Bedaquiline
SimSon already publishes 43 observed catalogue products for Bedaquiline while an FDA nitrosamine acceptable-intake limit dated 13 September 2026 is already in force — a near-term SELL opportunity.Source
- TIMING
- A dated catalyst is forcing analytical work now — a novel approval, an NDSRI limit, a loss of exclusivity or a generic filing wave.
- Here: A dated catalyst scores 100/100 while SimSon already holds observed coverage.
- DEPTH
- SimSon demonstrates substantial observed public catalogue depth for the molecule.
- Here: SimSon publicly lists 43 products for this API family (threshold 20).
- ADJACENCY
- SimSon has strong adjacent coverage and a small extension would complete an attractive family.
- Here: SimSon's own published impurity series omits 3, 6, 12, 18; the gap is visible on SimSon's page.
Take coverage SimSon already has to market.
Take SimSon's existing 43-product bedaquiline coverage to market ahead of the catalyst.
First step: Identify which accounts already buy adjacent standards from SimSon.
Review the coverage evidence- Urgency
- Act now
- The catalyst is already in force — it dates from 2026-09-13, 0 months ago.
- Owner
- Not set
- Owner is not set: the system has no access to SimSon's org chart and will not guess one.
- Value — not public
- Cannot be established
- Revenue and margin are not public. This ranks the strength of the public signal, not the size of the prize — see what internal data would settle it.
Why now
Why SimSon
Observed from SimSon’s own public catalogue pages. This measures published coverage, not inventory, and it is not a statement that SimSon can synthesise any specific compound.
SimSon demonstrates adjacent public catalogue coverage: 43 products observed on its own bedaquiline API page, including 1 nitroso products and 2 isotope-labelled products. This is capability evidence; it is not a statement that SimSon can synthesise any specific compound.Source
- Total products
- 43
- Nitrosamine-related
- 1
- Isotope-labelled
- 2
SimSon publishes a numbered impurity series for this API with 3, 6, 12, 18 absent between published neighbours.
A checkable fact about SimSon’s published page, not an inference.
nitrosamine · isotope labelled · impurity standards
Organisations publicly associated with this molecule
No public filing record names an organisation for bedaquiline in the current evidence set, so no buyer-candidate is asserted.
How this decision was reached
R2_DEPTH_TIMINGSimSon already publishes a material catalogue position for this molecule and a dated catalyst is in force. The standards exist; the demand event has happened.
SimSon already holds 43 observed products and a dated catalyst scores 100/100.
This is a system recommendation, not system evidence. It was selected by a fixed rule evaluated top to bottom over the values above — no model, no judgement. Change the inputs and the rule changes with them.
SELL — rule R2_DEPTH_TIMING. SimSon already holds 43 observed products and a dated catalyst scores 100/100.
Opportunity score
- Market activity
- 9.1
- Regulatory catalyst
- 100.0
- Competitor scarcity
- Not scored
- Capability adjacency
- 100.0
- Evidence quality
- 65.8
Why competitor scarcity is not scored
Identity-grade competitor coverage was insufficient across the three suppliers this dimension requires. The 20 weight points it would have carried were removed from the denominator rather than scored as zero, so the remaining dimensions keep their relative influence.
A false competitive gap is materially worse than a missing scarcity score, so the dimension stays unscored until the evidence standard is met.
- Distinct ANDA sponsors
- 0
- Marketed products
- 2
- Distinct trial sponsors
- Not checked
ClinicalTrials.gov disallows our agent on /api/ in its robots.txt. The trial component was omitted from the weighted average rather than scored zero, and no substitute source was used.
Evidence ledger
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationFDA Orange Book data filesobserved
Orange Book patent row
N 204384 product 002
https://www.fda.gov/media/76860/download?attachmentRetrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationFDA CDER CPCA NDSRI acceptable-intake limitsobserved
N-nitroso-desmethyl-bedaquiline — Bedaquiline
N-nitroso-desmethyl-bedaquiline; parent API Bedaquiline; potency category 1; 26.5 ng/day
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cder-nitrosamine-impurity-acceptable-intake-limitsRetrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalSimSon Pharma LimitedSimSon public catalogueobserved
SimSon catalogue coverage — bedaquiline
43 products observed on https://www.simsonpharma.com/products/Bedaquiline
https://www.simsonpharma.com/products/BedaquilineRetrieved 13 SEPT 2026
What internal SimSon data would change this decision?
Everything above was built from information anyone can retrieve. The scoring is deterministic and the evidence is cited — but each of the following would sharpen this recommendation materially, and none of it is public.
Realised selling price and margin per catalogue item
Every opportunity here is ranked by signal strength, never by profit. A high-scoring molecule may be one SimSon sells at its thinnest margin.
Would be resolved by: SimSon price book and cost model
Historical RFQs and enquiry conversion
The best predictor of the next order is usually the last unconverted enquiry. None of that is public.
Would be resolved by: SimSon CRM and enquiry log
Existing customer relationships
The organisations listed as buyer-candidates may already be SimSon customers. The system has no way to tell, which is exactly why it never calls them leads.
Would be resolved by: SimSon customer master
Inventory and lead time
A listed product is not an in-stock product. A SELL recommendation assumes availability the catalogue does not state.
Would be resolved by: SimSon ERP
Actual competitor pricing, stock and terms
Public catalogues show listings, never terms. Even where a competitor listing is observed, it says nothing about price or availability.
Would be resolved by: Not public — sales intelligence or direct enquiry
competitor scarcity is NOT SCORED (0 of the 3 required suppliers hold an identity-grade verdict); the ClinicalTrials.gov trial-sponsor component is omitted from market activity because that publisher's robots.txt disallows our agent on /api/ — omitted, not scored zero; catalogue depth is capability evidence only and carries no demand claim.Source