Symbiotica Speciality Ingredients

We are pleased to refresh you on SYMBIOTICA as a Malaysian manufacturer of Active pharmaceutical ingredients, following the ICH Q7A GMP Guidelines, established since 2001. Our cGMP certified facility is based in Kulim, Kedah with a capacity of 3 mts./annum for steroidal products. An expansion due for completion by 2010 would increase our capacity to 10 mts in order to accommodate larger batches and increasing volume of the newer products. Separately we shall have a capacity for the non-steroidal products at 20 mts/annum. Our regulatory affairs team is well versed with international requirements of different regions. We have filed CTDs for many of our products. * We hold COS/CEP for DEXAMETHASONE SODIUM PHOSPHATE & BETAMETHASONE VALERATE * We have applied for CEP for CLOBETASOL PROPIONATE & MOMETASONE FUROATE * We have scheduled CEP applications for BETAMETHASONE DIPROPIONATE, TIBOLONE, BETAMETHASONE SODIUM PHOSPHATE, BECLOMETHASONE DIPROPIONATE in 2010- 11 * We have filed US-DMF for CLOBETASOL PROPIONATE and in the process of submitting another 15 US DMFs ( Inclusive of the above and other products ) during 2010-11. * We have carried out Closed file submissions for specific products with different ministries in the EU and Canada in relation to precise customer based projects. We diligently follow current ICH Guidelines with respect to Regulatory foundations for our products in terms of Impurity & residual solvent profiling, validations, Stability studies etc. are carried out in compliance with current ICH requirements. We have a talented R&D team which has managed to design non-infringing process for some of our products such as EXEMESTANE. Besides regular development, we also carry out process improvisation and synthesis of impurity substances. Our products are exported to over 40 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-pharmacopoeial products we file our own ***** 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. Customized processing such as Micronization, Sterilization etc are carried out against specific needs. Malaysian government has recognized us through Performance Awards, Pioneer status etc. We hope all the information above would provide you a rationale to consider us to be an able & potential SYMBIOTIC partner for you. Please be assured of a satisfactory association with high standards of professionalism, ethics, integrity and confidentiality.