STATUS REPORT as of 15 June 2012 LOCAL REGISTRATION A.

APPLICATION FOR INITIAL REGISTRATION PRODUCT NAME ROUTINE SLIP NUMBER DATE SUBMITTED TO FDA 1) 5% Dextrose in 0.9% Sodium Chloride 10 DR/I-369 02 Mar 2010 Solution for IV Infusion 25 Feb 2011 (100 mL, 250 mL &500 mL PP Bottles) 24 Aug 2011 11DR/RA-284 2) 0.9% Sodium Chloride Solution for IV Infusion 10 DR/I-370 02 March 2010 (100 mL, 250 mL &500 mL PP Bottles) 02 May 2011 24 Aug 2011 11 DR/RA-284 3) Balanced Multiple Maintenance Solution with 10 DR/I- 389 03 Mar 2010 5% Dextrose (MULTISOL-M in D5W) 20 Jan 2011 (100 mL, 250 mL &500 mL PP Bottles) 20 Jul 2011 11 DR/RA-221 17 Jan 2012 13 Mar 2012 4) 5% Dextrose in Lactated Ringer's Solution 10 DR/I-388 03 Mar 2010 (100 mL, 250 mL &500 mL PP Bottles) 20 Jan 2011 20 Jul 2011 11 DR/RA-219 17 Jan 2012 13 Mar 2012 16 Mar 2010 04 Jan 2011 21 June 2011 28 Sept 2011 08 Nov 2011 28 Apr 2010 20 Jan 2011 20 Jul 2011 17 Jan 2012 06 Mar 2012

5) Balanced Multiple Maintenance Solution with 5% Dextrose (MULTI-ION MB in D5W) (250 mL &500 mL PP Bottles)

10 DR/I-572 11 DR/RA-156 11 DR/COMP-3287

Waits

6) 5% Dextrose in Lactated Ringer's Solution (100 mL, 500 mL &1000 mL PP Bags)

10 DR/I-713 11 DR/RA-220

DATE SUBMITTED TO FDA 7) Ambroxol HCl 30 mg/5 mL Syrup (COTRYN) 10 DR/I-1641 16 Sept 2010 01 Aug 2011 04 Oct 2011 11 DR/COMP-2901 31 Jan 2012 27 Mar 2012 8) Ambroxol HCl 15 mg/5 mL Syrup (COTRYN) 10 DR/I-1642 16 Sept 2010 01 Aug 2011 04 Oct 2011 11 DR/COMP-2900 31 Jan 2012 27 Mar 2012 B. APPLICATION FOR RENEWAL REGISTRATION 1) Fluocinonide 0.05% Ointment (LIDEX); 11 DR/R-619 13 Dec 2011 DR-X 2132 2) 5% Dextrose in 0.3% Sodium Chloride 12 DR/AR-647 24 Apr 2012 Solution for IV Infusion 3) 5% Dextrose in Lactated Ringer's Solution for 12 DR/AR-648 24 Apr 2012 IV Infusion

PRODUCT NAME

ROUTINE SLIP NUMBER

4) 5% Dextrose in 0.9% Sodium Chloride Solution for IV Infusion 5) Sterile Water for Irrigation 6) 5% Dextrose in Water Solution for IV Infusion 7) Peritoneal Dialysis Solution with 4.25% Dextrose (EUROPERSOL with 4.25% DEXTROSE) 8) Sterile Water for Injection 9) 10% Dextrose in Water Solution for IV Infusion 10) 0.9% Sodium Chloride Solution for IV Infusion

12 DR/AR-649 12 DR/AR-650 12 DR/AR-702 12 DR/AR-703 12 DR/AR-704 12 DR/AR-705 12 DR/AR-853

24 Apr 2012 24 Apr 2012 08 May 2012 08 May 2012 08 May 2012 08 May 2012 05 June 2012

PRODUCT NAME 1) Shelf-life extension from 24 months to 60 months Metoclopramide (as Hydrochloride) 5 mg/mL Solution for Injection (CLOPRIMED) (2 mL); DR-XY 36421 PRODUCT NAME 1) Haemodialysis Bicarbonate Concentrate (SOLUCARB BC 03-5%) 5 L &10 L 2) Haemodialysis Bicarbonate Concentrate (SOLUCARB BC 03-8.4%) 3) Lactoserum 900 mg/Lactic Acid 1 g per 100 mL (FEMCARE) with douching apparatus 4) Metoclopramide (as hydrochloride) 5 mg/mL Solution for Injection (2 mL); DR-XY 28138 5) SOLUCID AC 01-11 &SOLUCARB BC 0103.8.4% (5 L &10 L) 6) Lidex Cream, Lidex NGN, Lidemol Cream 7) Fluocinolone Acetonide 0.01% Emollient Cream (SYNALAR 10) 8) Fluocinonide 0.05% Cream (LIDEX) 9) Fluocinolone Acetonide 2 mg/g (0.2%) Cream (SYNALAR HP)

C. APPLICATION FOR SHELF-LIFE EXTENSION ROUTINE SLIP NUMBER DATE SUBMITTED TO FDA 11 DA/DR-1618 12 Jul 2011 14 Nov 2011 06 Dec 2011 11 DR/COMP-3569 D. APPLICATION: VARIOUS AMENDMENTS ROUTINE SLIP NUMBER DATE SUBMITTED TO FDA 11-8237 08 Nov 2011 11-8238 11-8239 11-10474 11 OD-145 11 OD-423 12 OD-1738 12 OD-1996 12 OD-2827 08 Nov 2011 08 Nov 2011 29 Nov 2011 06 Dec 2011 13 Dec 2011 08 Feb 2012 14 Feb 2012 28 Feb 2012

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PRODUCT NAME 10) Haemodialysis Bicarbonate Concentrate (NEPHROCARB BC 01) 11) Haemodialysis Bicarbonate Concentrate (NEPHROCARB BC 03-8.4%)

D. APPLICATION: VARIOUS AMENDMENTS ROUTINE SLIP NUMBER DATE SUBMITTED TO FDA 12 OD-3168 12 OD-3169 06 Mar 2012 06 Mar 2012

Just

Just

12) Haemodialysis Acid Concentrate (NEPHROCID AC 08) 13) Haemodialysis Acid Concentrate (NEPHROCID AC 09) 14) Haemodialysis Acid Concentrate (NEPHROCID AC 05) 15) Haemodialysis Acid Concentrate (NEPHROCID AC 02) 16) Haemodialysis Acid Concentrate (NEPHROCID AC 06) 17) Haemodialysis Acid Concentrate (NEPHROCID AC 07) 18) Haemodialysis Acid Concentrate (NEPHROCID AC 01) 19) Haemodialysis Acid Concentrate (NEHPROCARB BC 02) 20) Haemodialysis Acid Concentrate (NEPHROCID AC 10) 21) Haemodialysis Acid Concentrate (NEPHROCID AC 11) 22) Synalar Otic Solution 23) Manila Hotel Distilled Drinking Water

12 OD-4854 12 OD-4853 12 OD-4852 12 OD-4851 12 OD-4850 12 OD-4849 12 OD-4848 12 OD-4847 12 OD-4846 12 OD-4844 12 OD-4845 12 OD-7139

17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 17 Apr 2012 04 Jun 2012

PRODUCT NAME 1) Disposable Hemodialysis Blood Tubing Set 2) Haemodialysis Acid Concentrate (SOLUCID AC 01) 3) Haemodialysis Acid Concentrate (SOLUCID AC 03) 4) Haemodialysis Acid Concentrate (SOLUCID AC 04) 5) Haemodialysis Acid Concentrate (SOLUCID AC 02) 6) Haemodialysis Acid Concentrate (SOLUCID AC 10) 7) Haemodialysis Bicarbonate Concentrate (SOLUCARB BC 03-8.4%) 8) Haemodialysis Bicarbonate Concentrate (SOLUCARB BC 02) 9) Haemodialysis Bicarbonate Concentrate (SOLUCARB BC 01)

ROUTINE SLIP NUMBER 2012-406 2012-966 2012-965 2012-968 2012-969 2012-967 2012-1042 2012-1038 2012-1043

DATE SUBMITTED TO BHDT 29 Feb 2012 15 May 2012 15 May 2012 15 May 2012 15 May 2012 15 May 2012 22 May 2012 22 May 2012 22 May 2012

13 June 2012 TOP PRIORITY

PRODUCT NAME 1) Shelf-life extension from 24 months to 60 months Metoclopramide (as Hydrochloride) 5 mg/mL Solution for Injection (CLOPRIMED) (2 mL); DR-XY 36421 2) Metoclopramide (as hydrochloride) 5 mg/mL Solution for Injection (2 mL); DR-XY 28138 3) SOLUCID AC 01-11 &SOLUCARB BC 0103.8.4% (5 L &10 L) ROUTINE SLIP NUMBER 11 DA/DR-1618 11 DR/COMP-3569 11-10474 11 OD-145 DATE SUBMITTED TO FDA 12 Jul 2011 14 Nov 2011 06 Dec 2011 29 Nov 2011 06 Dec 2011

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