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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.

51 API products · Page 1 / 3
Metabolic / EndocrineCandidate (In-research)Off-patent · 2025 (indicative)

Dapagliflozin Propanediol Monohydrate

Use · Indication

Glycemic control in type 2 diabetes; reduces heart-failure hospitalization and slows chronic kidney disease progression

Why Listed

A cornerstone SGLT2 inhibitor spanning diabetes, heart failure and CKD (triple indication) with substantial global demand; GMP/DMF-ready and ideal for driving API sourcing through finished-dose registration.

CAS
960404-48-2
Therapeutic Area
Endocrine / Cardio-Renal Metabolism
Target / Mechanism
SLC5A2
Labeled Purity
99%+
Patent scope
Compound patent in major markets (EU earlier; US incl. paediatric exclusivity to 2025)
SGLT2 InhibitorMajor Chronic Disease DrugEssential Demand in Emerging Markets
View profile & regulatory docs →
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 →
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 →
Oncology / HematologyAPI (Commercialized)To be assessed3 intermediates

Apalutamide

Use · Indication

Non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer

Why Listed

A core endocrine therapy for prostate cancer requiring continuous long-term dosing, ensuring stable annual API demand and well suited to long-term FSO supply arrangements.

CAS
956104-40-8
Therapeutic Area
Oncology / Urology
Target / Mechanism
AR
Labeled Purity
98%+
Androgen Receptor InhibitorProstate CancerLong-term Therapy
View 3 key intermediates and enquire →
Oncology / HematologyAPI (Commercialized)Off-patent · 2026 (indicative)

Ruxolitinib

Use · Indication

Myelofibrosis and polycythemia vera; topical formulations for vitiligo and atopic dermatitis

Why Listed

A foundational agent in myelofibrosis with continued dermatology indication expansion; long-marketed with rigid, predictable demand, a low-volatility steady product.

CAS
941678-49-5
Therapeutic Area
Oncology / Hematology
Target / Mechanism
JAK1·JAK2
Labeled Purity
98%+
Patent scope
US compound patent incl. term extension (timing differs by market)
JAK1/2 InhibitorRare Blood DisorderMulti-indication Extension
View profile & regulatory docs →
Immunology / InflammationAPI (Commercialized)To be assessed8 intermediates

Upadacitinib

Use · Indication

Rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis and more

Why Listed

A leading oral targeted therapy in autoimmunity spanning rheumatology, dermatology and gastroenterology, with strong and definable volume upside.

CAS
1310726-60-3
Therapeutic Area
Autoimmune / Rheumatology
Target / Mechanism
JAK1·JAK2·JAK3·TYK2
Labeled Purity
98%+
Selective JAK1Oral TargetedMulti-indication
View 8 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 →
OphthalmologyAPI (Commercialized)Off-patent · 20122 intermediates

Brinzolamide

Use · Indication

Lowering intraocular pressure in open-angle glaucoma and ocular hypertension

Why Listed

Glaucoma requires lifelong therapy, sustaining steady demand for ophthalmic API; frequently combined with beta-blockers, enabling fixed-dose combination registration.

CAS
138890-62-7
Therapeutic Area
Ophthalmology
Target / Mechanism
CA2
Labeled Purity
98%+
Patent scope
Compound patent long expired; mature multi-source generic supply
Carbonic Anhydrase InhibitorEye Drop APILong-term Chronic Use
View 2 key intermediates and enquire →
Anesthesia / AnalgesiaAPI (Commercialized)Off-patent · 2005

Articaine

Use · Indication

Dental infiltration and conduction anesthesia

Why Listed

The preferred dental local anesthetic, fast-acting and highly diffusive, with consumption tied to global dental visits, a high-frequency consumable API.

CAS
23964-58-1
Therapeutic Area
Anesthesia / Dentistry
Target / Mechanism
SCN1A·SCN5A·SCN4A·SCN7A·SCN2A·+more
Labeled Purity
98%+
Patent scope
Compound patent long expired; mature multi-source generic supply
Dental Local AnestheticFast OnsetDental Staple
View profile & regulatory docs →
Anesthesia / AnalgesiaAPI (Commercialized)Off-patent · 2010

Ropivacaine

Use · Indication

Surgical anesthesia and postoperative acute pain management (epidural, nerve block)

Why Listed

A long-acting local anesthetic for enhanced-recovery (ERAS) pathways with lower cardiotoxicity than bupivacaine; growth in day-surgery directly lifts volume.

CAS
84057-95-4
Therapeutic Area
Anesthesia / Analgesia
Target / Mechanism
SCN1A·SCN5A·SCN4A·SCN7A·SCN2A·+more
Labeled Purity
98%+
Patent scope
Compound patent long expired; mature multi-source generic supply
Long-acting Amide Local AnestheticSensory-motor SeparationPostoperative Analgesia
View profile & regulatory docs →
Gastroenterology / HepatologyAPI (Commercialized)To be assessed7 intermediates

Resmetirom

Use · Indication

Non-alcoholic steatohepatitis (MASH/NASH) with hepatic fibrosis

Why Listed

The world's first approved MASH therapy, opening a vast untreated blue-ocean; numerous follow-on pipelines will scale API demand alongside the entire class.

CAS
920509-32-6
Therapeutic Area
Metabolism / Hepatology
Target / Mechanism
THRB
Labeled Purity
99%+
First Approved MASH DrugTHR-beta AgonistBlue-ocean Market
View 7 key intermediates and enquire →
Gastroenterology / HepatologyAPI (Commercialized)To be assessed

Fexuprazan

Use · Indication

Gastroesophageal reflux disease (GERD) and erosive esophagitis

Why Listed

A next-generation potassium-competitive acid blocker (P-CAB) with faster onset and no food effect versus PPIs, the upgrade direction for acid-related disease.

CAS
1902954-60-2
Therapeutic Area
Gastroenterology / Acid-related
Target / Mechanism
ATP4A·ATP4B
Labeled Purity
99%+
P-CAB Novel MechanismFast OnsetAsia-first Launch
View profile & regulatory docs →
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 →
AllergyAPI (Commercialized)Off-patent · 2022 (indicative)4 intermediates

Bilastine

Use · Indication

Relief of allergic rhinitis and chronic urticaria symptoms

Why Listed

A non-sedating second-generation antihistamine with seasonal demand and long-term use; suitable for combination with cold remedies and pediatric syrups.

CAS
202189-78-4
Therapeutic Area
Allergy
Target / Mechanism
HRH1
Labeled Purity
98%+
Patent scope
Compound patent in EU major markets
Second-generation AntihistamineNon-sedatingCommonly Reimbursed
View 4 key intermediates and enquire →
Metabolic / EndocrineAPI (Commercialized)Off-patent · 2026 (indicative)3 intermediates

Semaglutide

Use · Indication

Glycemic control in type 2 diabetes and weight management; reduces cardiovascular risk

Why Listed

The most consequential molecule in the GLP-1 class, dual-driven by diabetes and obesity with demand far exceeding capacity; a high-barrier peptide API and our top strategic product.

CAS
910463-68-2
Therapeutic Area
Endocrine / Metabolism
Target / Mechanism
GLP1R
Labeled Purity
99%+
Patent scope
China compound patent expires 2026; US / EU to 2031-2033 — wide divergence
GLP-1 Receptor AgonistBlockbusterGlycemic & Obesity Dual Indication
View 3 key intermediates and enquire →
Urology / Women's HealthAPI (Commercialized)To be assessed6 intermediates

Fezolinetant

Use · Indication

Moderate-to-severe vasomotor symptoms (hot flashes) of menopause

Why Listed

The first approved non-hormonal therapy for menopausal hot flashes, with broad scope to replace hormone therapy, a large and long-unmet patient population.

CAS
1629229-37-3
Therapeutic Area
Women's Health
Target / Mechanism
TACR3
Labeled Purity
99%+
First NK3 AntagonistNon-hormonal TherapyMenopause Segment
View 6 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed5 intermediates

Fluralaner

Use · Indication

Long-acting eradication of fleas and ticks in dogs and cats

Why Listed

A mainstream pet parasiticide with single-dose long protection; rising global pet-care spending sustains growing animal-health API demand.

CAS
864731-61-3
Therapeutic Area
Animal Health
Labeled Purity
99%+
Isoxazoline ClassLong-acting Oral/TopicalPet Parasiticide
View 5 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed4 intermediates

Afoxolaner

Use · Indication

Prevention and treatment of flea, tick and certain mite infestations in dogs and cats

Why Listed

A core oral pet parasiticide with good palatability and monthly dosing, often combined with milbemycin oxime, enabling fixed-combination product lines.

CAS
1093861-60-9
Therapeutic Area
Animal Health
Labeled Purity
98%+
Isoxazoline ClassBroad-spectrum ParasiticideOral Chewable
View 4 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed3 intermediates

Lotilaner

Use · Indication

Ectoparasite control in dogs and cats; ophthalmic use for demodex blepharitis

Why Listed

The only isoxazoline expanded into human ophthalmology (demodex blepharitis), combining a steady animal-health base with a human-use upside option.

CAS
1369852-71-0
Therapeutic Area
Animal Health / Ophthalmology
Labeled Purity
98%+
Isoxazoline ClassCross-speciesHuman Ophthalmic Expansion
View 3 key intermediates and enquire →
Animal HealthAPI (Commercialized)To be assessed2 intermediates

Sarolaner

Use · Indication

Prevention and treatment of flea, tick and other ectoparasite infestations in dogs and cats

Why Listed

One of several same-class agents, suitable as a combination supply within an animal-health portfolio to meet customers' generic and differentiated sourcing needs.

CAS
1398609-39-6
Therapeutic Area
Animal Health
Labeled Purity
98%+
Isoxazoline ClassPet Parasiticide
View 2 key intermediates and enquire →
Gastroenterology / HepatologyAPI (Commercialized)Off-patent · 2026 (indicative)

Vonoprazan

Use · Indication

Reflux esophagitis, gastric ulcer; eradication of Helicobacter pylori with antibiotics

Why Listed

The first marketed P-CAB with stronger, more durable acid suppression and markedly higher H. pylori eradication; especially sizable demand in high-H. pylori Asian markets.

CAS
881681-00-1
Therapeutic Area
Gastroenterology / H. pylori
Target / Mechanism
ATP4A·ATP4B
Labeled Purity
99%+
Patent scope
Japan compound patent; US later
First-marketed P-CABPotent Acid SuppressionH. pylori Eradication
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 →
Oncology / HematologyAPI (Commercialized)To be assessed

Itacitinib

Use · Indication

Graft-versus-host disease (GVHD) and related hematologic malignancies

Why Listed

Addresses high-unmet need in post-transplant GVHD with a clear mechanism and limited competition, well suited to registration partnerships with transplant centers.

CAS
1334298-90-6
Therapeutic Area
Hematology / Transplant
Target / Mechanism
JAK1
Labeled Purity
98%+
Selective JAK1GVHDTransplant Complication
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.