API Products

The Vital Importance of APIs

Pharmaceutical active ingredient (API) is the key substance for the pharmacological action of drugs, which directly determines the efficacy and safety of drugs. As the core link in the pharmaceutical industry chain, high purity and stable APIs are the basis for ensuring the consistency and bioavailability of drugs. In the context of increasingly stringent globalization regulation and the highly competitive pharmaceutical environment, a quality API supplier is a strategic choice for pharmaceutical companies to control risks, accelerate registration and enhance market competitiveness.

Our Core Advantages

Secure and stable supply chain
Complete compliance documentation (DMF available)
Manufactured under GMP environment
Cost-effective

With years of experience and technical excellence, Protheragen specializes in providing global pharmaceutical companies with a full range of high quality API products to support their innovative drug development or generic drug manufacturing.

Trusted by the Most Innovative Companies

We take pride in our API product line, as it has helped numerous companies solve their drug development or production issues.

Check out What Our Clients Say.

Jim M., Purchasing Manager

Protheragen has been a key API supplier for us for the past few years and their supply chain management has been excellent with no delays in delivery. Their product quality is consistent and meets our strict manufacturing standards. By working with Protheragen, we don’t need to worry about the supply of raw materials and can focus on pharmaceutical production.

Jim M., Purchasing Manager

David H., Senior Scientist

Last year, our company was developing a special anti-tumor drug and could not find a suitable supplier on the market. In the end, Protheragen customized the API with extremely high purity according to our needs, and their team of experts provided many valuable suggestions on the development of the formulation. This kind of in-depth cooperation capability is very rare among API suppliers.

David H., Senior Scientist

Stefan S., Quality Assurance Manager

We have purchased several APIs from Protheragen. Protheragen's product quality always meets USP standards and audit results are zero defects, so we successfully passed the FDA site inspection. Protheragen helped us shorten the drug development cycle, and its documentation integrity significantly accelerated our ANDA approval.

Stefan S., Quality Assurance Manager

Bruce D., Formulation Scientist

Due to a change in market demand for one of our drugs, we needed to change the formulation and manufacturing process. Protheragen was flexible with our demands, quickly adjusting the specifications and packaging of the API to ensure that our production runs smoothly. Their team not only provided product supply, but also provided us with market trend analysis and suggestions to help us better respond to market changes. We are very satisfied with Protheragen's service and look forward to future cooperation.

Bruce D., Formulation Scientist

Bruce D., Project Manager

Our company sources APIs across global markets, and Protheragen has become our reliable partner, maintaining stable API supplies through its optimized supply chain. They can arrange transportation flexibly according to our needs to ensure that we can receive high quality API in a timely manner. Protheragen's global supply capabilities are impressive and support our international expansion.

Bruce D., Project Manager

Comprehensive API Portfolio

Pharmaceutical ingredient production

Our API products are widely used in multiple key therapeutic fields, covering anti-tumor, nervous system diseases, hypoglycemic, hypoglycemic, metabolic and other directions, providing solid raw material support for global pharmaceutical companies.

We have built several GMP compliant production bases around the world, which are equipped with advanced production equipment and strict quality control systems to ensure that every API product meets the highest international standards. Here are some of our best-selling API products that have gained wide recognition and acclaim.

APIs for Neurological Diseases

Protheragen provides a full range of API products in line with international standards for the treatment of nervous system diseases, which are widely used in anti-depression, anti-epilepsy, neurodegenerative diseases, etc. Our nervous system API products cover mainstream nervous system targets, such as 5-HT reuptake inhibitors (SSRIs), dopamine receptor agonists, GABA analogues, NMDA receptor analogs, acetylcholinesterase inhibitors.

APIs for Neurological Diseases

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Aripiprazole	129722-12-9	Schizophrenia and bipolar I	USDMF/CEP	EP/USP Facility GMP	ABILIFY ASIMTUFII® ABILIFY MYCITE KIT® ABILIFY®
Brexpiprazole	913611-97-9	Schizophrenia, major depressive disorder and Alzheimer's disease	USDMF	In-house Facility GMP	REXULTI®
Lamotrigine	84057-84-1	Epilepsy and bipolar disorder	USDMF/CEP/Canadian DMF	EP/USP Facility GMP	LAMICTAL ODT®
Desvenlafaxine Succinate	386750-22-7	Depression	USDMF	Facility GMP	PRISTIQ®
Eslicarbazepine Acetate	236395-14-5	Adjunctive therapy for epilepsy	USDMF in processing	In-house Facility GMP	APTIOM®
Memantine Hydrochloride	41100-52-1	Severe dementia related to Alzheimer's disease	USDMF/ASMF/PMDA	USP Facility GMP	NAMZARIC®
Vutrisiran	1867157-35-4	Polyneuropathy			AMVUTTRA®
Pimavanserin Tartrate	706782-28-7	Parkinson's disease			NUPLAZID®

Anti-tumor APIs

Protheragen specializes in the rapid supply of highly effective APIs for the anti-tumor field, enabling the rapid development and commercial production of anti-tumor drugs. Our anti-tumor APIs can be used in targeted therapy, chemotherapy drugs, immunomodulators, hormone therapy, and more, and we support custom products based on customers' specific formulations.

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Enzalutamide	915087-33-1	Prostate cancer	USDMF/ASMF	In-house Facility GMP	XTANDI®
Dacomitinib	1110813-31-4	Non-small cell lung cancer	USDMF	Facility GMP	VIZIMPRO®
Olaparib	763113-22-0	Ovarian, breast and prostate cancer	USDMF/ASMF	USP Facility GMP	LYNPARZA®
Idelalisib	870281-82-6	Leukemia and cellular lymphoma	USDMF	Facility GMP	ZYDELIG®
Carfilzomib	868540-17-4	Multiple myeloma	USDMF	In-house Facility GMP	KYPROLIS®
Bendamustine Hydrochloride Monohydrate	1374784-02-7	Chronic lymphocytic leukemia and lymphoma	ASMF/Canada-HC	Facility GMP Product GMP	TREANDA®
Lenalidomide	191732-72-6	Multiple myeloma	USDMF/ASMF	In-house Facility GMP	REVLIMID®
Cabazitaxel	183133-96-2	Prostate cancer	USDMF/EMA	In-house Facility GMP	JEVTANA KIT®
Afatinib Dimaleate	850140-73-7	Non-small cell lung cancer	USDMF/ASMF	Facility GMP	GILOTRIF®
Ponatinib HCl	1114544-31-8	Chronic myeloid leukemia	USDMF/HC MF	Facility GMP	ICLUSIG®
Dasatinib	302962-49-8	Chronic myeloid leukemia		Facility GMP	SPRYCEL®
Nilotinib HCl	923288-95-3	Chronic myeloid leukemia	USDMF/CEP/EMA	EP/USP Facility GMP	TASIGNA®
Daunorubicin HCl	23541-50-6	Acute myelogenous leukemia, acute lymphoblastic leukemia and chronic myelogenous leukemia		USP Facility GMP Product GMP	VYXEOS®
Sorafenib Tosylate	475207-59-1	Liver cancer, renal cell carcinoma, and differentiated thyroid carcinoma	ASMF/CEP/USDMF	Facility GMP	NEXAVAR®
Ruxolitinib Phosphate	1092939-17-7	Intermediate or high-risk myelofibrosis	USDMF	In-house Facility GMP	JAKAFI®

Peptide APIs

Protheragen offers a full range of peptide API products for drug research and production. Peptide APIs are generally composed of dozens of short-chain amino acids and possess high activity, excellent targeting properties, and fewer side effects. We provide rapid delivery of peptide APIs with broad functions such as anti-cancer, immune regulation and hypoglycemic effects.

Peptide APIs

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Oxytocin	24346-32-5	Medical induced abortion	USDMF	GMP	OXYTOCIN®
Vasopressin	11000-17-2	Increase blood pressure	USDMF	GMP	VASOPRESSIN®
Parathyroid Hormone	12584-96-2	Hypoparathyroidism	USDMF	GMP	NATPARA®
Octreotide Acetate	760176-26-9	Long-term maintenance treatment in acromegaly	USDMF	GMP	MYCAPSSA®
Atosiban Acetate	914453-95-5	Contraction inhibitor	USDMF	GMP	TRACTOCILE®
Cetrorelix Acetate	120287-85-6	Controlling ovulation	USDMF	GMP	CETROTIDE®
Eptifibatide	188627-80-7	Anti-platelet aggregation	USDMF	GMP	EPTIFIBATIDE®
Ganirelix Acetate	123246-29-7	Reduce estrogen	USDMF	GMP	GANIRELIX ACETATE®
Thymalfasin	69440-99-9	Chronic hepatitis B	USDMF	GMP
Etelcalcetide	1262780-97-1	Chronic kidney diseases	USDMF	GMP	PARSABIV®
Somatostatin	38916-34-6	Varicose veins bleeding, gastric bleeding, etc.	USDMF	GMP	STILAMIN®
Terlipressin Acetate	14636-12-5	Improve liver and kidney functions	USDMF	GMP	TERLIVAZ®
Plecanatide	467426-54-6	Adult CIC	USDMF	GMP	TRULANCE®
Nirmatrelvir	2628280-40-8	COVID-19	USDMF	GMP	PAXLOVID (COPACKAGED)®
Ritonavir	155213-67-5	HIV	USDMF	GMP	NORVIR®
Melphalan Flufenamide	380449-54-7	Multiple myeloma	USDMF	GMP	IVRA®
Afamelanotide	75921-69-6	Darken the skin	USDMF	GMP	SCENESSE®
Carbetocin	37025-55-1	Uterine contraction	USDMF	GMP	CARBETOCIN INJECTION®
Voclosporin	515814-01-4	Lupus nephritis	USDMF	GMP	LUPKYNIS®
Ivosidenib	1448347-49-6	Acute myelogenous leukemia	USDMF	GMP	TIBSOVO®
Abaloparatide	247062-33-5	Osteoporosis in postmenopausal women	USDMF	GMP	TYMLOS®
Angiotensin II	4474-91-3	Traumatic or post-operative shock and hypotension caused by general or lumbar anesthesia	USDMF	GMP	GIAPREZA®
Terlipressin	14636-12-5	Improve liver and kidney functions	USDMF	GMP	TERLIVAZ®
Teriparatide	52232-67-4	Osteoporosis	USDMF		TERLIVAZ®
Lixisenatide	320367-13-3	Diabetes			LYXUMIA®
Grazoprevir	1350514-68-9	Hepatitis C			ZEPATIER®
Oritavancin	171099-57-3	Adult ABSSSI			KIMYRSA®
Macimorelin	381231-18-1	AGHD and CACS			MACRILEN®
Dulaglutide	923950-08-7	Type II diabetes			TRULICITY®
Albiglutide	782500-75-8	Type II diabetes			TANZEUM®
Dalbavancin	171500-79-1	Skin and soft tissue infection	USDMF		DALVANCE®
Voxilaprevir	1535212-07-7	HCV infection			VOSEVI®
Difelikefalin	1024828-77-0	Moderate to severe pruritus	USDMF		KORSUVA®

Hypoglycemic APIs

Protheragen provides pharmaceutical companies and research institutes with gram to ton quantities of hypoglycemic APIs to help customers develop safer and more effective diabetes treatments and improve the quality of life for hundreds of millions of patients worldwide. Our hypoglycemic APIs are classified by mechanism of action as insulin sensitizers and proinsulin secretagogues, including biguanides, DPP-4 inhibitors, SGLT-2 inhibitors, etc.

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Sitagliptin Phosphate	654671-78-0	Type II diabetes	ASMF/USDMF	EP/USP/IP Facility GMP	JANUMET®
Dapagliflozin	461432-26-8	Type II diabetes	USDMF	In-house Facility GMP	XIGDUO® XR
Canagliflozin	842133-18-0	Type II diabetes	USDMF	In-house Facility GMP	INVOKANA® INVOKAMET® INVOKAMET® XR
Linagliptin	668270-12-0	Type II diabetes	USDMF/ASMF/KOR	In-house Facility GMP	TRADJENTA® JENTADUETO® XR JENTADUETO®
Alogliptin Benzoate	850649-62-6	Type II diabetes	USDMF/KOR/ASMF	In-house Facility GMP	NESINA® KAZANO®
Metformin Hydrochloride	1115-70-4	Type II diabetes	ASMF/USDMF/WHO/CEP/KDMF	BP/EP/JP/USP Facility GMP Product GMP	KAZANO® XIGDUO® XR JENTADUETO® XR JENTADUETO® INVOKAMET® INVOKAMET® XR SEGLUROMET® JANUMET®
Finerenone	1050477-31-0	Type II diabetes and chronic kidney disease	USDMF	In-house Facility GMP	KERENDIA® OPSUMIT®

GLP-1 Agonist APIs

Glucagon-like peptide-1 (GLP-1) agonists bind to the GLP-1 receptor in the pancreas to promote insulin secretion and inhibit glucagon release, thereby improving glycemic controls. Protheragen provides a number of popular GLP-1 agonist APIs that enable global pharmaceutical companies to develop more effective drugs to reduce fasting and postprandial blood glucose.

GLP-1 Agonist APIs

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Semaglutide	910463-68-2	Type II diabetes	USDMF/ASMF/CEP/WC	In-house/Commerical Facility GMP	OZEMPIC®
Liraglutide	204656-20-2	Type II diabetes	USDMF	Facility GMP	SAXENDA®
Orforglipron	2212020-52-3	Type II diabetes
Retatrutide	2381089-83-2	Diabetes	USDMF	Facility GMP
Tirzepatide	2023788-19-2	Type II diabetes	USDMF	Facility GMP	MOUNJARO®

Antihypertensive APIs

As one of the most common chronic diseases, hypertension affects the quality of life and health of many patients worldwide. Protheragen's antihypertensive API products cover a wide range of categories, such as ACE inhibitors, calcium channel blockers, β-blockers, diuretics, and more. We quickly respond to the needs of pharmaceutical industry customers and provide customized API solutions.

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Selexipag	475086-01-2	Pulmonary arterial hypertension	USDMF	Facility GMP	UPTRAVI®
Macitentan	441798-33-0	Pulmonary arterial hypertension	ASMF/USDMF	In-house Facility GMP	OPSUMIT®
Amlodipine Besylate	111470-99-6	Hypertension and coronary artery disease		EP/JP Facility GMP	LOTREL®
Nimodipine	66085-59-4	Vasospasm		USP/BP/EP	NYMALIZE®
Irbesartan	138402-11-6	Hypertension		EP/USP	AVAPRO®
Telmisartan	144701-48-4	Primary hypertension			MICARDIS®

Antibacterial APIs

After a long period of development, Protheragen has established a broad antibacterial API product line to serve the R&D and manufacturing needs of global pharmaceutical companies and research institutions. Our antibacterial APIs include β-lactams, macrolides, quinolones, and special types. We are also continuously innovating to develop more efficient products to meet the challenge of antimicrobial resistance. Contact us for our latest antibacterial API list.

API product portfolio

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Tedizolid Phosphate	856867-55-5	Acute bacterial skin infections		In-house Facility GMP	SIVEXTRO® (POWDER) SIVEXTRO® (TABLET)
Cilastatin Sodium	81129-83-1	Bacterial infection		Facility GMP	PRIMAXIN®
Fidaxomicin	873857-62-6	Clostridium difficile-associated diarrhea (CDAD)	USDMF	USP/EP Facility GMP	DIFICID®
Tinidazole	19387-91-8	Protozoan infection	USDMF/CEP	Facility GMP	TINDAMAX®
Clavulanate Potassium	61177-45-5	Multiple bacterial infection	USP/EP/Facility GMP	CEP/Facility GMP	AUGMENTIN® '250'
Moxifloxacin hydrochloride	186826-86-8	Bacterial infection			AVELOX®
Linezolid	633-65-8	Broad spectrum antibacterial	USDMF	Facility GMP	ZYVOX®

Antivirus APIs

Antivirus APIs.

Protheragen provides global pharmaceutical companies with antivirus APIs that meet strict international standards. Our products are widely used in the research and production of anti-HIV, anti-influenza, anti-smallpox, anti-herpes and broad-spectrum antiviral drugs. For outbreaks of infectious diseases, we can provide timely API support for public health events.

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Tecovirimat	816458-31-8	Variola virus	USDMF/ASMF	In-house Facility GMP	TPOXX®
Lamivudine	134678-17-4	HIV-1 and HIV-2	USDMF/CEP/KDMF	Facility GMP	EPIVIR®
Tenofovir Disoproxil Fumarate	202138-50-9	Hepatitis B and HIV	USDMF/ASMF	IP Facility GMP Product GMP	ATRIPLA®
Acyclovir	59277-89-3	Varicella and shingles infections	USDMF/CEP/KDMF	USP/EP Facility GMP Product GMP	ZOVIRAX®
Sofosbuvir	1190307-88-0	Chronic hepatitis C	USDMF/WHO-APIMF/USDMF	Facility GMP	SOVALDI® (TABLET) SOVALDI® (PELLETS)
Peramivir	1041434-82-5	Acute uncomplicated influenza	KDMF/USDMF/WC	In-house Facility GMP	RAPIVAB®
Entecavir	142217-69-4	Hepatitis B			BARACLUDE®
Tenofovir Alafenamide Hemifumarate	1392275-56-7	Hepatitis B			SYMTUZA®

Other APIs

Protheragen's popular API products can also be used in the respiratory system, digestive system, analgesic/anti-inflammatory, skin, and more. It has always been our unremitting pursuit to provide excellent service and diversified choice for pharmaceutical industry customers.

Fig.1 API Stability Testing.

Product Name	CAS Number	Indication	Qualification	Standard	Related Drug Patent
Fluticasone Furoate	397864-44-7	Anaphylactic rhinitis	USDMF/ASMF/CEP	In-house Facility GMP	TRELEGY ELLIPTA®
Tiotropium Bromide	136310-93-5	Chronic obstructive pulmonary disease (COPD)	USDMF/CEP	Facility GMP	SPIRIVA RESPIMAT®
Crisaborole	906673-24-3	Atopic dermatitis	USDMF	In-house Facility GMP	EUCRISA®
Lifitegrast	1025967-78-5	Dry eye disease (DED)	USDMF	Facility GMP	XIIDRA®
Mirabegron	223673-61-8	Overactive bladder syndrome	USDMF/WC/ASMF/KDMF	USP Facility GMP	MYRBETRIQ®
Sugammadex Sodium	343306-79-6	Neuromuscular blockade induced by rocuronium and vecuronium	USDMF/ASMF	USP/EP Facility GMP	BRIDION®
Edoxaban Tosylate	480449-71-6	Stroke and blood clots	USDMF	In-house Facility GMP	SAVAYSA®
Ketorolac Tromethamine	74103-07-4	Moderate to severe pain	USDMF/CEP	USP Facility GMP Product GMP	ACULAR LS® ACUVAIL®
Dabigatran Etexilate Mesylate	872728-81-9	Stroke and blood clots	USDMF	In-house Facility GMP	PRADAXA® (PELLETS) PRADAXA® (CAPSULE)
Drospirenone	67392-87-4	Contraception	USDMF/CEP	EP/USP Facility GMP	YASMIN®
Aprepitant	170729-80-3	Nausea, vomiting	USDMF/ASMF/JDMF/CEP	USP/JP Facility GMP	EMEND® (SUSPENSION) EMEND® (CAPSULE)
Famotidine	76824-35-6	Gastrointestinal conditions related to acid secretion	USDMF	JP/Commercial Facility GMP	DUEXIS®
Ibuprofen	15687-27-1	Fever, pain and inflammation	USDMF/CEP/PMDA	BP/EP/USP/JP Facility GMP Product GMP	DUEXIS®
Celecoxib	169590-42-5	Inflammation and pain	USDMF/CEP/WC/KDMF/PMDA	EP/USP/JP Facility GMP Product GMP	CELEBREX®
Bazedoxifene Acetate	198481-33-3	Moderate to severe vasomotor symptoms in menopause and osteoporosis	Japan DMF		DUAVEE®
Sevelamer Carbonate	845273-93-0	Hyperphosphatemia related to nephropathy	USDMF/WC	In-house Facility GMP	RENVELA®
Ferric Citrate	3522-50-7	Hyperphosphatemia and iron deficiency anemia	USDMF	In-house Facility GMP	AURYXIA®
Levonorgestrel	797-63-7	Contraception	USDMF/CEP	USP/EP Facility GMP Product GMP	BALCOLTRA®
Tadalafil	171596-29-5	Erectile dysfunction			CIALIS®
Ivermectin	70288-86-7	Anti-parasitic		USP	STROMECTOL®
Meldonium	86426-17-7	Anti-ischemia		CEP	MILDRONATE
Esomeprazole Sodium	161796-78-7	Gastrointestinal disorders related to hyperacidity			NEXIUM®
Clopidogrel Bisulfate	120202-66-6	Anti-platelet aggregation			PLAVIX®
Vonoprazan Fumarate	881681-01-2	Gastrointestinal disorders related to hyperacidity			VOQUEZNA®
Rivaroxaban	366789-02-8	Anticoagulation			XARELTO®
Fasudil Hydrochloride	105628-07-7	Cardiovascular and cerebrovascular diseases			ERIL®
Ticagrelor	274693-27-5	Anti-platelet aggregation			BRILINTA®
Atorvastatin hemicalcium	134523-03-8	Reduce cholesterol			LIPITOR®
Lansoprazole	103577-45-3	Gastrointestinal disorders related to hyperacidity			PREVACID®
Tiopronin	1953-02-2	Cystinuria		Facility GMP	THIOLA®
Apixaban	503612-47-3	Venous thrombosis	USDMF/ASMF/CADMF/WC/KDMF	In-house/USP/EP/JP Facility GMP Product GMP	ELIQUIS®
Edaravone	89-25-8	Ischemic stroke			RADICAVA®
Tofacitinib Citrate	540737-29-9	Moderately to severely active Rheumatoid Arthritis	USDMF	Facility GMP	XELJANZ®
Parecoxib Sodium	198470-85-8	Analgesic			DYNASTAT®

Please note:

The above products are only a small part of our thousands of API products. If you cannot find the product you need, please contact us.
The patent information provided above is derived solely from publicly available data in the FDA Orange Book (or other cited sources) and is presented for general informational purposes only.

Get Our API Products List

We share your concern for global human health and are well aware that many clinical needs remain unmet. We are committed to continuously expanding and optimizing our API product portfolio.

How We Work

01
Demand Docking

Customers submit the products and their specification requirements, and our expert team will respond within 24 hours to provide solutions and quotations.

02
Compliant Manufacturing

We manufacture API products in GMP-compliant facilities, with complete production records and traceable test data available upon request.

03
Global Delivery

Arrive within 2-4 weeks in major global markets (can be expedited). Our global supply chain and cold chain transportation system guarantees the stable supply of our API products.

Frequently Asked Questions

01 What is the minimum order quantity (MOQ)?

Flexible MOQ available. Contact us for specific product MOQs.
02 How do you ensure the stability of your supply chain?

We have GMP production bases in several locations around the world and have qualified suppliers with long-term cooperation.
03 What is the delivery lead time? Do you support expedited orders?

Our regular order lead time is 2-4 weeks, but for expedited orders after evaluation, it can be shortened to 1 week.
04 Do you provide technical documents?

We can provide you with registration documents that meet the requirements of the major global regulatory agencies, such as DMF, process validation reports and stability study data.
05 Can you produce APIs that are under patent protection?

Strict adherence to international patent regulations is the basis of Protheragen's operations. We only supply APIs for which the patent has expired or for which you have a legitimate license. If you are unsure of the patent status of an API product, please consult us.