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Strictly Regulated — Licensed Manufacturers Only
Active Pharmaceutical Ingredients (APIs) are not available for retail, consumer, or general public purchase. Supply is restricted exclusively to licensed pharmaceutical manufacturers, compounding pharmacies, and registered research institutions operating under current Australian TGA regulatory frameworks and relevant state and federal legislation. All enquiries are subject to mandatory compliance verification, import permit assessment, and regulatory documentation review prior to any supply commitment. Synergy Healthcare Australia does not supply APIs outside of documented, compliant B2B procurement channels.
Active Pharmaceutical Ingredients (API)

Pharmaceutical-grade
API sourcing for
licensed manufacturers.

Synergy Healthcare Australia sources and supplies Active Pharmaceutical Ingredients to licensed pharmaceutical manufacturers and compounding pharmacies across Australia. Every API in our range is sourced from verified, GMP-certified manufacturers and supplied under strict regulatory compliance — with full documentation on every consignment.

80+
API molecules in our sourcing range
100%
GMP-certified manufacturing sources
B2B
Licensed manufacturers and institutions only
TGA
Supply aligned to Australian TGA guidelines
⛔ Not for consumer, retail or general B2B purchase
APIs are highly potent, highly regulated pharmaceutical raw materials. They are not functional food ingredients, nutritional supplements, or general industrial chemicals. Their import, storage, handling and supply in Australia is governed by the Therapeutic Goods Administration (TGA), the Therapeutic Goods Act 1989, and in some cases the Office of Drug Control (ODC) for controlled substances.

Synergy Healthcare Australia does not supply APIs to individuals, retailers, food manufacturers, or any entity that is not a licensed pharmaceutical manufacturer or registered compounding pharmacy. All supply enquiries are assessed for regulatory eligibility before any pricing, availability or lead-time information is provided.
What we do

Specialist API sourcing
for licensed pharmaceutical
manufacturers.

Synergy Healthcare Australia operates as a specialist ingredient importer and wholesale distributor within the Australian pharmaceutical supply chain. Our API range is sourced directly from WHO-GMP, US-FDA, EU-GMP and TGA-GMP certified manufacturers across Asia, Europe and North America — facilities that are qualified to produce APIs meeting international pharmacopoeial standards.

Unlike generalist chemical distributors, we focus exclusively on food, pharmaceutical and nutraceutical grade materials. That means every supplier assessment, every quality document and every shipment we handle is evaluated through the lens of a regulated pharmaceutical supply chain — not a commodity chemicals operation.

We supply APIs as direct importer and wholesale distributor — not as a manufacturer or compounding entity. We do not formulate, blend, dilute or compound APIs. All material is supplied in original manufacturer packaging with full batch documentation.

⚡ Documentation standard on every API shipment
Certificate of Analysis (CoA) · Certificate of GMP Compliance · Drug Master File (DMF) reference where applicable · Safety Data Sheet (SDS) · Country of Origin Certificate · Import permits where required by TGA or ODC · Stability data on request · Pharmacopoeial grade specification (BP/USP/Ph.Eur./IP) where applicable.
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Verified GMP-Certified Sourcing
We source APIs exclusively from manufacturers holding current GMP certification from recognised regulatory authorities — WHO, US-FDA, EU-GMP, or TGA-GMP. Every source facility is assessed before being brought into our supply network.
🚢
Regulated Import Management
API importation into Australia is a regulated activity. We manage the full import process including TGA import declarations, ODC permits for controlled substances where applicable, customs classification and biosecurity compliance for every consignment.
📄
Full Pharmacopoeial Documentation
CoA, GMP certificate, SDS and origin documentation shipped with every order. Pharmacopoeial grade specifications (BP, USP, Ph.Eur., IP) provided where applicable. DMF references available. Stability data and impurity profiles on request.
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Wholesale Distribution Only
We operate exclusively as a wholesale ingredient distributor. We do not manufacture, compound, formulate or repackage APIs. All material is supplied in original sealed manufacturer packaging with intact batch traceability from source to delivery.
Regulatory framework

API supply in Australia is governed
by strict federal regulation.

Understanding the regulatory environment is the starting point for every API supply relationship. These are not ingredients you can order the same way as food chemicals or nutraceutical raw materials.

🏛️
Therapeutic Goods Administration (TGA)
The TGA regulates the importation of APIs into Australia under the Therapeutic Goods Act 1989. Manufacturers sourcing APIs for use in registered or listed therapeutic goods must comply with TGA manufacturing principles and Good Manufacturing Practice (GMP) guidelines. Importers of APIs may be required to hold a TGA manufacturer's licence or follow TGA notification procedures depending on the product and intended use.
🔒
Office of Drug Control (ODC)
Certain APIs — including opioids, benzodiazepines, stimulants and other scheduled substances — fall under the jurisdiction of the Office of Drug Control (ODC), which operates under the Narcotic Drugs Act 1967 and the Criminal Code Act 1995. Import and export of these substances requires an ODC permit. Synergy Healthcare Australia assesses controlled substance enquiries against ODC permit requirements before any supply discussion proceeds.
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GMP — Good Manufacturing Practice
All APIs supplied by Synergy Healthcare Australia are sourced from manufacturers operating under internationally recognised GMP frameworks — WHO-GMP, US-FDA, EU-GMP or TGA-GMP. GMP compliance is not optional for APIs intended for use in therapeutic goods. Each source facility is assessed for current, valid GMP certification before being included in our sourcing network. GMP certificates are provided with every shipment.
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Pharmacopoeial Standards
APIs are assessed against relevant pharmacopoeial monographs — British Pharmacopoeia (BP), United States Pharmacopeia (USP), European Pharmacopoeia (Ph.Eur.) or Indian Pharmacopoeia (IP) depending on the molecule and customer requirement. We source materials tested and certified to the pharmacopoeial standard relevant to the intended therapeutic use and jurisdiction.
🛃
Import Controls & Border Compliance
API importation requires correct tariff classification, biosecurity compliance and — for scheduled substances — pre-import permit clearance. Synergy Healthcare Australia manages the full import compliance process for every consignment, working within Australian Border Force, TGA and ODC requirements to ensure clean, fully documented delivery to licensed recipients.
✅
End-User Verification
Before any API supply relationship commences, Synergy Healthcare Australia verifies the regulatory eligibility of the receiving entity. This includes confirming TGA manufacturing licence or equivalent registration, intended use declaration, and where applicable, ODC permit status. This is not a formality — it is a regulatory obligation that protects both parties and ensures compliant supply chains.
⛔ Important: API supply is not equivalent to food ingredient supply
APIs are not food additives, dietary supplements or nutraceutical ingredients. They are therapeutic substances with defined pharmacological action, and their supply, handling and use in Australia is subject to federal legislation that does not apply to food or nutraceutical grade materials. Attempting to procure APIs without appropriate regulatory authorisation may constitute a breach of the Therapeutic Goods Act 1989 and related Commonwealth legislation. Synergy Healthcare Australia will not facilitate non-compliant supply under any circumstances.
Our API range

Therapeutic categories
we source and supply.

Our API sourcing range spans major therapeutic categories. Availability, minimum order quantities and lead times vary by molecule — contact us for a specific product enquiry. All supply is subject to regulatory eligibility verification prior to quotation.

🦠 Anti-Infective & Antimicrobial
Antibiotics, Antifungals & Antiparasitics
APIs used in the treatment of bacterial, fungal and parasitic infections. Includes broad-spectrum antibiotics across cephalosporin and macrolide classes, antifungal agents and antiprotozoal molecules widely used in Australian compounding and manufacturing.
Cefixime Cephalexin Cefdinir Cefaclor Cefuroxime Axetil Cefpodoxime Proxetil Cefditoren Pivoxil Erythromycin (all salts) Roxithromycin Azithromycin Fluconazole Ketoconazole Miconazole Nitrate / Base Tolnaftate Silver Sulfadiazine Pyrantel Pamoate Chloroquine / Quinine / Mepacrine Primaquine / Amodiaquine Arteether / Artesunate / Artemether Iodo Chloro Hydroxy Quinoline Moxifloxacin Gemifloxacin Metronidazole Base / Benzoate Omidazole Secnidazole Tinidazole Diloxanide Furoate Povidone Iodine Chlorhexidine Base / Solution
💊 Analgesics & Anti-Inflammatory
Pain Management & Musculoskeletal APIs
NSAIDs, COX-2 inhibitors, muscle relaxants and analgesic APIs for oral, topical and parenteral formulations. Widely used in both branded pharmaceutical and compounding pharmacy applications across Australia.
Aspirin Ibuprofen (all salts) Diclofenac (all salts) Nimesulide Meloxicam Piroxicam Lomoxicam Lidocaine HCL Tramadol HCL Chlorzoxazone Thiocolchicoside Tizanidine
❤️ Cardiovascular & Metabolic
Cardiac, Hypertension & Lipid-Lowering APIs
APIs for cardiovascular disease management including antihypertensives, statins, antiplatelets and calcium channel blockers. Some of the highest-volume APIs in Australian pharmaceutical manufacturing and compounding.
Amlodipine Besylate Valsartan Losartan Atenolol Clopidogrel Rosuvastatin Atorvastatin Simvastatin Fenofibrate
🩺 Endocrine & Metabolic Disease
Diabetes & Hormonal APIs
Antidiabetic APIs across biguanide, sulfonylurea, thiazolidinedione and DPP-4 inhibitor classes. Widely used by Australian pharmaceutical manufacturers producing oral diabetes management products.
Metformin HCL Glimepiride Glibenclamide Pioglitazone HCL Saxagliptin HCL Sodium Alendronate
🧠 Central Nervous System
Neurological, Psychiatric & Anticonvulsant APIs
CNS APIs covering antidepressants, anticonvulsants, neuropathic pain agents and anxiolytics. Several molecules in this category are Schedule 4 or Schedule 8 controlled substances under Australian legislation — supply requires verified TGA and ODC compliance.
Pregabalin Gabapentin Amitriptyline HCL ES-Citalopram Oxalate Citalopram Trifluoperazine Alprazolam ⚠ Lorazepam ⚠ Topiramate Modafinil ⚠
🤧 Allergy, Respiratory & ENT
Antihistamines, Bronchodilators & Decongestants
Antihistamine and respiratory APIs for allergy, asthma and upper respiratory tract formulations. Note: Ephedrine and Pseudoephedrine are Schedule 6 / monitored precursors under Australian drug precursor legislation — strict regulatory controls apply.
Loratadine Desloratadine Levocetrizine Fexofenadine HCL Chlorpheniramine Maleate Pheniramine Maleate Dexchlorpheniramine Maleate Diphenhydramine (all salts) Triprolidine HCL Cyproheptadine HCL Guaifenesin Dextromethorphan HBr Ephedrine / Pseudoephedrine ⚠ Salbutamol / Terbutaline Montelukast Sodium Phenyl Ephedrine HCL Phenyl Propanolamine (all salts) ⚠ Ambroxol / Bromhexine
🔬 GI & Hepatic
Gastrointestinal & Proton Pump APIs
APIs for gastrointestinal conditions including proton pump inhibitors, prokinetics, antispasmodics and laxatives. High-demand molecules in both prescription and OTC pharmaceutical manufacturing across Australia.
Pantoprazole Omeprazole Rabeprazole Lansoprazole Famotidine Ranitidine Domperidone (all salts) Metoclopramide Ondansetron HCL Dihydrate Dicyclomine Hyoscine-N-Butylbromide Bisacodyl Serratiopeptidase
💆 Dermatology & Topical
Dermatological & Topical APIs
APIs for topical and transdermal applications including acne, wound care and antifungal skin treatments. Commonly used in compounding pharmacy and OTC topical product manufacturing.
Adapalene Diclofenac (topical salts) Ketoconazole Miconazole Nitrate / Base Tolnaftate Silver Sulfadiazine Povidone Iodine Lidocaine HCL Chlorhexidine Base / Solution
🔞 Sexual Health & Urology
PDE-5 Inhibitors & Urological APIs
Schedule 4 prescription-only APIs used in the treatment of erectile dysfunction and pulmonary arterial hypertension. Supply to licensed compounding pharmacies and registered manufacturers only — verified prescription-only status applies.
Sildenafil ⚠ Tadalafil ⚠ Vardenafil ⚠ Cinnarizine
⚠️ Controlled substance notation
Products marked with ⚠ are scheduled controlled substances or precursor chemicals under Australian law. These include Schedule 8 (controlled drugs) and certain Schedule 4 prescription-only medicines. Their supply requires verified ODC import permit, TGA manufacturer or sponsor registration, and documented end-use declaration. Enquiries for these molecules will not proceed without confirmation of regulatory authorisation. This is a non-negotiable condition of supply.
How API supply works

From enquiry to
compliant delivery.

API procurement is a multi-step regulated process. This is what every API supply engagement looks like from the moment you contact us to the point of delivery to your licensed facility.

01
Eligibility verification
We confirm your TGA manufacturing licence, compounding pharmacy registration, or institutional research authorisation before any supply discussion proceeds. This is mandatory for all API enquiries without exception.
02
Regulatory assessment
We assess the specific molecule against TGA requirements, import classification, and ODC scheduling status. For controlled substances, we confirm ODC permit status and import permit requirements before providing a quote.
03
Sourcing and documentation
We source the API from our verified GMP-certified manufacturing network. CoA, GMP certificate, SDS, DMF reference and origin documentation are assembled and reviewed against your pharmacopoeial specification requirements.
04
Compliant import and delivery
We manage the full import process including TGA declarations, biosecurity compliance, customs clearance and — for controlled substances — ODC permit documentation. Delivery to your licensed Australian facility with complete batch traceability.
Complete API reference list

All molecules we
source on enquiry.

The following is our current API sourcing reference list. Availability, minimum quantities, pharmacopoeial grade and lead times vary by molecule. Submit a specific product enquiry and our team will respond with availability, regulatory requirements and pricing within 4 business hours.

⛔ For licensed pharmaceutical manufacturers only
This list is published for reference by qualified pharmaceutical procurement professionals. These are not consumer products, nutritional supplements or over-the-counter substances available for general purchase. Every molecule listed below is a regulated pharmaceutical raw material. All supply is conditional on verified regulatory eligibility of the purchasing entity and the intended use.
Antibiotics — Cephalosporins
Cefixime / Cephalexin
Cefdinir / Cefaclor
Cefuroxime Axetil
Cefpodoxime Proxetil
Cefditoren Pivoxil
Antibiotics — Macrolides & Others
Erythromycin (all salts)
Roxithromycin / Azithromycin
Moxifloxacin / Gemifloxacin
Silver Sulfadiazine
Antifungals
Fluconazole
Ketoconazole
Miconazole Nitrate / Base
Tolnaftate
Povidone Iodine
Antiprotozoals & Antimalarials
Metronidazole Base / Benzoate
Omidazole / Secnidazole / Tinidazole
Diloxanide Furoate
Chloroquine / Quinine / Mepacrine
Primaquine / Amodiaquine
Arteether / Artesunate / Artemether
Iodo Chloro Hydroxy Quinoline
Pyrantel Pamoate
NSAIDs & Analgesics
Aspirin
Ibuprofen (all salts)
Diclofenac (all salts)
Nimesulide
Meloxicam / Piroxicam / Lomoxicam
Tramadol HCL ⚠
Muscle Relaxants & Local Anaesthetics
Lidocaine HCL
Chlorzoxazone
Thiocolchicoside / Colchicine
Tizanidine
Cardiovascular
Amlodipine Besylate
Valsartan / Losartan / Atenolol
Clopidogrel
Rosuvastatin / Atorvastatin / Simvastatin
Fenofibrate
Antidiabetics
Metformin HCL
Glimepiride
Glibenclamide
Pioglitazone HCL
Saxagliptin HCL
Sodium Alendronate
CNS — Anticonvulsants & Neuropathic
Pregabalin
Gabapentin
Topiramate
Trifluoperazine
Cinnarizine
CNS — Antidepressants & Anxiolytics ⚠
Amitriptyline HCL
ES-Citalopram Oxalate / Citalopram
Alprazolam ⚠ Sch. 8
Lorazepam ⚠ Sch. 8
Modafinil ⚠ Sch. 4
Antihistamines — 1st Generation
Cyproheptadine HCL
Chlorpheniramine Maleate
Pheniramine Maleate
Dexchlorpheniramine Maleate
Diphenhydramine (all salts)
Triprolidine HCL
Antihistamines — 2nd Generation
Loratadine / Desloratadine
Levocetrizine
Fexofenadine HCL
Respiratory & Bronchodilators
Salbutamol / Terbutaline
Montelukast Sodium
Guaifenesin
Dextromethorphan HBr
Ambroxol / Bromhexine
Ephedrine / Pseudoephedrine ⚠
Phenyl Ephedrine HCL
Phenyl Propanolamine (all salts) ⚠
Gastrointestinal — PPIs
Pantoprazole
Omeprazole
Rabeprazole
Lansoprazole
Famotidine / Ranitidine
Gastrointestinal — Prokinetics & Antispasmodics
Domperidone (all salts)
Metoclopramide
Ondansetron HCL Dihydrate
Dicyclomine
Hyoscine-N-Butylbromide
Bisacodyl
Serratiopeptidase
Dermatology & Topical
Adapalene
Chlorhexidine Base / Solution
Silver Sulfadiazine
Sexual Health (Schedule 4) ⚠
Sildenafil ⚠ Sch. 4
Tadalafil ⚠ Sch. 4
Vardenafil ⚠ Sch. 4
Natural Actives & Nutraceutical-Grade APIs
Curcumin / Astraxanthin
Zeaxanthin / Lutein
Colchicine (plant-derived)
⚠️ Availability disclaimer
Not all molecules listed above are maintained as standing stock. Many are sourced on a per-order basis with lead times of 4–12 weeks depending on source facility, batch availability and import clearance. Minimum order quantities, pharmacopoeial grades and pricing are provided on request following eligibility verification. This reference list is subject to change as sourcing availability and regulatory status of specific molecules evolves. Contact us for current status on any specific API.

Enquire about API supply for your licensed manufacturing operation.

All API enquiries are responded to within 4 business hours by a qualified team member. Please include your TGA licence number, the specific API, required grade and approximate quantity in your enquiry to accelerate the assessment process.

Call +61 414 057 080

Quality tested Products

Affordable Pricing

Direct From Manufacturer to Customer Warehouse