Symbiotica Specialty Ingredients

Symbiotica Speciality Ingredients, as a Malaysian based manufacturer of Active pharmaceutical ingredients (API), following the Pharmaceutical Inspection Cooperation Scheme (PIC/S, Geneva) - ICH Q7 GMP Guidelines.  Established since 2001, our cGMP certified facility is based in Kulim, Kedah with a capacity of 10 mts/annum for steroidal products and 20 mts/annum for non-steroidal products - with a versatility to synthesize Gram-to-Kilograms-to-Tonne levels. Our facility is successfully inspected by the US FDA, Japanese PMDA & COFEPRIS Mexico besides routine inspections by our NPRA, a PIC/S member authority.

Please note our regulatory status as given below.

Symbiotica holds CEPs and has filed US DMFs for APIs:

* European Directorate for the quality of medicines - Certificate of Suitability (COS/CEP) for 11 APIs:

BETAMETHASONE VALERATE, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SODIUM PHOSPHATE, CLOBETASOL PROPIONATE, DEXAMETHASONE SODIUM PHOSPHATE, EXEMESTANE, MOMETASONE FUROATE ANHYDROUS, MOMETASONE FUROATE MONOHYDRATE, PREDNISOLONE ACETATE, TESTOSTERONE PROPIONATE, TIBOLONE

* US DMFs filed:
BETAMETHASONE VALERATE, BETAMETHASONE DIPROPIONATE, CLOBETASOL PROPIONATE, DEXAMETHASONE SODIUM PHOSPHATE (GDUFA IN PROGRESS), EXEMESTANE, HALOBETAOL PROPIONATE , HYDROCORTISONE VALERATE (GDUFA REFERENCED), MOMETASONE FUROATE (GDUFA REFERENCED)

We have successfully carried out ASMF submissions for 3 Non-pharmacopoeia APIs in the EU region. The manufacturing site undergoes regular audits by clients and independent audit agencies. Significant clients include major MNCs, International Generic companies and Independent 3rd party audit agencies.

Our products are exported to over 70 countries worldwide consisting of regulated, semi-regulated, partially regulated and non-regulated markets. All our products are updated to comply with specifications as listed in the monographs of latest pharmacopoeia. For non-pharmacopoeia products we file our own INN specs & validate the same. Products are presented in securely packed pharmaceutical grade, DMF supported, EU made HDPE containers. Special storage or transportation conditions are followed as per relevant needs. We follow GDP as...