear public-health procurement demand.

CAS
1620458-09-4
Therapeutic Area
Anti-infective / Resistant Bacteria
Labeled Purity
98%+
Novel Topoisomerase InhibitorResistant Gonorrhea单剂口服
View profile & regulatory docs →
Anti-infectivesAPI (Commercialized)To be assessed

Vapendavir

Use · Indication

Rhinovirus infection, to reduce acute exacerbations in asthma/COPD patients

Why Listed

A capsid-binding inhibitor of rhinovirus that can reduce hospitalizations from COPD/asthma exacerbations, a scarce causal-therapy attempt in respiratory care.

CAS
439085-51-5
Therapeutic Area
Anti-infective / Respiratory
Labeled Purity
98%+
Capsid InhibitorRhinovirusRespiratory Indication
View profile & regulatory docs →
Anti-infectivesAPI (Commercialized)To be assessed

Itarnafloxin

Use · Indication

Antibacterial treatment of bacterial infectious diseases

Why Listed

A broad-spectrum fluoroquinolone with extensive clinical experience and controllable cost, suited as a mature generic supply for regional markets.

CAS
865311-47-3
Therapeutic Area
Anti-infective
Labeled Purity
98%+
Fluoroquinolone ClassOral Antibacterial
View profile & regulatory docs →
Anti-infectivesAPI (Commercialized)To be assessed

Islatravir

Use · Indication

Treatment of HIV-1 infection and long-acting pre-exposure prophylaxis (PrEP)

Why Listed

A novel nucleoside reverse-transcriptase translocation inhibitor (NRTTI) with long-acting dosing, the core evolution of HIV treatment and prevention, high strategic value.

CAS
865363-93-5
Therapeutic Area
Anti-infective / HIV
Labeled Purity
98%+
Long-acting NRTTIHIV Treatment/PreventionLow-frequency Dosing
View profile & regulatory docs →
Anti-infectivesAPI (Commercialized)Expiring within 2 yrs · 2027 (indicative)

Isavuconazole

Use · Indication

Invasive aspergillosis and mucormycosis (deep fungal infections)

Why Listed

A broad-spectrum triazole covering both aspergillus and mucor, for critical deep fungal infections in immunocompromised patients, an ICU/hematology must-have replacing amphotericin B.

CAS
241479-67-4
Therapeutic Area
Antifungal
Labeled Purity
99%+
Patent scope
US / EU compound patent
Broad-spectrum TriazoleDeep MycosisCritical Care
View profile & regulatory docs →
Anti-infectivesCandidate (In-research)To be assessed

Bemnifosbuvir Sulfate

Use · Indication

Treatment of hepatitis C virus (HCV) infection

Why Listed

An NS5B nucleotide analog with pangenotypic activity and a high resistance barrier, an important component of HCV combination and retreatment regimens.

CAS
2241337-84-6
Therapeutic Area
Antiviral / Hepatitis
Labeled Purity
98%+
NS5B Polymerase InhibitorPangenotypicCombination Regimen
View profile & regulatory docs →
Anti-infectivesCandidate (In-research)Off-patent · 2012

Abacavir hydroxyacetate

Use · Indication

Antiretroviral combination therapy for HIV-1 infection

Why Listed

A classic nucleoside reverse-transcriptase inhibitor still anchoring AIDS cocktail therapy; long-term must-have in national public-health procurement.

CAS
1446418-48-9
Therapeutic Area
Anti-infective / HIV
Labeled Purity
98%+
Patent scope
Compound patent long expired; mature multi-source generic supply
NRTIHIV Combination TherapyLong-term Therapy
View profile & regulatory docs →
Anti-infectivesAPI (Commercialized)To be assessed

Tedizolid Phosphate

Use · Indication

Acute bacterial skin and skin-structure infections (including MRSA)

Why Listed

A next-generation oxazolidinone with once-daily dosing and lower myelosuppression risk than peers, an important option against resistant Gram-positive bacteria.

CAS
856867-55-5
Therapeutic Area
Anti-infective / Resistant Bacteria
Labeled Purity
99%+
Oxazolidinone ClassOnce-dailyResistant Gram-positive Bacteria
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.