Filter active suppliers to the inspection-clean cohort. NAI / VAI / OAI joined per plant, with the recent observation count and trajectory.
Rivaroxaban carries 67 active Type II DMFs in the FDA register. Sai Sreyas Pharmaceutical, Bayer (innovator), and Dr Reddy's lead the holder list by filings. The long-tail structure (most holders carry one filing each) reflects active capacity build-out across India and China. The inspection-clean filter narrows the cohort to plants with a recent NAI classification.
| # | Holder | Region | Active DMFs | Most-recent filing | Inspection chip |
|---|---|---|---|---|---|
| 1 | Sai Sreyas Pharmaceutical | IN · Telangana | 3 active | Nov 2025 | NAI |
| 2 | Dr Reddy's Laboratories | IN · Hyderabad | 2 active | Dec 2025 | VAI |
| 3 | Bayer AG (innovator) | DE · Leverkusen | 2 active | Jul 2008 | NAI |
| 4 | Hetero Drugs | IN · Hyderabad | 1 active | Feb 2023 | VAI |
| 5 | Vasudha Pharma Chem | IN · Hyderabad | 1 active | Mar 2023 | NAI |
The API or FDF molecule and optional regional filter (e.g. India-only, or excluding plants with active OAI status).
Active DMF holders joined to FDA inspection class. NAI-only by default; toggleable to include VAI plants with a flag.
Citation-anchored brief with the inspection-clean cohort, observation counts, and a trajectory chip per plant.
NAI-only by default. VAI plants surface with a flag; OAI plants are pushed to the secondary list automatically.
Number of 483 observations over the trailing 24 months per plant. Zero-observation plants rank first.
Improving / flat / deteriorating from the last 5 inspection cycles. A flat NAI plant is preferred to a recently-improved one.
Holders whose most-recent DMF filing is older than 5 years are flagged. Stale filings are a quality signal in their own right.
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pharmagraph_query Eighteen molecules from the live warehouse · count of active FDA Type II DMFs per molecule, 2026 snapshot. Lower counts mean a tighter qualification funnel.
The inspection-clean shortlist is the pre-RFQ compliance gate. It removes plants with active enforcement issues before a buyer sees the supplier list, so the qualification work concentrates on candidates who can actually deliver. The view is api_docs joined to inspections and legal_entities. Refresh cadence is weekly.
Current FDA inspection classification of NAI (No Action Indicated) with zero 483 observations in the trailing 24 months. The strictest filter; the headline cohort. Toggleable to include VAI plants with a flag, or to extend the trailing window to 36 months.
No. VAI plants surface with a flag and remain available to the buyer at their discretion. The default headline list is NAI-only because VAI signals active issues even when minor. OAI plants are always excluded from the headline list.
Number of distinct 483 observations issued at the plant over the trailing 24 months. Each observation is one citation from the FDA inspection database. The count includes observations subsequently closed; the goal is the historical signal density.
FDA inspection class is the default. The companion analysis covers EMA, EDQM, MHRA, and PMDA inspection histories — joinable to the same supplier shortlist for a multi-regulator view.
A plant with NAI classification and an active DMF but no observable customs export shipments over the trailing 24 months. PharmaDB flags these separately because the qualified-but-not-shipping status raises operational questions before commercial commitment.
The FDA inspection database is pulled weekly. Plant inspection class trickles in over the months following the inspection cycle; PharmaDB surfaces the most-recent published classification with its date.
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