Suppliers / Symbiotica Speciality Ingredients Sdn.Bhd

Symbiotica Speciality Ingredients Sdn.Bhd

Malaysia 93 employees Updated 9 July 2026

Symbiotica Speciality Ingredients Sdn.Bhd is an API 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 Calcipotriol API Clobetasol contract manufacturing Deflazacort contract manufacturing Dexamethasone contract manufacturing Exemestane contract manufacturing Halobetasol contract manufacturing Hydrocortisone contract manufacturing Mometasone contract manufacturing Norethisterone contract manufacturing
Show 3 more molecule pages
Prednisolone contract manufacturing Testosterone contract manufacturing Triamcinolone contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Symbiotica Speciality Ingredients Sdn.Bhd

Does Symbiotica Speciality Ingredients Sdn.Bhd hold a US DMF or a CEP?
Symbiotica Speciality Ingredients Sdn.Bhd holds 7 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Symbiotica Speciality Ingredients Sdn.Bhd FDA-registered?
One site operated by Symbiotica Speciality Ingredients Sdn.Bhd carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Symbiotica Speciality Ingredients Sdn.Bhd's last inspection go?
The most recent inspection on record closed on 16 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Symbiotica Speciality Ingredients Sdn.Bhd manufacture?
1 registered site is on record, in Malaysia (Malaysia). Every site is listed on this page with the register it came from.
What does Symbiotica Speciality Ingredients Sdn.Bhd make?
10 molecules are on record against Symbiotica Speciality Ingredients Sdn.Bhd, including Dexamethasone, Prednisolone, Betamethasone and Betamethasone Dipropionate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Symbiotica Speciality Ingredients Sdn.Bhd's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

Comparable suppliers

Curia shares 7 molecules Farmabios shares 7 molecules Symbiotec Pharmalab shares 7 molecules Henan Lihua Pharmaceutical shares 5 molecules Tianjin Tianyao Pharmaceuticals shares 5 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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