CONTROL · LIFECYCLESYNTHETIC DATARA LEAD · DRUG
Lifecycle & Standards Compliance
New registrations, variations and five-year renewals on one product identity, ending in a consolidated approved dossier.
ACTIVE NPR PROJECTS
24
New, renewal and variation
RENEWALS INSIDE 12 M
5
Five-year marketing authorisations
OPEN VARIATIONS
4
1 launch-limiting
CONSOLIDATED DOSSIERS
11
Reproducible from approved versions
NPR Projects · new, renewal and variation
One project per market and packaging configuration. Renewals and variations open their own project under the same idea.
PRODUCT · MARKET
TYPE
WBS STAGE
WAITING ON
DUE
Provastide + Solufexin · Vietnam
NEW
Dossier compilation
Zone 4B stability data
12 SEP
Provastide + Solufexin · Philippines
NEW
Dossier accepted by market
Letter of access
19 SEP
Vildaglin 25 mg · Vietnam
VARIATION
Variation package review
New formula — new registration
02 OCT
Vitamin E Softgel · Peru
NEW
Dossier compilation
Template Rev 8 approval
25 SEP
Multivitamin Softgel · Kenya
RENEWAL
Submitted to authority
GMP certificate expiry
08 OCT
Calcium + D3 · Thailand
NEW
Dossier approval
—
30 AUG
Consolidated Approved Dossier
What the supplier needs in order to manufacture to the version the authority actually approved.
01Initial dossier received from the supplier
02Query rounds revise documents — each change carries its reason
03Authority approves; approved versions are pinned
04Consolidated approved dossier generated on demand
05Shared with the manufacturer to produce to the approved version
Standards Compliance Intelligence
Manufacturer changes are assessed against the market's variation guideline. Some run beside the launch; some stop it; some become a new registration.
Batch size increasedPARALLEL
Requires re-validation, runs beside the launch without holding it.
Excipient changed for better outputNEW REGISTRATION
A new formula is a new registration in some markets — the whole project re-runs.
Manufacturing site additionLAUNCH-LIMITING
Site-bound registrations cannot ship until the variation is approved.
Renewal Runway · next twelve months
Each bar is the window between the earliest filing date the market allows and the licence expiry. Anything red has less runway than its own registration takes.
Solufexin 0.4 mg MR
Vietnam · 3 × 10
Sep 26 → Feb 27
Zenaflozin 10 mg
Philippines · 10 × 10
Nov 26 → Jun 27
Glumetrin 850 mg
Myanmar · 3 × 10
Feb 27 → Nov 27
Nexoprazil 20 mg
Peru · blister 14
Oct 26 → Mar 27
Provastide 0.5 mg
Kenya · 3 × 10
Apr 27 → Dec 27
Vildaglin 50 mg
Tanzania · 6 × 10
Jan 27 → Aug 27
Solufexin 0.4 mg MR
Uzbekistan · 3 × 10
Jun 27 → Feb 28
Comfortable runwayFile this quarterShorter than the filing takes
Licence Register
Every approved registration, its packaging configuration and the variation chain hanging off it. One row per registration, because packaging splits are separate registrations.
PRODUCT
MARKET
PACK
LICENCE
EXPIRY
VARIATIONS
Solufexin 0.4 mg
Modified-release capsules
Vietnam
3 × 10
VN-4417-26
12 Feb 27
2 open — API supplier, artwork
Solufexin 0.4 mg
Modified-release capsules
Vietnam
10 × 10
VN-4418-26
12 Feb 27
1 open — artwork only
Zenaflozin 10 mg
Film-coated tablets
Philippines
10 × 10
PH-2209-26
30 Jun 27
None
Glumetrin 850 mg
Film-coated tablets
Myanmar
3 × 10
MM-0871-27
04 Nov 27
1 closed — site addition
Nexoprazil 20 mg
Enteric-coated tablets
Peru
Blister 14
PE-5530-26
19 Mar 27
1 open — shelf-life extension
Provastide 0.5 mg
Soft capsules
Kenya
3 × 10
KE-1146-27
08 Dec 27
None
Vildaglin 50 mg
Tablets
Tanzania
6 × 10
TZ-3302-27
22 Aug 27
2 open — packaging, specification
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.