Before any commercial discussion, a US buyer should be able to answer these questions about a prospective pharmaceutical API manufacturing company in India.

1. Regulatory and facility credentials

• Is the facility WHO-GMP certified, and is that certification current?
• Has the site been inspected by the USFDA, and if so, what was the outcome? Request the Establishment Inspection Report (EIR) status and any Form 483 observations, along with how they were resolved.
• Is the facility ISO 9001 certified for quality management systems?
• Does the manufacturer hold approvals from other stringent regulatory authorities, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Australia’s Therapeutic Goods Administration (TGA), or the EU’s Written Confirmation scheme? A track record across multiple regulated markets is a useful proxy for documentation discipline, even when the specific approval is not one your US filing requires.
• Can they provide a current Site Master File describing the facility, equipment, and quality organization?

2. Drug Master File status

This is one of the most commonly misunderstood parts of qualification. A Certificate of Suitability to the European Pharmacopoeia (CEP) or a European Drug Master File (EDMF) is not the same thing as a US Drug Master File (USDMF), and having one does not guarantee the other exists.

• Ask directly: is there an active Type II USDMF filed with the FDA for this specific API, and what is the DMF number?
• If no USDMF exists yet, ask about the manufacturer’s willingness and realistic timeline to file one, since this materially affects how soon the API can support an ANDA submission.
• Confirm whether the DMF has been referenced successfully in any approved or pending ANDA, which is a strong signal that the documentation package has already withstood FDA review.
• Never assume regulatory equivalence between filings for different markets. Verify each one independently for the API and dosage form you actually need.

3. Quality systems and technical documentation

• Request a sample Certificate of Analysis and confirm it maps to the pharmacopeial specification you require, whether that is the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or another reference standard.
• Ask for validation packages, including Analytical Method Validation (AMV) and Process Validation (PV) data.
• Review stability data prepared under International Council for Harmonisation (ICH) Q1A guidelines, covering both long-term and accelerated conditions.
• Confirm the manufacturer follows ICH M7 principles for control of genotoxic and mutagenic impurities, and ask how impurity profiles are established and monitored batch to batch.
• Review the change control and deviation management procedures. How are process changes communicated to customers, and how far in advance?

4. On-site or remote audit

Documentation review is necessary but not sufficient. Before finalizing qualification:

• Conduct an on-site quality audit, or engage a qualified third-party audit firm if travel is not immediately feasible.
• Sample actual batch records rather than relying solely on summary documents.
• Ask specifically about any prior FDA, EMA, or other regulatory agency warning letters, import alerts, or unresolved observations at the site.
• Evaluate the manufacturer’s laboratory instrumentation and capability, such as HPLC, GC, IR, and Karl Fischer titration, since this indicates whether in-house testing can support the specifications you require.

5. Supply chain and raw material traceability

Given how much of the region’s chemistry still traces back to Chinese-origin starting materials, this step deserves its own line item rather than being folded into general due diligence.

• Map the origin of key starting materials and intermediates used to manufacture your API.
• Ask whether the manufacturer has backward integration into any of those intermediates, or whether it maintains dual or backup sources for critical inputs.
• Understand the manufacturer’s contingency plan if a key starting material supplier is disrupted.
• Confirm production capacity and lead times realistically match your forecasted volumes, including surge capacity if your program scales.

6. Export readiness and logistics

• Confirm the manufacturer’s experience exporting specifically to the United States, including familiarity with FDA facility registration requirements, proper labeling, and shipping documentation.
• Ask about DGFT (Directorate General of Foreign Trade) export recognition status in India; higher-tier export house recognition is a reasonable proxy for export volume and compliance track record.
• Clarify Incoterms, typical lead times, and whether cold chain or hazardous material handling capability is available if your API requires it.

7. Commercial and compliance safeguards

• Run standard sanctions and denied-party screening before finalizing any agreement.
• Put a signed quality agreement and confidentiality or non-disclosure agreement in place before sharing proprietary specifications.
• Get clarity on pricing structure, minimum order quantities, and capacity reservations in writing, not just verbally during initial calls.
• Confirm the applicable tariff classification for your specific product and stay current on trade policy, since exemptions such as the current generics carve-out under Section 232 can be reviewed and revised.