Bulk Tadalafil API Suppliers for Pharmaceutical Manufacturing
Sourcing bulk tadalafil API is rarely a question of availability. More than a hundred companies list the molecule globally, and a large share of the US Drug Master Files on record for it come from Indian manufacturing sites.
The difficulty is verification. Most search results for tadalafil API are directories, and a directory listing does not distinguish a GMP manufacturing line from a trading company reselling material it did not make. That distinction determines whether the Certificate of Analysis in your inbox has anything to do with the drum arriving at your dock.
This guide is written for sourcing, QA and regulatory teams qualifying a tadalafil API supply for a regulated market. It covers what documentation to request, what US import genuinely requires, which specifications belong on your RFQ, and the clinical safety profile behind the molecule.
DIRECT ANSWER
Bulk tadalafil API suppliers sell the active pharmaceutical ingredient (CAS 171596-29-5) to licensed drug manufacturers, CDMOs and importers. Qualified buyers should confirm the legal manufacturing site, GMP evidence, batch-specific Certificate of Analysis, and DMF or CEP support before ordering. Tadalafil is a prescription-only PDE5 inhibitor and is not sold to consumers.
Search “tadalafil API supplier” and you will get a wall of directories, each promising verified, GMP-certified, export-ready material. What almost none of them give you is a way to tell a real manufacturing site from a trading company with a good letterhead. That gap is where procurement risk lives.
This guide is written for sourcing, QA and regulatory teams at pharmaceutical manufacturers, CDMOs, importers and distributors evaluating bulk tadalafil for a regulated market. It covers what documentation to demand, what US import actually requires, which specifications belong on your RFQ, and the clinical safety facts your regulatory reviewers will be asked about.
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171596-29-5 CAS NUMBER |
PDE5 Inhibitor DRUG CLASS |
USP / EP / BP COMMON GRADES |
25 kg drum TYPICAL PACK |
Major Tadalafil API Manufacturers
India remains the primary source of Tadalafil active pharmaceutical ingredient for regulated and semi-regulated markets. The producers below are among the most frequently cited, and each differs in facility accreditation, available pharmacopoeial grades, and export documentation support.
Chemox Pharma
Operates a WHO-GMP-compliant facility in Gujarat, offering Tadalafil Citrate (CAS 171596-29-5) in IP, BP, EP, and USP grades.
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CAS NUMBER
171596-29-5
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GRADES
IP / BP / EP / USP
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PACKAGING
25 kg HDPE drums
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FACILITY
WHO-GMP, Gujarat
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Century Pharmaceuticals
VADODARA, GUJARAT
Known for high-purity Tadalafil API production with strict HPLC assay and impurity control.
Sun Pharmaceutical Industries
GLOBAL SCALE PRODUCER
A global giant providing high-grade Tadalafil APIs that comply with international regulatory standards.
Dr. Reddy’s Laboratories
REGULATED MARKETS (US, EU)
Specializes in complex API synthesis and strict quality control for regulated markets such as the United States and Europe.
Atom Pharma
EXPORT DOCUMENTATION AND LOGISTICS
A recognized exporter providing comprehensive documentation, Certificate of Analysis (CoA) and logistics support for global trade.
BEFORE SOURCING
Tadalafil is a prescription-only molecule in most jurisdictions, and its API is supplied business-to-business only. Confirm current GMP certification status, the applicable pharmacopoeial grade, a batch-specific Certificate of Analysis, and the import requirements of the destination market before placing an order.
What is tadalafil API, and what is it used to manufacture?
Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor supplied as a non-sterile bulk drug substance. Formulators convert it into oral solid dosage forms, most commonly film-coated tablets. It is the same molecule marketed under the brand names Cialis and Adcirca. [Source: FDA prescribing information, CIALIS (tadalafil) tablets]
Approved indications the API supports
In the United States, tadalafil products carry FDA-approved labelling for the following on-label uses. [Source: FDA prescribing information, CIALIS; FDA prescribing information, ADCIRCA]
- Erectile dysfunction (ED)
- Signs and symptoms of benign prostatic hyperplasia (BPH)
- ED and BPH occurring together
- Pulmonary arterial hypertension (PAH), WHO Group 1, to improve exercise ability
Any other proposed use is off-label. Off-label indications are outside the scope of the approved labelling and would require the buyer’s own regulatory justification in the destination market. A bulk API purchase does not confer any right to market a product for an unapproved use.
Commercial strengths and dosage forms
| Reference product | Indication | Strengths | Regimen on label |
|---|---|---|---|
| Cialis (tadalafil) | ED, as needed | 5, 10, 20 mg | Prior to anticipated activity |
| Cialis (tadalafil) | ED, once daily | 2.5, 5 mg | Once daily, continuous plasma levels |
| Cialis (tadalafil) | BPH, or ED plus BPH | 5 mg | Once daily |
| Adcirca (tadalafil) | PAH | 20 mg tablet | 40 mg once daily (two 20 mg tablets) |
Table is informational and reflects US approved labelling. It is not dosing guidance for any individual. [Source: FDA prescribing information, CIALIS and ADCIRCA]
Tadalafil has a terminal half-life of roughly 17.5 hours, and clinical studies have shown effects at time points up to 36 hours after a dose. That pharmacokinetic profile is what differentiates the once-daily regimen from as-needed use, and it also drives the 48-hour nitrate washout guidance discussed later. [Source: FDA prescribing information, CIALIS, Clinical Pharmacology section]
Manufacturer, exporter, or trader: who are you actually buying from?
This is the single most useful distinction in API sourcing, and most supplier directories blur it. Three different roles routinely present themselves with the same word, “supplier.”
| Role | What they control | Can hold a DMF? |
|---|---|---|
| API manufacturer | Synthesis, the GMP production line, the site, batch records, stability program | Yes |
| Merchant exporter | Invoice, packing list, certificate of origin, shipping route, exporter of record | No |
| Trader or broker | A commercial relationship only, often with the true site undisclosed | No |
Working with an exporter is entirely legitimate, and for many buyers it is the practical route. The problem is only ever concealment. If the party quoting you cannot name the legal manufacturer and the specific manufacturing site, you have no way to reconcile the COA, the GMP evidence or the regulatory filing to the material in the drum. [Source: FDA guidance for industry, Drug Master Files]
What documentation should you request before a bulk tadalafil API order?
The minimum evidence file
- Full API specification, with the pharmacopoeial reference (USP, EP or BP) stated
- Batch-specific Certificate of Analysis showing batch number, methods, acceptance criteria and actual results
- GMP evidence naming the exact manufacturing site, not the corporate head office
- Safety Data Sheet
- Stability data and the retest or expiry date for the offered batch
- DMF, USDMF, ASMF or CEP support where the destination market requires it
- The Letter of Authorization process, in writing
- Export documentation set for the intended route
DMF, USDMF, CEP and COA, defined
Drug Master File (DMF). A confidential submission to FDA describing a facility’s processes, controls and materials. It exists so a drug applicant can reference the information without the holder disclosing it. Critically, FDA neither approves nor disapproves DMFs, so a DMF number is not a stamp of approval. [Source: FDA guidance for industry, Drug Master Files]
Certificate of Suitability (CEP). An EDQM certification that the relevant European Pharmacopoeia monograph is suitable for controlling the quality of that substance from that holder, under the certified conditions. A CEP is not a DMF by another name, and it is not evidence of acceptance in every market. [Source: EDQM, Certification of Suitability background and legal framework]
Certificate of Analysis (COA). A batch-level test record. A “representative” or “typical” COA tells you what the site can produce on a good day. Only a batch-specific COA tied to the batch you are buying tells you what you are actually receiving.
Why the Letter of Authorization matters more than the DMF number
A DMF you cannot reference is of no use to your filing. The holder must issue a Letter of Authorization permitting FDA to review the DMF in support of your specific application. If a supplier quotes a DMF number but cannot identify the holder or describe how an LOA would be issued, treat the filing claim as unverified until proven otherwise. [Source: FDA guidance for industry, Drug Master Files]
What do US buyers specifically need to import tadalafil API?
US requirements are narrower than most global supplier pages imply, and a supplier can satisfy every non-US credential while still failing them.
- Foreign facility registration. The manufacturing establishment must be registered with FDA under 21 CFR Part 207 and must list its known importers. [Source: 21 CFR Part 207]
- An active USDMF, where you are filing. If the API supports an ANDA or NDA, you will normally need an active USDMF plus an LOA to reference it. [Source: FDA guidance for industry, Drug Master Files]
- No such thing as an FDA registration certificate. FDA does not issue or recognise third-party “FDA registration certificates.” A supplier presenting one as proof of approval has told you something important about itself. [Source: FDA, Is It Really FDA Approved?]
- DSCSA scope. Bulk drug substance is outside the Drug Supply Chain Security Act’s package-level transaction-tracing requirements, which apply to finished dosage products moving through the pharmacy distribution chain. Do not accept DSCSA serialisation as an API quality credential. [Source: FDA, Drug Supply Chain Security Act]
- Compounding buyers, check the bulks lists. Outsourcing facilities and 503A pharmacies must confirm the substance’s standing under the applicable bulk drug substances provisions before compounding with it. [Source: FDCA sections 503A and 503B; FDA bulk drug substances nominations]
WHO-GMP certification from CDSCO, or EU-GMP, or a CEP, are all meaningful credentials in their own markets. None of them substitutes for the US requirements above. A site can hold WHO-GMP certification and still have no FDA registration and no active USDMF.
Patent and exclusivity status is a separate check from quality. Generic tadalafil has been marketed in the US since 2018, but buyers should confirm the current position for their specific product, strength and indication in the FDA Orange Book rather than relying on a supplier’s assurance. Some suppliers explicitly offer patented products for research purposes only, which is a materially different commercial basis. [Source: FDA Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations]
Why is India the dominant sourcing base for tadalafil API?
Filing data tells the story more reliably than marketing does. Industry databases tracking tadalafil list well over a hundred API suppliers globally, with roughly two dozen US Drug Master Files on record. India accounts for the largest share of those filings, followed by China, with single filings from Poland, Israel, Canada and the United States. [Source: PharmaCompass tadalafil USDMF listing, accessed August 2026]
Those counts move as filings are added, deactivated or reviewed under GDUFA, so treat any figure you read (including this one) as a snapshot and verify current status directly. The structural point is stable: India has depth of qualified capacity for this molecule, which matters for second-source strategy and for negotiating position.
Depth of capacity is not the same as uniform quality. The same market that gives you multiple EU-GMP and USDMF-holding sites also gives you a long tail of intermediaries positioned to look like those sites.
What technical specifications belong on your RFQ?
A vague RFQ produces a vague quote, and later a dispute. For a tadalafil tablet program, specify at minimum:
| Parameter | Why it matters downstream |
|---|---|
| Particle size distribution | Content uniformity, blend behaviour and dissolution in a low-dose tablet |
| Polymorphic form | Solubility, dissolution profile and physical stability over shelf life |
| Related substances and impurity profile | Monograph compliance and impurity qualification in your filing |
| Residual solvents | ICH Q3C class limits, and a signal about the synthetic route used |
| Water content | Assay calculation basis and stability |
| Microbiological limits | Required where your dosage form or market expects it |
| Retest date and batch age | A cheap quote is often an old batch with a short remaining window |
| Packaging | Commonly 25 kg HDPE drums with double LDPE liners; sample packs vary by site |
Which supplier red flags should disqualify a vendor?
Stop the qualification process if you see any of these
- A DMF or CEP is claimed, but the holder identity, filing route or LOA process cannot be produced.
- An “FDA registration certificate” is offered as proof of approval.
- The quoted price is far below market with no explanation of batch age, retest date, MOQ or document scope.
- The bank beneficiary does not match the contracting party, and the change is not independently verified.
- Payment is pressed for before sample review or document reconciliation.
- The named manufacturing site shifts between the COA, the GMP certificate and the invoice.
- Packaging, storage or shipping terms stay vague for what is a regulated pharmaceutical shipment.
The beneficiary mismatch deserves particular attention. Payment redirection fraud against pharmaceutical buyers usually arrives as a plausible mid-transaction banking update, and the losses are rarely recoverable. Verify any change through a channel you already had, not one supplied in the email requesting the change.
What clinical and safety facts should your regulatory team hold in view?
Even when your role stops at the drug substance, the finished product’s safety profile shapes labelling, pharmacovigilance commitments and market authorisation questions. The following is drawn from US approved labelling and is provided for regulatory context, not as treatment guidance.
Who should not take tadalafil: contraindications
- Anyone using any form of organic nitrate, regularly or intermittently. Tadalafil potentiates the hypotensive effect of nitrates, and co-administration is contraindicated.
- Anyone using a guanylate cyclase stimulator such as riociguat, because of potentiated hypotensive effects.
- Anyone with known serious hypersensitivity to tadalafil. Reactions including Stevens-Johnson syndrome and exfoliative dermatitis have been reported.
- Anyone for whom sexual activity is inadvisable on cardiovascular grounds.
Use with caution: with alpha-blockers, other antihypertensives, or substantial alcohol (5 units or more), any of which may lead to hypotension. Combination with alpha-blockers is not recommended for BPH treatment. Caution also applies where a patient is predisposed to priapism, for example sickle cell anaemia, multiple myeloma or leukaemia, or has anatomical deformation of the penis.
Renal impairment: for creatinine clearance below 30 mL/min or haemodialysis, as-needed dosing should not exceed 5 mg every 72 hours, and once-daily use is not recommended.
Emergency nitrate use: where nitrate administration is judged medically necessary in a life-threatening situation, the label advises at least 48 hours should elapse after the last tadalafil dose, and then only under close medical supervision with haemodynamic monitoring.
[Source: FDA prescribing information, CIALIS (tadalafil) tablets, Contraindications, Warnings and Precautions, and Drug Interactions sections]
US labelling for tadalafil does not carry a boxed warning. That absence should not be read as an absence of risk, and it is not a safety claim. [Source: FDA prescribing information, CIALIS]
Common adverse reactions
The adverse reactions reported most frequently in clinical trials include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing and pain in the limb. Less common but clinically significant events described in labelling include prolonged erection and priapism, sudden decrease or loss of vision (reported in association with non-arteritic anterior ischaemic optic neuropathy), and sudden decrease or loss of hearing. [Source: FDA prescribing information, CIALIS, Adverse Reactions section]
How do counterfeit and adulterated products affect legitimate buyers?
Tadalafil is among the substances most frequently found undeclared in so-called “natural” or herbal sexual enhancement products sold online. FDA has issued repeated public notifications about tainted products in this category, in which a prescription PDE5 inhibitor is present but not listed on the label. [Source: FDA, Tainted Sexual Enhancement Products public notifications]
Claims that a supplement contains “natural tadalafil” are not supported. Tadalafil is a synthetic small molecule and a prescription drug. A product marketed as a dietary supplement that in fact contains it is adulterated, and a consumer taking it has no way of knowing they are receiving a drug that is contraindicated with nitrates.
For a legitimate bulk buyer, this has two practical consequences. First, expect and welcome KYC scrutiny from serious suppliers about your manufacturing authorisation and intended use, since a supplier that does not ask is a supplier that also does not ask others. Second, keep documented chain of custody from the manufacturing site through to your own goods-in, because that record is what distinguishes your supply chain from the diversion channel if either is ever examined.
When to see a doctor
This page is written for commercial and regulatory readers, but if you are a patient or a caregiver who has arrived here, seek prompt medical attention for any of the following while taking tadalafil:
- Chest pain or anginal symptoms, which require immediate medical attention
- An erection lasting longer than four hours
- Sudden loss or decrease of vision, in one or both eyes
- Sudden loss or decrease of hearing, with or without tinnitus or dizziness
- Signs of a serious skin reaction, such as blistering or peeling
[Source: FDA prescribing information, CIALIS, Patient Counseling Information]
Frequently asked questions
Who manufactures tadalafil API?
More than a hundred companies list tadalafil API globally, with manufacturing sites concentrated in India and China and a smaller number in Europe, Israel, Canada and the United States. The number that hold an active US Drug Master File is far smaller, so the practical shortlist depends on your destination market and filing route. [Source: PharmaCompass tadalafil API and USDMF listings, accessed August 2026]
Why is tadalafil contraindicated with nitrates?
Both act on the same vasodilatory pathway. Nitrates raise cGMP by releasing nitric oxide, while tadalafil raises it by inhibiting its breakdown, and the combination can produce a severe drop in blood pressure. US labelling therefore contraindicates tadalafil with any form of organic nitrate. Because of the roughly 17.5 hour half-life, the label advises at least 48 hours between the last tadalafil dose and any medically necessary nitrate administration, under close supervision. [Source: FDA prescribing information, CIALIS]
Is a DMF the same thing as FDA approval?
No. A Drug Master File is a confidential submission that lets a drug applicant reference a facility’s information without it being disclosed. FDA neither approves nor disapproves DMFs. A DMF number alone tells you a filing exists, not that the material is acceptable for your application. [Source: FDA guidance for industry, Drug Master Files]
What is the difference between a DMF and a CEP?
A USDMF supports a US filing pathway and is referenced through a Letter of Authorization. A CEP is an EDQM certificate indicating that the relevant European Pharmacopoeia monograph is suitable for controlling that substance from that holder under certified conditions. They serve different frameworks, and holding one does not imply the other. [Source: FDA guidance for industry, Drug Master Files; EDQM certification framework]
Can an individual buy tadalafil API?
No. Tadalafil is a prescription-only medicine and bulk API is supplied only to licensed manufacturers, CDMOs, importers, distributors and research institutions with a lawful purpose in the destination market. Bulk drug substance is not a consumer product, and it is not suitable for self-administration in any form.
How much does bulk tadalafil API cost?
Price depends on the manufacturing site, grade and monograph, order quantity, documentation scope, batch age and destination market. Any single published figure is close to meaningless without those variables attached, which is why a quote should always be requested against a defined specification rather than a product name.
Are “natural tadalafil” supplements a legitimate alternative?
No. Tadalafil is a synthetic prescription drug, so a supplement cannot contain a natural form of it. Products in this category that do contain tadalafil contain it as an undeclared adulterant, which FDA has flagged repeatedly through public notifications on tainted sexual enhancement products. [Source: FDA, Tainted Sexual Enhancement Products public notifications]
Working with a sourcing partner
The difference between a good tadalafil API sourcing outcome and a bad one is rarely price. It is whether the manufacturer, site, specification, batch evidence and regulatory support all reconcile to the same material before money moves.
Define the grade and monograph you need, the destination market, the documentation package your filing requires, the quantity and the delivery window. Then evaluate suppliers against that brief rather than against their own marketing. Ask for a qualification sample with a batch-specific COA before committing to a commercial quantity.
Disclaimer. This article is for informational purposes only and is not a substitute for professional medical advice. Consult your doctor before starting, stopping, or changing any medication.
References
- US Food and Drug Administration. CIALIS (tadalafil) tablets, full prescribing information. Drugs@FDA.
- US Food and Drug Administration. ADCIRCA (tadalafil) tablets, full prescribing information. Drugs@FDA.
- US Food and Drug Administration. Guidance for Industry: Drug Master Files.
- US Food and Drug Administration. 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing.
- US Food and Drug Administration. Drug Supply Chain Security Act (DSCSA) programme materials.
- US Food and Drug Administration. Tainted Sexual Enhancement Products, public notifications.
- US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- European Directorate for the Quality of Medicines and HealthCare. Certification of Suitability, background and legal framework.
- American Urological Association. Erectile Dysfunction: AUA Guideline.
- European Association of Urology. Guidelines on Sexual and Reproductive Health.