PharmaDB
Use case · Supplier Discovery & Qualification · Active FDA Type II DMF Holders v.04.2026 · refreshed monthly
Use cases Supplier Discovery & Qualification Active FDA Type II DMF Holders
Supplier Discovery & Qualification Buyer view Data · FDA Type II DMF registerData · FDA inspection feed Live

Active FDA Type II DMF Holders

Find every active Type II DMF holder for a target molecule. Joined to plant attribution, FDA inspection class, and recent shipment volume.

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Example output · semaglutide, FDA Type II DMF register, monthly refresh
88 Active Type II DMFs · semaglutide · FDA register, 2026-05
n=88 DMFs · FDA DMF register Authoritative

Semaglutide has 88 active Type II DMFs across 64 distinct holders, and the top of the leaderboard is entirely Chinese peptide manufacturers. Zhejiang Peptites, Shenzhen Jymed, and Fujian Genohope each carry four active filings. The pattern reflects the post-2024 surge in GLP-1 API capacity outside the originator.

# HolderCountryActive DMFsMost-recent filingStatus
1 Shenzhen Jymed Technology CN · Shenzhen 4 active Feb 2026 NAI
2 Zhejiang Peptites Biotech CN · Zhejiang 4 active Dec 2025 NAI
3 Fujian Genohope Biotech CN · Fujian 4 active Sep 2025 NAI
4 Sinopep-Allsino Biopharmaceutical CN · Anhui 3 active Dec 2025 VAI
5 Shenzhen Readline Biotech CN · Shenzhen 3 active May 2025 NAI
Active DMFs
88
Distinct holders
64
Chinese holders in top 10
10 of 10
First-filed during 2025
47
30 seconds

How it works

molecule losartan origin IN destination BR
01

Pick a molecule.

Type the INN. The AI agent matches against the FDA Type II DMF register and returns the active-only cohort with first-filed dates.

0 HHI 0.42 1
computed · pre-joined · anonymised
02

The AI agent joins inspections.

Each holder is joined to its inspection class (NAI / VAI / OAI) and recent compliance events at the matched plant.

brief · cited
Lane concentration · structurally concentrated
HHI0.42
Top-3 share71%
Actionqualify second source
03

Save the supplier list.

Citation-anchored brief with holder, country, DMF count, recent filing date, and inspection chip per row. Hand off to qualification.

Why a buyer runs it

The supplier universe, filtered to active and verified.

Active-only cohort.

Inactive DMFs are excluded by default. The list is the pool that can ship API tomorrow.

Filing recency surfaced.

Most-recent filing date per holder. Recently active holders matter more than dormant ones.

Geography at a glance.

Country chip per holder, inferred from filer name when address records lag. China-led peptide vs India-led small molecule is visible in one row.

Refreshes monthly.

FDA Type II DMF register is pulled monthly. Status changes (active to inactive) propagate to the next refresh.

What a real chat looks like

Type a question. The AI agent returns the holder list.

A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.

DMF holders · semaglutide
chat · saved 2 min ago
You
Show me every active FDA Type II DMF holder for semaglutide, with first-filed date, holder country, and the most recent FDA inspection classification per plant.
F
Running tool pharmagraph_query
api_docs ⋈ legal_entities ⋈ inspections · regulator=fda_us · doc_type=DMF_Type_II · status=active
F
Semaglutide has 88 active Type II DMFs across 64 unique holders. The top of the register is Chinese — every one of the top 10 holders is a Chinese peptide manufacturer, and 47 of the 88 active filings were first lodged during 2025. The supplier pool exists; the question for procurement is which holders have inspection-clean plants and trade volume to back the paper.
Top semaglutide DMF holders · by active filings
1 Shenzhen Jymed · CN 4 active · most recent Feb 2026 · NAI plant
2 Zhejiang Peptites · CN 4 active · most recent Dec 2025 · NAI plant
3 Fujian Genohope · CN 4 active · most recent Sep 2025 · NAI plant
+61 more · open in PharmaDB
Cited api_docs 88 active legal_entities 64 holders fda_inspections last 3 cycles
Ask a follow-up... ⌘ ↵
Time-to-answer

Manual workflow vs. PharmaDB.

Manual workflow
Excel · email · syndicated reports
  1. 01 Pull FDA Type II DMF register 1-2 hr
  2. 02 Filter to active status, latest snapshot 30 min
  3. 03 Resolve holder names against legal entities 3-4 hr
  4. 04 Infer holder country from filer + address 2-3 hr
  5. 05 Join inspection class and recent events 4-6 hr
Total cycle time 1-2 days per molecule
PharmaDB
The AI agent · one query · cited
One query.
Pre-joined warehouse. DMF holders, country inference, plant attribution, and inspection class are all joined at the schema layer. The AI agent returns a ranked, citation-anchored cohort.
Total cycle time Under a minute
Run it across your portfolio

How thick the active-DMF supply is, per molecule.

Twenty molecules from the live warehouse · count of active FDA Type II DMFs per molecule, 2026 snapshot.

Semaglutide deep
88 active DMFs
Sitagliptin deep
83 active DMFs
Rivaroxaban deep
67 active DMFs
Dapagliflozin deep
65 active DMFs
Empagliflozin deep
57 active DMFs
Apixaban deep
57 active DMFs
Rosuvastatin deep
54 active DMFs
Aripiprazole adequate
49 active DMFs
Ticagrelor adequate
46 active DMFs
Pantoprazole adequate
45 active DMFs
Pregabalin adequate
42 active DMFs
Sacubitril adequate
40 active DMFs
Tenofovir adequate
39 active DMFs
Linagliptin adequate
36 active DMFs
Telmisartan adequate
28 active DMFs
Sevelamer adequate
24 active DMFs
Bilastine adequate
13 active DMFs
Cefixime thin
10 active DMFs
Trastuzumab thin
0 active DMFs
Mesalamine thin
0 active DMFs
Thin · < 12 suppliers · qualify additions Adequate · 12–49 Deep · 50+ · negotiable

The Type II DMF register is the first signal of supply intent — who has filed paperwork claiming they can make this molecule for the US market. PharmaDB joins the register to plant attribution and inspection class, so the list isn’t paper alone. The underlying table is api_docs; the join is to legal_entities and inspections. Refresh cadence is monthly.

FAQ

Frequently asked

What is a Type II DMF?+

A Drug Master File of Type II is a confidential dossier filed with the FDA covering an active pharmaceutical ingredient (API). It allows ANDA filers to reference the API manufacturer without re-disclosing manufacturing details. Active status means the FDA has not received a deactivation request and the holder has not lapsed annual fees.

Why are biosimilars and biologics like trastuzumab missing from this list?+

Biologics use a different regulatory pathway (BLA / biosimilar BLA) and do not have Type II DMFs. The PharmaDB warehouse covers DMF Types II, III, IV, and V; biosimilar manufacturers surface in trade and inspection views but show zero DMF count here.

Why are most semaglutide DMF holders Chinese?+

The GLP-1 weight-loss boom drove a wave of synthetic peptide API capacity in China starting in 2023. Chinese contract manufacturers lodged the bulk of the 88 active filings; 47 were first filed during 2025 alone. Indian players are present but in the long tail.

How is the country chip inferred?+

The FDA legal-entities register often lists a US agent address rather than the manufacturer's true HQ. PharmaDB infers country from a combination of legal name patterns (city names, brand prefixes) and the address of the matched plant. Manual override flags are available in the catalog.

Does the list cover EDQM CEPs as well?+

No — this view is the FDA Type II DMF register only. The companion analysis covers EDQM Certificates of Suitability and is reachable as the Active CEP Holders page.

How often does it refresh?+

Monthly. The FDA Type II DMF register publishes monthly with first-filed dates and status. The catalog row carries a last-computed timestamp on every result page.

Run your question.

Bring the molecule, the lane, or the supplier you're sourcing this week. The AI agent runs it on PharmaDB in 30 minutes. You keep the brief.

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