Tadalafil API Manufacturers and Suppliers
Tadalafil API manufacturers and suppliers in India are potential sourcing partners for US pharmaceutical companies looking to qualify additional sources, support formulation programs, or strengthen API supply continuity. For a US buyer, however, selecting an Indian supplier involves more than comparing prices. The actual manufacturing site, current quality documentation, US regulatory support, Tadalafil specification, batch traceability and import requirements all need to be reviewed before commercial qualification.
This guide explains how US pharmaceutical manufacturers, importers, procurement teams and regulatory affairs professionals can evaluate Tadalafil API manufacturers and suppliers in India, with particular attention to FDA-related documentation and Type II Drug Master File (DMF) considerations.
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Quick Answer A legitimate tadalafil API manufacturer or supplier holds an active US Drug Master File, FDA foreign establishment registration, current GMP certification, and, if exporting from India, a valid manufacturing license and export NOC from CDSCO. “Manufacturer,” “supplier,” and “exporter” are not interchangeable roles, and a buyer needs to verify the specific credentials that apply to whichever one they’re dealing with. [Source: FDA Guideline for Drug Master Files; CDSCO Export NOC Guidance, 2025] |
| Who this guide is for: Licensed pharmaceutical manufacturers, formulators, and regulatory affairs professionals sourcing tadalafil API for legitimate drug manufacturing. This is not guidance for personal use; raw API is a bulk chemical, not a finished, dispensable medicine. |
Top Tadalafil API Manufacturers and Suppliers in India
The following companies are potential sourcing candidates based on the supplier information provided for this article and publicly available company or product information. They are not presented as an FDA-approved or ranked list, and inclusion does not constitute an endorsement by PharMint.
US buyers should verify current Tadalafil availability, manufacturing location, quality certificates and regulatory documentation before approving any supplier.
1. Chemox Pharma Pvt. Ltd.
Chemox Pharma is an Indian API manufacturer that publicly markets Tadalafil API and identifies Tadalafil Citrate under CAS 171596-29-5. Its published product information references IP, BP, EP and USP grades and describes manufacturing credentials associated with WHO-GMP requirements.
For a US procurement team, the useful qualification question is not simply whether Chemox lists Tadalafil. The buyer should establish which manufacturing site produces the material, which specification applies to the offered batch and what US regulatory documentation is available.
The initial supplier request should include:
- Current Tadalafil specification
- Required USP or customer-specific specification
- Current GMP certificate
- Complete manufacturing-site address
- Recent commercial-batch CoA
- Available US regulatory filing information
- Type II DMF information, if applicable
- Stability and retest information
- Packaging and storage details
The supplier’s public product information can start the sourcing process, but the controlled documents supplied during qualification should determine the final technical assessment.
2. Sun Pharmaceutical Industries Ltd.
Sun Pharmaceutical Industries is a major Indian pharmaceutical company with extensive pharmaceutical manufacturing and API capabilities.
For a US buyer considering Sun Pharma as a potential Tadalafil source, molecule-specific availability should be established directly. A company’s broad API portfolio does not by itself demonstrate that a particular molecule is currently available for third-party commercial supply from a particular facility.
The RFQ should therefore identify Tadalafil specifically and state the intended US application, required grade, expected quantity and regulatory documentation.
A procurement team should confirm:
- Current Tadalafil commercial availability
- Manufacturing facility
- API specification
- Current GMP evidence
- Applicable US regulatory support
- Type II DMF information, if available and relevant
- Batch documentation
- Commercial supply terms
This distinction between company-level manufacturing capability and molecule-specific availability prevents an otherwise strong supplier profile from being treated as proof of a current supply arrangement.
3. Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories operates a substantial API business serving international pharmaceutical markets. Its API operations include manufacturing facilities across multiple countries and regulatory capabilities supporting global pharmaceutical customers.
For a US buyer, the relevant qualification issue is the specific Tadalafil source rather than the company’s overall API manufacturing footprint.
The buyer should request:
- Tadalafil-specific availability
- Manufacturing-site identification
- Current GMP documentation
- Applicable FDA regulatory information
- Type II DMF details where relevant
- Current specification
- Recent CoA
- Stability/retest information
- Change-control and regulatory-support procedures
FDA identifies Type II DMFs as submissions that can cover drug substances, drug-substance intermediates and materials used in their preparation.
Therefore, a supplier claiming DMF support should provide information that allows the US buyer’s regulatory team to determine whether the file is relevant to the proposed product and regulatory pathway.
4. Rakshit Drugs Pvt. Ltd.
Rakshit Drugs is an Indian API manufacturing company with facilities and international pharmaceutical operations. The company publicly describes regulatory capabilities covering international markets.
For a US buyer, the qualification should connect the Tadalafil material to the specific manufacturing site and the documentation supporting that material.
The buyer can request:
- Tadalafil product specification
- Manufacturing-site details
- Current GMP certificate
- Applicable FDA registration information
- Type II DMF reference where applicable
- Recent commercial-batch CoA
- Stability and retest documentation
- Export documentation
The key question is whether the documentation supplied during qualification consistently identifies the same manufacturer, site and API. If those details do not reconcile, the buyer should resolve the discrepancy before proceeding.
5. Century Pharmaceuticals Ltd.
Century Pharmaceuticals, based in Gujarat, publicly lists Tadalafil among its API products.
For US procurement teams, a product listing is useful as an initial sourcing lead. The qualification process should then determine whether Tadalafil is currently produced at the identified facility, which grade is available and whether the documentation package matches the requirements of the US project.
A US buyer should confirm:
- Tadalafil availability
- Pharmacopoeial grade
- Manufacturing location
- Current GMP evidence
- Current specification
- Recent CoA
- US regulatory support
- Packaging and commercial supply conditions
This information gives the buyer a basis for comparing Century with other potential Indian sources without relying on generic quality claims.
6. Atom Pharma
Atom Pharma publicly lists Tadalafil API under CAS 171596-29-5 and identifies IP, BP and USP grades in its product information. Its published material also references documents such as CoA and MSDS.
For a US buyer, the next step is to obtain current controlled versions of those documents and determine whether they relate to the actual commercial material under consideration.
The qualification request should cover:
- Current Tadalafil specification
- Required grade
- Recent commercial-batch CoA
- SDS/MSDS
- GMP documentation
- Manufacturing-site information
- FDA registration information where applicable
- Type II DMF information where applicable
- Packaging and export documentation
How Should Buyers Compare Tadalafil API Suppliers?
The lowest price per kilogram should not be the first qualification criterion. A US buyer needs to establish that the material and its documentation fit the intended regulatory and manufacturing program before commercial terms can be meaningfully compared.
| Qualification area | What to request | Why it matters |
| API identity | Tadalafil, CAS 171596-29-5 | Confirms the material being quoted |
| Specification | USP or approved customer specification | Establishes technical acceptance criteria |
| Manufacturing site | Legal name and physical address | Identifies the actual source |
| GMP | Current certificate and inspection information where applicable | Supports site qualification |
| FDA registration | Applicable foreign-establishment registration information | Relevant to US import requirements |
| Drug listing | Applicable listing information | Supports regulatory/import checks |
| Type II DMF | DMF number and holder information where applicable | Supports US regulatory submissions |
| CoA | Recent commercial batch | Provides batch-specific analytical evidence |
| Impurity profile | Specification and analytical results | Supports quality assessment |
| Stability | Stability/retest information | Supports storage and retest review |
| SDS/MSDS | Current document | Supports handling and logistics |
| Packaging | Container and pack configuration | Supports shipping and storage planning |
| Change control | Supplier notification process | Protects regulatory continuity |
| Commercial terms | Price, MOQ, Incoterm and lead time | Allows comparable sourcing analysis |
FDA’s public DMF information should be used as part of regulatory verification where a DMF is claimed. Commercial teams should not rely solely on a supplier’s statement that a DMF exists.
How PharMint Can Help US Buyers Find Tadalafil API Suppliers
Once the technical and regulatory requirements are defined, the next procurement challenge is finding suppliers that fit the sourcing brief.
PharMint is a global B2B pharmaceutical marketplace connecting buyers and importers with manufacturers and exporters across APIs, intermediates, excipients, finished formulations, medical devices and bulk medical supplies. The platform’s role is supplier discovery and B2B sourcing rather than consumer pharmaceutical purchasing.
For a US buyer sourcing Tadalafil API from India, the RFQ should communicate the requirements that determine whether a supplier is relevant:
- Product: Tadalafil API
- CAS: 171596-29-5
- Grade: USP or specified customer standard
- Destination: United States
- Quantity: Purchase or annual requirement
- Regulatory: Type II DMF where applicable
- Quality: Current GMP evidence
- Documentation: CoA, specification, SDS/MSDS and applicable regulatory documents
- Packaging: Required pack configuration
- Shipping: Preferred Incoterm and US destination
- Commercial: Payment terms and quotation validity
A defined RFQ lets suppliers respond to the actual procurement requirement rather than returning a generic Tadalafil API price.
Frequently Asked Questions
What’s the difference between an API manufacturer and a supplier?
A manufacturer synthesizes the API at a GMP facility and can hold a Drug Master File. A supplier or trader resells API sourced from a manufacturer and cannot hold a DMF in their own name.
Is a GMP certificate enough to confirm a supplier is legitimate?
No. GMP certification confirms a facility met an inspection standard at a point in time; it doesn’t confirm active FDA registration or a valid USDMF, which are separate requirements.
Do I need to verify both manufacturing and export credentials?
Yes, if sourcing from India. Manufacturing/GMP/DMF status and export licensing (NOC, CoPP) are separate regulatory layers, and both need independent confirmation.
Can a trading company hold a Drug Master File?
No. Only entities with independent manufacturing capability and a running GMP production line qualify to hold a DMF.
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The Bottom Line “Manufacturer,” “supplier,” and “exporter” describe different roles with different regulatory obligations, and treating them as interchangeable is where buyers get exposed. Confirm which role you’re actually dealing with, then verify the specific credentials that role requires, independently, before engaging. |
This article is for general informational purposes for licensed pharmaceutical industry professionals and does not constitute regulatory or legal advice. Consult qualified regulatory affairs and legal counsel before engaging any supplier or referencing a DMF in a regulatory submission.
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References and Sources FDA. Guideline for Drug Master Files; Importing Active Pharmaceutical Ingredients. CDSCO. Guidance Document for Issuance of No Objection Certificate for Export, 2025. |