Explore ingredient profiles, available FDA DMF and China CDE records, and documented company correspondences. Our focused collection has limited coverage: inspect each profile before subscribing.
Inspect the underlying evidence and reduce repeated manual sorting. Available capabilities depend on the datasets in each profile.
Review available FDA DMF and China CDE entries alongside the exact ingredient identity. Free-base and salt profiles remain separate.
Subscribers can search the available registry records and filter reported statuses within a product profile.
Inspect reported company names and the evidence behind cross-source correspondences. A name correspondence does not verify ownership, manufacturing capability or supply availability.
Check source links and snapshot dates. Subscribers can export available research datasets to CSV with source and date information.
This preview comes from an ingredient profile in the current collection. Counts describe the imported snapshot, not a live registry or a list of verified suppliers.
Up to 3 public sample records per available registry dataset.
46 records in this snapshot
Snapshot date:
Record ID: 5951
Reported company name: MERCK SANTE SAS
Reported status: Active (A)
Record ID: 11924
Reported company name: GROUPE LIPHA
Reported status: Inactive (I)
Record ID: 12647
Reported company name: USV PRIVATE LTD
Reported status: Active (A)
47 records in this snapshot
Snapshot date:
Record ID: Y20170002070
Reported company name: MERCK SANTE SAS;MERCK SANTE S.A.S.;默克制药（江苏）有限公司
Reported status: Approved for marketed formulations (A)
Record ID: Y20180000014
Reported company name: 天津太平洋化学制药有限公司;天津太平洋化学制药有限公司
Reported status: Joint review not passed (I)
Record ID: Y20180000016
Reported company name: 山东科源制药股份有限公司
Reported status: Approved for marketed formulations (A)
Registry entries do not establish product approval or supplier qualification. Company names are reported by the source; independent qualification is still required.
Open the complete ingredient profileTry the public information before deciding whether the available data fits your research.
Search by ingredient name or CAS number. Check the precise substance, including whether the profile describes a free base or a salt.
Inspect the chemical information, available dataset counts, public samples and source snapshot dates.
Choose a personal subscription to access complete available registry records, search and status filters, documented company correspondences and CSV exports.
Subscriptions unlock existing data. They do not promise records for every ingredient, continuous monitoring or real-time registry updates.
Use the public profiles to assess coverage first. Monthly and annual subscriptions provide the same data capabilities for one account.
Chemical information, coverage summaries and real data samples.
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Complete available data for one account.
$149.00 per year
Complete available data for one account.
Access covers the data currently available on APIRFQ. Check each ingredient profile for its datasets and snapshot dates before purchasing. Subscription plans renew until cancelled.
View data subscriptionsUse the data as a documented starting point for professional investigation.
Identify the exact substance and inspect the available chemical and registry information.
Organize registry references, reported statuses and source dates for further assessment by your regulatory team.
Study reported companies and documented name correspondences before independent supplier qualification.
Profiles link records to their sources and explain the matching method. Snapshot dates show what was captured; they are not a promise of live synchronization.
A DMF provides confidential manufacturing-related information to FDA. A DMF is neither approved nor disapproved; its technical contents are reviewed in connection with applications that reference it.
Read FDA DMF information“Are neither approved nor disapproved.”
— U.S. Food and Drug Administration · Drug Master Files
FDA publishes DMF lists and explains the reported status labels. APIRFQ profiles identify the source snapshot used for each dataset.
Read the FDA DMF list“A=active ; I=inactive”
— U.S. Food and Drug Administration · DMF list
Understand the current coverage and access before subscribing.
The collection currently includes Metformin and Metformin Hydrochloride. Metformin provides chemical information. Metformin Hydrochloride also includes FDA DMF and China CDE registry snapshots. The live profile list above shows the currently available collection.
No. Registry data is provided as dated snapshots. Each dataset displays its source date. Review that date and the official source before making a decision.
You can inspect chemical identity and properties, dataset coverage summaries, source links, snapshot dates and public samples where registry data is available.
Monthly and annual subscriptions unlock the complete available registry records, search and status filters, documented company-name correspondences and CSV exports for one account. A subscription does not create missing datasets or add enterprise inquiry rights.
Subscribers can export the available research datasets as CSV with source and date information from the ingredient profile. Chemical-only profiles do not imply that registry datasets or exports are available.
No. FDA states that DMFs are neither approved nor disapproved. A registry record is not standalone proof of ingredient approval, manufacturing quality or supplier qualification.
No. They document reported names and the basis for a correspondence between sources. They do not establish verified ownership, current supply availability or qualification for your market.
No. The current service provides data research access. Business inquiries are not enabled in this phase.
Start with the available profiles and public samples, then choose a subscription if the data fits your research.
Current coverage is limited. Check the source dates and datasets for your ingredient before subscribing.
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