TL;DR
A steroid API RFQ should require seven matched answers from every supplier: exact molecule and specification, US program, release and impurity data, manufacturing evidence, regulatory documents, quantity and packaging, and change-control terms. This checklist lets procurement and quality teams compare complete offers instead of selecting on unit price before the material and evidence match.
Use the 7-part steroid API RFQ below. It makes every supplier quote the same molecule, US documentation path, release tests, packaging, delivery schedule, and change terms.
Send the request before comparing prices. A lower unit price is not comparable when the supplier quoted a different ester, specification, manufacturing site, or document package.
Copy This Steroid API RFQ
Send this text to each shortlisted supplier. Keep every section in the supplier’s reply.
Subject: RFQ for Steroid API Supply to a US Program
Please quote the exact material below. State when a requested item is unavailable.
Do not substitute the API form, manufacturing site, specification, or package.
1. Molecule and Intended Use
API name, chemical form, and CAS number:
State the base, salt, ester, hydrate, and stereochemical form where relevant.
Intended finished dosage form:
State the planned dosage form and whether the material supports development,
commercial manufacture, or another documented use.
US program:
State whether the material is for commercial import, IND, NDA, ANDA,
compounding, or another route.
Required quality standard:
Provide the applicable compendial standard or the attached approved specification.
State the specification title, revision number, and effective date.
Substitution policy:
Confirm that no substitution will occur without written approval.
2. Release Tests and Impurity Expectations
For each requested test, provide the method or reference, acceptance criterion,
and numerical result available for representative batches:
- Identity
- Assay, including calculation basis
- Related substances, including specified, unspecified, and total impurities
- Residual solvents relevant to the proposed route
- Water content
- Particle size, polymorph, microbial, endotoxin, or elemental-impurity tests
when required for the molecule or dosage form
Provide the current specification, representative batch CoAs, and available
chromatograms or trend summaries under a confidentiality agreement.
3. Manufacturing and Quality Evidence
Supplier role:
State whether you are the original manufacturer, distributor, repacker, or relabeler.
Original manufacturer:
Provide the legal name and complete manufacturing-site address.
Other sites:
Identify any repacking, relabeling, testing, storage, or release sites.
Quality evidence:
Provide current GMP evidence for the proposed site, including the issuing authority,
scope, and date. State the most relevant inspection date and outcome.
Steroid controls:
State whether the API uses shared equipment. Describe the available containment,
segregation, cleaning-validation, and cross-contamination evidence.
Traceability:
Describe the batch traceability chain from original manufacturer to delivery.
4. US Import and Filing Support
Commercial import:
Provide FDA establishment-registration and API-listing information for the proposed
foreign manufacturing site, where applicable.
Filing support:
For an IND, NDA, or ANDA program, provide the Type II DMF holder, DMF number,
DMF subject, exact API form, covered manufacturing site, current status, and
Letter of Authorization process.
Buyer-facing quality package:
List the non-confidential specifications, methods, impurity controls, stability data,
and manufacturing-control information available for review.
5. Quantity, Packaging, and Delivery
Development or sample quantity:
Initial commercial quantity:
Annual forecast and expected order cadence:
Minimum order quantity:
Normal batch size:
Container configuration:
State inner liner, outer pack, tamper evidence, and net weight per container.
Storage and transport:
State label requirements, storage conditions, retest or expiry date, and transport controls.
Timing:
State manufacturing lead time, release-testing lead time, and delivery lead time
to the named US destination.
Commercial terms:
State quote validity, Incoterm, freight treatment, insurance treatment, payment terms,
and all separate documentation or regulatory charges.
6. Change Control and Supply Continuity
Confirm whether these terms can be included in a quality or supply agreement:
- Written notice before changes to starting materials, route, process, site, equipment,
specification, analytical method, packaging, storage, subcontractors, or impurity controls
- Proposed notice period
- Change impact assessment and supporting comparability, validation, stability,
and regulatory documentation
- Named contacts for deviations, out-of-specification investigations, complaints,
recalls, and filing-support questions
- Capacity commitment, forecast process, continuity approach, and shortage notice
7. Quote Format
Provide one line for the exact API above. Separate:
- API unit price
- Release-testing charges
- Packaging charges
- Freight and insurance
- Documentation, DMF, or Letter of Authorization charges
- Minimum-order conditions
- Assumptions, exclusions, and exceptions
For imported commercial APIs, FDA requires foreign establishments that manufacture, repack, relabel, or salvage the API to register and list commercially distributed APIs. FDA import rules
For a filing-supported program, a Type II Drug Master File can cover a drug substance or intermediate. A DMF is not approved or disapproved by FDA. FDA reviews its technical content when an IND, NDA, ANDA, or another authorized submission references it. FDA DMF guidance
Name the Exact Steroid Before You Ask for Price
Write the full API name, chemical form, and CAS number in the first line. “Testosterone” is not enough when the program requires a particular ester, base, or other defined form.
Attach the approved specification, or state the compendial standard and revision. FDA Q7 defines a specification as the tests, methods, and acceptance criteria that determine whether a material is acceptable for its intended use. FDA Q7 specification
Name the US program too. A commercial-import request needs different evidence from an ANDA-supported request. A compounding request needs its own regulatory review under the applicable route.
Ask for Results, Not a Purity Claim
Ask suppliers to state each release test, method, acceptance limit, and numerical result. FDA Q7 says an API CoA should list tests performed, acceptance limits, and numerical results when those results are numerical. FDA Q7 CoAs
Put a quotation into technical clarification when it lacks all three of these items:
- The current specification revision.
- A representative batch CoA.
- The assay calculation basis.
Assay and chromatographic purity are different measurements. An assay result can be reported on an as-is, dried, or anhydrous basis. Your quality team needs the stated basis before it compares batches or calculates API quantity.
Ask for related-substances data, residual-solvent controls, water content, and any dosage-form-specific requirements. FDA Q7 requires API specifications to control organic impurities, inorganic impurities, and residual solvents. FDA Q7 impurity controls
Use our steroid API CoA review checklist when the supplier sends batch documents. It helps QA compare the certificate with the specification and physical shipment.
Request Steroid-Specific Containment Evidence
Certain steroids require more than a general GMP certificate. FDA Q7 says manufacturers should consider dedicated production areas for certain steroids with high pharmacological activity or toxicity unless validated cleaning or inactivation procedures are established and maintained. FDA Q7 containment
Ask whether the proposed API uses shared equipment. Then request the available containment rationale, equipment flow, cleaning-validation summary, residue limits, sampling approach, and routine verification records.
The request is molecule-specific. It does not assume every steroid needs dedicated equipment. It asks the supplier to show how the proposed material is controlled at the actual site.
Separate Import Documents from Filing Support
A commercial-import quote should identify the original manufacturer, full site address, supplier role, registration and listing evidence, current GMP evidence, specification, CoA, and batch traceability.
A filing-supported quote needs extra fields. Ask for the DMF holder, DMF subject, covered site, exact API form, current status, and the Letter of Authorization process. A Letter of Authorization permits FDA to review specified DMF information for the named applicant. FDA authorization process
Do not treat a CEP as a substitute for a US DMF. A Certificate of Suitability addresses European Pharmacopoeia suitability, while a Type II DMF supports confidential information for a US regulatory submission.
Compare Quotes in Three Passes
Start with the identity gate. Compare only quotations that name the same API form, specification, manufacturing site, and intended US route.
Next, run the evidence gate. Mark whether each supplier supplied the requested specification, CoA, GMP evidence, import or filing information, impurity package, and change-control commitment. Keep missing items visible beside the price.
Finish with the commercial gate. Add API price, release testing, packaging, freight, insurance, documentation charges, minimum order, and delivery lead time. That produces a purchase comparison that procurement, QA, and regulatory affairs can approve from the same file.
For a fuller supplier review after the RFQ, use our US steroid supplier qualification guide.
FAQs
Can a Distributor Answer a Steroid API RFQ?
Yes, when the distributor identifies the original manufacturer and preserves batch traceability. FDA Q7 says the manufacturer’s name and address should be known when the supplier of a critical material is not its manufacturer. FDA Q7 traceability Ask the distributor to disclose every repacking, storage, testing, and transport handoff.
What Should I Do When One Supplier Quotes “99% Purity”?
Ask for the assay method, calculation basis, related-substances method, specification limit, and batch result. A purity percentage alone does not tell you the API content available for formulation. Compare the supplier’s complete release package against your approved specification.
When Should I Request a Sample Instead of a Commercial Batch?
Request a sample when the project needs method work, formulation screening, or incoming-test evaluation. Request a commercial quote at the same time when the program has a defined forecast and target launch path. Keep sample packaging, specification, and source identity aligned with the material you intend to qualify.
At Aarise Pharma, we help B2B buyers discuss API availability, analytical documentation, manufacturing-source details, and supply requirements for the exact material in their RFQ. Start with our US steroid raw material catalog, then send the completed request for a product-specific sourcing discussion.
