LIBRARY · MASTER DOSSIERSSYNTHETIC DATARA LEAD · DRUG
Master Dossier Library
One master per molecule, strength, dosage form and manufacturer, built at NPD stage and replicated per market.
Provastide + Solufexin 0.5/0.4 mg
NPI-2291 · CAPSULE · OUTSOURCED
Provastide softgel + solufexin pellets in a hard capsule
Supplier pack, dossier audit closed
M1
12
M2
46
M3
188
M4
—
M5
72
MARKET COVERAGE90%
Vietnam, Philippines, Peru, Ethiopia
Vildaglin 25 mg tablets
NPI-1996 · TABLET · OUTSOURCED
Film-coated tablet, one strength per idea
Formula changed by manufacturer — new registration in two markets
M1
10
M2
34
M3
121
M4
6
M5
28
MARKET COVERAGE64%
Vietnam, Nigeria, Kenya, Tanzania
Vitamin E Softgel 400 IU
NPI-1874 · SOFTGEL · IN-HOUSE
Softgel capsule, Bangkok facility
In-house R&D — every document generated and reviewed internally
M1
9
M2
31
M3
104
M4
8
M5
24
MARKET COVERAGE81%
Peru, Kenya, Tanzania, Uganda
Ostebrix 60 mg/mL
NPI-2340 · DRUG-DEVICE · PARTNER
Pre-filled syringe — biologic with a device constituent
Two authorities per market; site registration in parallel
M1
14
M2
22
M3
61
M4
12
M5
—
MARKET COVERAGE46%
Vietnam, Thailand
Registration Identity Rules
Mega's numbering logic, carried into the platform unchanged.
NPIEOne idea per molecule, strength, dosage form and manufacturer. Change the manufacturer and a new idea opens.
NPDOne development project per idea — in-house generates documents, outsourced uploads the supplier pack.
NPROne registration project per market, per registration type and per packaging configuration. 3x10 and 10x10 are separate registrations.
NPLOne launch per market and product, raised after approval so supply chain can issue the PO.
REVA new market joins through an idea revision — financial evaluation and cross-functional inputs run again for that market.
How Dossiers Are Held Today
The initial supplier dossier is saved to SharePoint, gaps go into an additional-documents folder, links are built in Acrobat and shared with the market. Work often sits on a laptop and never gets uploaded, so nobody can tell what exists. Many pages are signed scans — no text to search until OCR runs.
FORMATS SEEN
Word · native PDF · signed scan
ON INTAKE
OCR, bookmark, hyperlink
ANY EDIT
Back to supplier for sign-off
HELD IN
SharePoint, Acrobat, laptops
Master Dossier Index · Solufexin 0.4 mg MR capsules
318 documents under CTD headings, versioned on intake. Counts include every supplier block replicated per active ingredient.
SECTION
TITLE
DOCS
LATEST VER
SEARCHABLE
STATE
1.0
Administrative & product information
24
v4
100%
COMPLETE
2.3
Quality overall summary
6
v3
100%
COMPLETE
3.2.S
Drug substance — replicated per API supplier
71
v6
94%
3 SUPPLIERS
3.2.P
Drug product — formulation, container, controls
96
v5
97%
COMPLETE
3.2.P.8
Stability — long term, accelerated, zone-specific
38
v3
88%
ZONE 4B GAP
3.2.R
Regional information — batch records, validation
42
v2
61%
OCR RUNNING
4.2
Non-clinical study reports
19
v1
100%
COMPLETE
5.3
Clinical study reports — BE study
22
v2
100%
COMPLETE
Intake Queue
What the platform is reading right now. A pack lands as scans; classification, bookmarking and hyperlinking finish before anyone opens it.
Norvexa supplier pack — Nov releaseCLASSIFYING
214 scanned pages across 31 files. Bookmarks and section hyperlinks being written.
154 / 214 pages~6 min left
Zenaflozin 10 mg — batch validation setOCR
Signed and stamped scans. Four pages flagged unreadable rather than guessed.
88 / 190 pages~14 min left
Kaviro DMF — open partINDEXED
Mapped to 3.2.S for two products. Closed part remains with the supplier by agreement.
118 pagesdone 09:14
Provastide artwork set — five marketsHELD
Native files missing; only flattened PDFs supplied. Cannot version text layers.
12 / 54 pagesblocked on supplier
Nexoprazil legalised certificatesINDEXED
Apostille pages linked to the certificates they authenticate.
26 pagesdone 08:41
Duplicate & Supersession Findings
Same document, three folders, two versions. The platform names the survivor and keeps the rest linked rather than deleted.
DUPProcess validation report — 3 batchesSame report found in three folders under two names, one an earlier draft.Survivor: v3, 14 Mar. Two links kept, nothing deleted.
SUPERMethod validation — assay by HPLCv2 cited in a live submission while v3 exists unsigned.v2 remains citable until v3 is signed off.
DUPCertificate of analysis — Kaviro lot K-4402Two scans of the same certificate at different resolutions.Higher-resolution scan promoted; the other linked.
CONFLICTSpecification — finished productTwo versions disagree on the dissolution limit at 45 minutes.Escalated to RA. Both versions held, neither citable.
SUPERSite master file — Bangkok plantSuperseded by the post-audit revision issued in June.June revision is now the default for new runs.
Version History · Solufexin 0.4 mg MR
Every master version, why it moved, and which registrations were drawing from it at the time. A version is never overwritten — a filing that cited v4 keeps citing v4 after v5 exists.
v6
14 Aug 2026
Third API supplier block addedCURRENT
Sintell added as an approved source, replicating section 3.2.S a third time. The block is present but the DMF has not arrived, so it stays open.
Drawn on by 4 live registrations
v5
02 Jun 2026
Specification limit correctedSUPERSEDED
Dissolution limit at 45 minutes reconciled after two versions disagreed. RA ruled; the losing version stays linked, not deleted.
Cited by Vietnam round 1
v4
11 Mar 2026
Post-audit site master fileSUPERSEDED
Bangkok plant revision issued after the inspection, replacing the pre-audit file for all new runs.
Cited by Philippines submission
v3
28 Nov 2025
Second API supplier block addedSUPERSEDED
Kaviro open part received and mapped, doubling the drug-substance section for every downstream market.
Cited by Peru submission
v2
19 Aug 2025
Bioequivalence report attachedSUPERSEDED
Comparator sourced in-region, so no additional study was triggered for the ASEAN markets.
Cited by Vietnam original filing
v1
04 Apr 2025
Master assembled at developmentORIGIN
First complete index built from the development pack. One supplier, 214 documents, no market run yet attached.
No live citations
SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.