Our products are supported by an adequate regulatory documentation. The DMF's in support of our customers' regulatory submissions are filed with regulatory bodies all over the world, including FDA (USA), TPD (CAN), TGA (AUS), MCC (SA) and MCA (UK). As a reference we are enclosing a list of DMF provided below:

For all our products you can send as an inquiry and we will provide you with the requested information.

Products Quality US-DMF EU-DMF 2-bromo-a-ergocryptine methanesulphonate USP , Ph. Eur. + + Amoxicillin sodium+clavulanate potassium 5/ 1 LEK + Amoxicillin trihydrate+clavulanate potassium 2/1 LEK + Amoxicillin trihydrate+clavulanate potassium 4/1 LEK + Amoxicillin trihydrate+clavulanate potassium 7/1 LEK + Cimetidine hydrochloride USP + Clavulanate potassium USP , Ph. Eur. + + Clavulanate potassium+avicel 1:1 LEK + Clavulanate potassium+avicel 70/30 LEK + Clavulanate potassium+syloid 1:1 LEK + Enalapril maleate USP, Ph. Eur., Lek + + Gentamicin sulfate USP, Ph. Eur., LEK + + Lithium carbonate USP,Ph. Eur., JP, Fr. Ph. X/BP + + Lisinopril USP, Ph. Eur. + Lovastatin USP, Ph. Eur. + + Nitrooxine LEK specif.   Omeprazole LEK + + Pravastatin sodium USP, Ph. Eur. + + Simvastatin USP, Ph. Eur. + + Silver Sulphadiazine USP, LEK + + Vancomycin hydrochloride USP, Ph. Eur. + +

Mixtures of Potassium clavulanate (Avicel, Syloid, Amoxicillin sodium) are registerted with Potassium clavulanate DMF.

	Products Quality US-DMF EU-DMF Amlodipin besylate Ph. Eur + (1/2003) Omeprazole sodium Tamsulosin hydrochloride 6/2003