GOVERNMENT OF KARNATAKA DRUGS CONTROL DEPARTMENT Office of the Drugs Controller For the State of Kamataka Palace Road,Bangalore-01. No.DCD/MFG/Application Id-240 Date : 26/06/2020 To, ANUGRAHA CHEMICALS No. D-47, D-48, D-49, D-50, C-62 & C-63 KSSIDC INDUSTRIAL ESTATE, DODDABALLAPUR,, BENGALURU, Dist:Bengaluru Rural, 561203, India Sir, ‘Sub: Drugs & Cosmetics Act, 1940 and Rules 1945 —Retention of licence. Ref: 1. Your application dated 10/02/2020. 2. Challan No. CR0220021000178738, dated 10/02/2020, Rs. 2220000. With reference to the above, in view of licence retention fee deposited vide challan referred above. The licence in Form 25 granted to you bearing No. KTK/25/549/2008 , dated 04/03/2008 shall remain valid for the period 14/02/2020 to 12/02/2025. The licence shall remain valid unless it is suspended or cancelled by Licensing Authority. Yours faithfully, AMARESH ‘iieeoc tov TUMBAGI fitsiewsse Additional Drugs Controller & Licensing Authority Drugs Control Department, Karnataka.TIST OF PRODUCTS RETAINED FOR THE PERIOD 14.02.2020 TO. 13.02.2025 TO BE MANUFACTURED BY M/S, ANUGRAHA CHEMICALS, NO. D-47 TO 50, C-62.& C- § ;ALLAPUR. BENGALURU — 561. UNDER LICENCE IN FORM 25 BEARING NO. KTK/25/549/2008, DATE] ', INDUSTRIAL ESTATE, Di VIDE REF. NO. DCD/MFG/SR-681/19-20. SL Product Permission No Na Name of the Bulk Drugs ae DOMESTIC AND EXPORT 1 | DIBUCAINE USP DCDMFGSR4/15-16, Dated: 01.12.2015 DIBUCAINE HYDROCHLORIDE USP DCD/MFG/SR-44/15-16 Dated: 01.12.2015 CINCHOCAINE HYDROCHLORIDE BP DCDIMFGISR-44/15-16 Dated: 01.12.2015 CINCHOCAINE HYDROCHLORIDE Ph.Eur DCDIMFG/SR-44/15-16 Dated: 01.12.2015 ONDANSETRON HYDROCHLORIDE USP DCD/MFG/SR-44/15-16 Dated: 01.12.2015 ONDANSETRON HYDROCHLORIDE DIHYDRATE BP DCD/MFG/SR-44/15-16 Dated: 01.12.2015 | ONDANSETRON HYDROCHLORIDE IP DCD/MFG/SR-44/15-16 Dated: 01.12.2015 ONDANSETRON HYDROCHLORIDE DIHYDRATE Ph.Eur DCD/MFG/SR-44/15-16 Dated: 01.12.2015 9. | ONDANSETRON USP : DCD/MFGISR-44715-16 Dated: 01.12.2015 10. | OXYBUTYNIN CHLORIDE USP DCDIMFG/SR-44715-16 : Dated: 01.12.2015 7. | OXYBUTYNIN HYDROCHLORIDE BP DCDIMFG/SR-44/15-16 Dated: 01.12.2015 72. | OXYBUTYNIN HYDROCHLORIDE Ph Eur DCD/MFGISR-44715-16 Dated: 01.12.2015 iB DCDIMFG/SR-44/15-16 CARVEDILOL Ph.Eur Deane Te DCDIMFGSR-44715-16 eR remeeme ee Dated: 01.12.2015 5 DCDIMFG/SR-44/15-16 | SEE Dated: 01.12.2015 [16 | LOPERAMIDE HYDROCHLORIDE USP DCD/MEGISR-44715-16 | Dated: 01.12.2015 17. [LOPERAMIDE HYDROCHLORIDE BP DCD/MEGISR-44715-16 Dated: 01.12.2015 ig. | COPERAMIDE HYDROCHLORIDE Ph.Eur DCDIMFGSR-44715-16 Dated: 01.12.2015 19._| MIRTAZAPINE USP DCDIMFG/SR-44/15-16 Dated: 01.12.2015 20. | CHLOROTHYMOL DCDIMFG/SR-44715-16 Dated: 01.12.201521. | MISOPROSTOL IP DCD/MFGISR-44/15-16 Dated: 01.12.2015 22. | MISOPROSTOL USP DCD/MFGISR-44/15-16 Dated: 01.12.2015 23. | MISOPROSTOL HPMC DISPERSION 1% wiw DCD/MFGISR-44/15-16 CONTAINING MISOPROSTOL IP 1% w/w Dated: 01.12.2015 24, | MISOPROSTOL HPMC DISPERSION 1% w/w DCD/MFG/SR-44/15-16 _ CONTAINING MISOPROSTOL USP 1% wiw Dated: 01.12.2015 35, DCD/MFG/SR-44/15-16 | TRIHEXYPHENIDYL HYDROCHLORIDE IP Dated: 01.12.2015 26. DCD/MFGSR-44/15-16 ‘TRIHEXYPHENIDYL HYDROCHLORIDE BP paeE O1ts 2018 7 fl DCD/MFGISR-44/15-16 | ‘TRIHEXYPHENIDYL HYDROCHLORIDE USP Dae OI ants a 28. | | DCDIMFGISR-44/15-16 ‘TRIHEXYPHENIDYL HYDROCHLORIDE Ph.Eur | Dated: 01.12.2015 29. : DCDMFGISR-44/15-16 | | SEVELAMER CARBONATE paseo 3018 30. DCD/MFGISR-44/15-16 SEVELAMER HYDROCHLORIDE Dated: 01.12.2015 31, | ARIPIPRAZOLE USP DCDIMFG/CR-244/16-17 | Dated -24/10/2016 DCD/MFGICR-344/18-19 Dated-14/12/2018 | 32. ONDANSETRON IP DCD/MFGICR-724/18-19 | | Dated-06/03/2019 33. | PALIPERIDONE USP DCD/MFGICR-725/18- 19;Dated-08/04/2019 34. | PALIPERIDONE IP DCD/MFGICR-725/18- _ | 19;Dated-08/04/2019 35. | LOPERAMIDE HYDROCHLORIDE IP DCD/MFG/SR-44/15-16; Dated- 01/12/2015 36. | DIMETINDENE MALEATE. BP DCD/MFGICR-| 142/17-18; Dated-13/06/2018, a7 DCD/MFGICR-987/17- 18;Dated-05/06/2018 DCD/MFGICR-343/18-19; Dated-14/12/2018 38. DCD/MFGICR-987/17- 18;Dated-05/06/2018 RISPERIDONE BE: DCD/MFGICR-343/18-19; Dated-14/12/2018 39, DCD/MFGICR-987/17- : 18;Dated-05/06/2018 RISPERIDONE Ph Eur DCD/MFGICR-343/18-19; Dated-14/12/2018 40. DCD/MFG/CR-1043/17-18; Dated-05/06/2018 eee DCD/MFG/CR-345/18-19; Dated-14/122018 RISPERIDONE USPDOMESTIC ONLY a1 ‘COLCHICINE IP DCD/MFGICR-358/18-19; Dated-29/1 1/2018 2. | THIOCOLCHICOSIDE IP DCD/MFGICR-358/18-19; Dated-29/11/2018, EXPORT ONLY 43. | COLCHICINE Ph. Eur DCD/MFGICR-358/18-19;, Dated-29/11/2018 44. | COLCHICINE USP DCD/MFGICR-358/18-19, Dated-29/11/2018 APPROVED FORTY FOUR PRODUCTS ONLY, (AmaréshTumbagi) Additional Drugs Controller & Licensing AuthorityLIST OF APPROVED COMPETENT TECHNICAL STAFFS OF M/S.. ANUGRAHA. CHEMICALS, NO.._D-47. TO. 50. .C-62..& C-63,. KSSIDC, INDUSTRIAL ESTATE, DODDABALLAPUR, BENGALURU — 561 203, UNDER LICENCES IN FORM 25 & 28 BEARING NO’S. KTK/25/549/2008 & KTK/28/417/2014, dated 20.11.2015. FOR THE PERIOD 14.02,2020 TO 13.02.2025 VIDE REF. NO.DCD/MFG/SR-681/19-20. fe Name of the Competent Technical Persons Qualification Manufacturing T__[ Sri. Ethirajulu [ MSe Testing 2, | Smt. Yasmeen Fathima I MSc vonktheane Additional Drugs Controller & Licensing AuthorityGOVERNMENT OF KARNATAKA DRUGS CONTROL DEPARTMENT Office of the Drugs Controller For the State of Kamataka Palace Road,Bangalore-01 No,.DCD/MFG/Application Id-241 Date : 26/06/2020 To, ANUGRAHA CHEMICALS No: 0-47, D-48, D-49, D-50, C-62 & C-63 KSSIDC INDL ESTATE, DODDABALLAPUR,, BENGALURUR, Dist:Bengaluru Rural,561203, India Sir, ‘Sub: Drugs & Cosmetics Act, 1940 and Rules 1945 Retention of licence. Ref: 1. Your application dated 10/02/2020. 2. Challan No, CR0220021000178738, dated 10/02/2020, Rs. 2200.00. With reference to the above, in view of licence retention fee deposited vide challan referred above. The licence in Form 28 granted to you bearing No. KTK/28/0417/2014 , dated 14/02/2015 shall remain valid for the period 14/02/2020 to 13/02/2025. The licence shall remain valid unless it is suspended or cancelled by Licensing Authority. Yours faithfully, AMARESH janes tren TUMBAGI fii; c0n30 Additional Drugs Controller & Licensing Authority Drugs Control Department, Karnataka.LIST OF PRODUCT RETAINED FOR THE PERIOD 14.02.2020 TO. 13.02.2025. TO BE MANUFACTURED BY M/S. ANUGRAHA CHEMICALS, NO. D-47 TO 50, C-62 & C- 63. KSSIDC. INDUSTRIAL ESTATE, DODDABALLAPUR. BENGALURU -— 561.203 UNDER LICENCE IN FORM 28 BEARING NO. KTK/28/417/2014, DATED: 20.11.2015 VIDE REF. NO. DCD/MFG/SR-681/19-20. sl. | No. | 1 BENFOTIAMINE DCD/MFG/SR-44/15-16, Dated: 01.12.2015 Name of the Bulk Drug Product Permission No. and date | APPROVED ONE PRODUCT ONLY (Amaresh Tumbagi) Additional Drugs Controller & Licensing Authority