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 need...