Suppliers / Symbiotica Speciality Ingredients Sdn.Bhd

Symbiotica Speciality Ingredients Sdn.Bhd

Malaysia 93 employees Updated 9 July 2026

Symbiotica Speciality Ingredients Sdn.Bhd is a contract manufacturer based in Malaysia. It holds 7 active US drug master files across a filed portfolio of 10 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 16 May 2025 as VAI.

7
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 16 May 2025 VAI US FDA
  • 10 October 2019 NAI US FDA
  • 15 September 2017 VAI US FDA
  • 10 July 2014 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Malaysia, Malaysia 3006464546

What they file, and where

Molecule Regulators Docs
Dexamethasone SFDA (Saudi Arabia), US FDA 2
Prednisolone SFDA (Saudi Arabia) 2
Betamethasone US FDA 1
Betamethasone Dipropionate SFDA (Saudi Arabia) 1
Calcipotriol SFDA (Saudi Arabia) 1
Clobetasol Propionate US FDA 1
Exemestane US FDA 1
Halobetasol Propionate US FDA 1
Hydrocortisone US FDA 1
Mometasone Furoate US FDA 1

Also appears on these molecule pages

Beclomethasone contract manufacturing Betamethasone contract manufacturing Budesonide contract manufacturing Clobetasol contract manufacturing Dexamethasone contract manufacturing Hydrocortisone contract manufacturing Mometasone contract manufacturing Norethisterone contract manufacturing Prednisolone contract manufacturing Testosterone contract manufacturing Triamcinolone contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 16 May 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates