DRUGS CONTROL ADMINISTRATION O C A Government of Telangana OftUOS CONHIOl AOMINI!llltATIOH

TELAHCAHA

L.Dis.No.6449/E(K)/TS/2017 Dated: Z I

To M/s Hetero Labs Limited Unit-Y, TSIIC Formulation SEZ Sy.No. 439, 440, 441 & 458, Polepally village, Jadcherla Mandai, Mahaboobnagar District.

Sirs, Sub: Drugs and Cosmetics Act, 1940 and Rules made thereunder - Issue of

World Health Organization Good Manufacturing Practice Certificate­Regarding

Ref: 1 Your application dated. 19.04.2017 2 Joint Inspection Report dated. 23.05.2017 & 24.05.2017.

I fotward herewith WORLD HEALTH ORGANISATION GOOD

MANUFACTURING PRACTICE CERTIFICATE for the products recommended by the Joint

Inspection Team consisting of officers of Drugs Control Administration, Telangana State, India

for Export purpose.

This Certificate is valid for a period of Two years from the date of issue. This certificate

is meant for Export of drugs only.

Yours faithfully,

Licensing & Controlling Authority

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUGS CONTROL AOMINIS'Tft"TIOH

TEL"NCANA

L.Dis.No.6449/E(K)/TS/20 17 Dated: - 05- 2017

LIST OF PRODUCTS APPROVED UNDER WHO GMP CERTIFICATION SCHEME FOR EXPORT PURPOSE

1. EF A VIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 600/300/300 mg Each film coated tablet contains: Efavirenz Lamivudine Tenofovir Disoproxil Fumarate Equivalent to Tenofovir Disoproxil

USP USP

600 mg 300mg 300 mg 245 mg

2. Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20mg/12.5mg Each film coated tablet contains: Olmesartan Medoxomil Hydrochlorothiazide

USP USP

20 mg 12.5 mg

3. Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40mg/12.5mg Each film coated tablet contains: Olmesartan Medoxomil Hydrochlorothiazide

USP USP

40mg 12.5 mg

4. Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40mg/25mg Each film coated tablet contains: Olmesartan Medoxomil Hydrochlorothiazide

USP USP

40mg 25 mg

5. Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20mg/12.5mg Each film coated tablet contains: Olmesartan Medoxomil Hydrochlorothiazide

Ph.Eur Ph.Eur

20mg 12.5 mg

6. Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40mg/12.5mg Each film coated tablet contains: Olmesartan Medoxomil Hydrochlorothiazide

Ph.Eur. Ph.Eur.

40mg 12.5 mg

7. Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40mg/25mg Each film coated tablet contains: Olmesartan Medoxomil Hydrochlorothiazide

Ph.Eur. Ph.Eur.

8. ROSUV AST A TIN CALCIUM TABLETS 5 mg Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

40 mg 25 mg

5 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana OfiUG8 CONTROl AOMINIS'Tf!A.TIOH

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9. ROSUV ASTATIN CALCIUM TABLETS I 0 mg Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

10. ROSUV AST A TIN TABLETS 10 mg ROST 10 Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

11. ROSUV ASTATIN CALCIUM TABLETS 20 mg Each film coated tablet contains: Rosuvastatin Calcium. Equivalent to Rosuvastatin

12. ROSUV ASTATIN TABLETS 20 mg ROST20 Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

13. ROSUV ASTATIN CALCIUM TABLETS 40 mg Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

14. PRASUGREL TABLETS 5mg Each Film-Coated tablet contains:

15.

16.

17.

Prasugrel Hydrochloride Equivalent to Prasugrel

PRASUGREL TABLETS 10mg Each Film-Coated tablet contains: Prasugrel hydrochloride Equivalent to Prasugrel

Mycophenolate Mofetil Capsules 250mg Each capsule contains Mycophenolate Mofetil Ph.Eur

Mycophenolate Mofetil Tablets 500mg Each Tablets contains Mycophenolate Mofetil, Ph.Eur

10 mg

10 mg

20mg

20mg

40mg

5 mg

10 mg

250 mg

500 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUGS CONTROl AOHINIS'lfi:"TIOH

TE'LAHCAfoiA

L.Dis.No.6449/E(K)/TS/2017 Grant of WHO GMP Certificate.

18. ABACA VIR TABLETS 300mg Each Film Coated tablet contains Abaca vir 300mg

19. EFA VIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 mg/200 mg/300 mg TRUSTIVA Each film coated tablet contains: Efavirenz USP Emtricitabine USP Tenofovir Disoproxil Fumarate Equivalent to Tenofovir Disoproxil

20. LOSARTAN POTASSIUM TABLETS 50 mg Each film coated tablet contains: Losartan Potassium Ph.Eur

600mg 200mg 300mg 245mg

50mg

21. FEXOFENADINE HYDROCHLORIDE TABLETS 180 mg FEXOGEN 180 Each film coated tablet contains: Fexofenadine Hydrochloride Ph.Eur. 180 mg

22. IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS 150mg/12.5mg IRBIGEN-H 150mg/12.5 mg Each film coated tablet contains: Irbesartan Hydrochlorothiazide

23. ARIPIPRAZOLE TABLETS lOmg DERIPEX 10 Each tablet contains: Aripiprazole

24. ARIPIPRAZOLE TABLETS 15mg DERIPEX 15 Each tablet contains: Aripiprazole

25. TELMISRATAN TABLETS 40mg TELCARD40 Each tablet contains: Telmisartan

Ph.Eur. Ph.Eur.

Ph.Eur.

150mg 12.5 mg

10mg

15mg

40mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana OROGS CONTROl AOMINISTAATION

TElA.NCANA

L.Dis.No.6449/E(K)/TS/20 I7 Grant of WHO GMP Certificate.

26. TELMISRA TAN TABLETS 80mg TELCARD 80 Each tablet contains: Telmisartan Ph.Eur. 80mg

27. OLMESARTAN MEDOXOMIL TABLETS 20mg OLMICARD 20 Each film coated tablet contains: Olmesartan Medoxomil Ph.Eur. 20mg

28. OLMESARTAN MEDOXOMIL TABLETS 40mg OLMICARD40 Each film coated tablet contains: Olmesartan Medoxomil Ph.Eur. 40mg

29. V ALGANCICLOVIR TABLETS 450 mg GANCIL450 Each Film- Coated tablet contains: Valganciclovir Hydrochloride 496.3 mg Equivalent to Valganciclovir 450 mg

30. OLANZAPINETABLETS5mg OLANZASmg Each film coated tablet contains: Olanzapine Ph.Eur 5 mg

31. OLANZAPINE TABLETS I Omg OLANZA 10 mg Each film coated tablet contains: Olanzapine Ph.Eur IO mg

32. MONTELUKAST SODIUM TABLETS I Omg MONTIKARlO Each film coated tablet contains: Montelukast Sodium Ph.Eur. Equivalent to Montelukast IO mg

33. LEVOFLOXACIN TABLETS 250mg LIVA 250 Each film coated tablet contains: Levofloxacin Hemihydrate 256.24 mg Equivalent to Levofloxacin 250mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUGS CONTROl AOMINISTRATIOH

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34. LEVOFLOXACIN TABLETS 500mg LIVA 500 Each film coated tablet contains: Levofloxacin Hemihydrate Equivalent to Levofloxacin

35. CLOPIDOGREL TABLETS 75mg THINRIN 75 Each film coated tablet contains: Clopidogrel Hydrogen Sulfate Equivalent to Clopidogrel

36. AMLODIPINE TABLETS lOmg ACT 10 Each uncoated tablet contains: Am1odipine Besilate Equivalent to Amlodipine

Ph.Eur.

Ph.Eur

512.47 mg 500mg

75mg

13.868 mg lOmg

37. PANTOPRAZOLE GASTRO RESISTANT TABLETS 20mg PAN20 Each gastro resistant tablet contains: Pantoprazole Sodium Sesquihydrate Ph.Eur. Equivalent to Pantoprazole 20mg

38. PANTOPRAZOLE GASTRO RESISTANT TABLETS 40mg PAN40 Each gastro resistant tablet contains: Pantoprazole Sodium Sesquihydrate Ph.Eur. Equivalent to Pantoprazole 40mg

39. AMLODIPINE TABLETS 5 mg CARZODINE 5 Each uncoated tablet contains: Amlodpine Besilate Equivalent to Amlodipine

40. AMLODIPINE TABLETS lOmg CARZODINE 10 Amlodpine Besilate Ph. Eur. Equivalent to Amlodpine

4 1. IRBESARTAN TABLETS 150 mg WINSART AN 150 Each film coated tablet contains: lrbesartan

Ph.Eur.

Ph.Eur

6.934 mg 5mg

13.869 mg 10 mg

150mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUGS CONTROl AOHINISTRA.TIOH

TElAHCAHA

L.Dis.No.6449/E(K)!TS/20 17 Grant of WHO GMP Certificate.

42.

43.

44.

45.

46.

47.

48.

49.

IRBESARTAN TABLETS 300 mg WINSARTAN 300 Each film coated tablet contains: Irbesartan Ph.Eur

Clopidogrel Tablets 75 mg CLOVAX75 Each film coated tablet contains: Clopidogrel Hydrogen Sulfate Ph.Eur Equivalent to Clopidogrel

SILDENAFIL CITRATE TABLETS 25 mg HETAGRA-25 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

SILDENAFIL CITRATE TABLETS 50 mg HETAGRA-50 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

SILDENAFIL CITRATE TABLETS 100 mg HETAGRA-100 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

SILDENAFIL CITRATE TABLETS 25 mg SILDENAFILORIFARM 25 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

SILDENAFIL CITRATE TABLETS 50 mg SILDENAFILORIFARM 50 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

SILDENAFIL CITRATE TABLETS 100 mg SILDENAFILORIFARM 100 Each film coated tablet contains: Sildenafil Citrate Equivalent to Sildenafil

Ph.Eur.

300mg

75mg

25mg

50 mg

100 mg

35.12 mg 25 mg

70.24mg 50mg

140.48mg 100 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana OfiUGS COHTfiOl AOMINISTffA.TIOH

TELAHCANA

L.Dis.No.6449/E(K)/TS/2017 Grant of WHO GMP Certificate.

50. SILDENAFIL CITRATE TABLETS 25 mg SILDENOV A 25 mg Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

51. SILDENAFIL CITRATE TABLETS 50 mg SILDENOV A 50 mg Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

52. SILDENAFIL CITRATE TABLETS 100 mg SILDENOV A 100 mg Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

53. SILDENAFIL CITRATE TABLETS 25 mg SIFE 25 mg Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

54. SILDENAFIL CITRATE TABLETS 50 mg SIFE 50 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

55. SILDENAFIL CITRATE TABLETS 100 mg SIFE 100 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

56. SILDENAFIL CITRATE TABLETS 25 mg GIAGRA 25 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

35.12 mg 25 mg

70.24mg 50mg

140.48mg 100 mg

35.12 mg 25 mg

70.24mg 50mg

140.48mg 100 mg

35.1 2 mg 25 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUGS CONTfiOl AOHINISTAAT10f4

TEL~HCANA

L.Dis.No.6449/E{K)/TS/2017 Grant of WHO GMP Certificate.

57. SILDENAFIL CITRATE TABLETS 50 mg GIAGRASO Each film coated tablet contains: Sildenafil Citrate Equivalent to Sildenafil

Ph.Eur.

58. SILDENAFIL CITRATE TABLETS 100 mg GIAGRA 100 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

59. SILDENAFIL CITRATE TABLETS 25 mg CAMASTIL25 Each film coated tablet contains: Sildenafil Citrate Equivalent to Sildenafil

Ph.Eur.

60. SILDENAFIL CITRATE TABLETS 50 mg CAMASTILSO Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

6 1. SILDENAFIL CITRATE TABLETS 100 mg CAMASTIL 100 Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

70.24mg 50mg

140.48mg 100 mg

35.12 mg 25 mg

70.24mg 50mg

140.48mg 100 mg

62. ABACA VIR AND LAMIVUDINE TABLETS 600/300 mg Each film coated tablet contains: Abaca vir Lamivudine Ph.Eur.

600mg 300mg

63. LAMIVUDINE AND ZIDOVUDINE TABLETS USP 150/300 mg LAVUZID Each film coated tablet contains Lamivudine Zidovudine

USP USP

64. Lamivudine and Zidovudine Tablets 150/300 mg LAZID 150/300 mg Each film coated tablet contains: Lamivudine Zidovudine

Ph.Eur. Ph. Eur.

150mg 300 mg

150mg 300mg

DCA DRUGS CONTROL ADMINISTRATION

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TELANCANA

L.Dis.No.6449/ECK)/TS/20 17 Grant of WHO GMP Certificate.

65. ABACA VIR SULFATE & LAMIVUDINE TABLETS 600mg/300 mg ABCAR-L 600/300 Each film coated tablet contains: Abacavir Sulfate USP Equivalent to Abacavir Lamivudine

66. ARIPIPRAZOLE TABLETS 10 mg ARIPIFY 10 Each tablet contains: Aripiprazole

67. OLANZAPINE TABLETS 10 mg ZYPIN 10 Each film coated tablet contains: Olanzapine

USP

Ph.Eur

68. ESCITALOPRAM TABLETS 10 mg ESILEX 10

69.

Each film coated tablets contains: Escitalopram Oxalate Equivalent to Escita1opram

CELECOXJB CAPSULES 200 mg Each capsule contains: Celecoxib Ph.Eur

70. CELECOXJB CAPSULES 200 mg SIBREX200 Each capsule contains: Celecoxib Ph.Eur

600mg 300mg

10mg

10mg

lOmg

200mg

200mg

71. ABACA VIR SULFATE & LAMIVUDINE TABLETS 600/300 mg ABALAM Each film coated tablet contains: Abacavir Sulfate Equivalent to Abacavir Lamivudine

USP

USP 600mg 300mg

72. MYCOPHENOLATE MOFETIL CAPSULES USP 250 mg Each capsule contains Mycophenolate Mofetil USP 250 mg

73. MYCOPHENOLATE MOFETIL TABLETS USP 500 mg Each tablet contains Mycophenolate Mofetil USP 500 mg

DCA DRUGS CONTROL ADMINISTRATION

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74. ROS UV ASTATIN CALCIUM TABLETS 5 mg Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

75. ROSUVASTATIN CALCIUM TABLETS 10 mg Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

76. ROSUVASTATIN CALCIUM TABLETS 20 mg Each film coated tablet contains: Rosuvastatin Calcium Equivalent to Rosuvastatin

77. ROSUVASTATIN CALCIUM TABLETS 40 mg Each film coated tablet contains:

78.

Rosuvastatin Calcium Equivalent to Rosuvastatin

EPROSARTAN TABLETS 400 mg Each film coated tablet contains: Eprosartan Mesylate Equivalent to Eprosartan

79. EPROSARTAN TABLETS 600 mg Each film coated tablet contains: Eprosartan Mesylate Equivalent to Eprosartan

80. QUETIAPINE FUMARATE TABLETS 25 mg Each film coated tablet contains: Quetiapine Fumarate Equivalent to Quetiapine

81. QUETIAPINE FUMARATE TABLETS 100 mg Each film coated tablet contains: Quetiapine Fumarate Equivalent to Quetiapine

82. QUETIAPINE FUMARATE TABLETS 200 mg Each film coated tablet contains: Quetiapine Fumarate Equivalent to Quetiapine

5mg

10 mg

20mg

40mg

400mg

600mg

28.78 mg 25 mg

11 5. 12mg 100 mg

230.24 mg 200 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUGS CONfiii.Ol AOMINIIT!tATIOH

TELAH QANA

L.Dis.No.6449/E(K)/TS/2017 Grant of WHO GMP Certificate.

83. QUETIAPINE FUMARATE TABLETS 300 mg Each film coated tablet contains: Quetiapine Fumarate Equivalent to Quetiapine

84. OLANZAPINE TABLETS 5 mg Each film coated tablet contains Olanzapine Ph.Eur.

85. OLANZAPINE TABLETS 7.5 mg Each film coated tablet contains Olanzapine Ph.Eur.

86. OLANZAPINE TABLETS 15 mg Each film coated tablet contains Olanzapine Ph .Eur.

345.36 mg 300mg

5 mg

7.5 mg

15 mg

87. FEXOFENADINE HYDROCHLORIDE TABLETS 180 mg Each film coated tablet contains: Fexofenadine Hydrochloride Ph.Eur. 180 mg

88. SILDENAFIL CITRATE TABLETS 25 mg Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

89. SILDENAFIL CITRATE TABLETS 50 mg Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

90. SILDENAFIL CITRATE TABLETS 100 mg Each film coated tablet contains: Sildenafil Citrate Ph.Eur. Equivalent to Sildenafil

91. SILDENAFIL CITRATE TABLETS 20 mg Each film coated tablet contains

92.

Sildenafil Citrate Equivalent to Sildenafil

CLOPIDOGREL TABLETS 75mg Each film coated tablet contains: Clopidogrel Hydrogen Sulfate Ph.Eur. Equivalent to Clopidogrel

35.12 mg 25 mg

70.24 mg 50mg

140.48 mg 100 mg

20mg

75mg

DCA DRUGS CONTROL ADMINISTRATION

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93. RABEPRAZOLE SODIUM DELAYED RELEASE TABLETS 10 mg Each Delayed Release tablet contains Rabeprazole Sodium 10 mg

94. RABEPRAZOLE SODIUM DELAYED RELEASE TABLETS 20 mg Each Delayed Release tablet contains Rabeprazole Sodium 20 mg

95. ENTECA vm. TABLETS 0.5 mg Each film coated tablet contains Entecavir (as monohydrate)

96. ENTECA vm. TABLETS 1 mg Each film coated tablet contains

Entecavir (as monohydrate)

97 OLMESARTAN MEDOXOMIL TABLETS 5 mg Each Film- Coated tablet contains: Olmesartan Medoxomil USP

98 OLMESARTAN MEDOXOMIL TABLETS 20 mg Each Film- Coated tablet contains: Olmesartan Medoxomil USP

99. OLMESART AN MEDOXOMIL TABLETS 40 mg Each Film - Coated tablet contains: Olmesartan Medoxomil USP

100. CELECOXIB CAPSULES 100 mg Each capsule contains: Celecoxib Ph.Eur.

101. PERINDOPRIL TABLETS 8 mg Each tablet contains: Perindopril tert-Butylamine Ph.Eur Equivalent to Perindopril

0.5 mg

1 mg

5mg

20mg

40mg

100 mg

8 mg 6.676 mg

102. VALACYCLOVIR HYDROCHLORIDE TABLETS USP 500 mg Each film coated tablet contains: Valacyclovir Hydrochloride Equivalent to Valacyclovir

USP 556 mg 500 mg

103. VALACYCLOVIR HYDROCHLORIDE TABLETS USP 1000 mg Each film coated tablet contains Valacyclovir Hydrochloride USP 1112 mg Equivalent to Valacyclovir 1 000 mg

•

DCA DRUGS CONTROL ADMINISTRATION

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L.Dis.No.6449/ECK)/TS/20I7 Grant of WHO GMP Certificate.

104. EFA VIRENZ TABLETS USP 600 mg Each film coated tablet contains Efavirenz USP 600 mg

105. DONEPEZIL HYDROCHLORIDE TABLETS USP 5 mg Each film coated tablet contains: Donepezil Hydrochloride USP 5 mg

106. DONEPEZIL HYDROCHLORIDE TABLETS USP 10 mg Each film coated tablet contains: Donepezil Hydrochloride USP IO mg

I07. Entecavir Tablets 0.5 mg TECAVIR0.5 Each film coated tablet contains: Entecavir 0.5 mg

I08. Entecavir Tablets I mg TECAVIR 1 Each film coated tablet contains: Entecavir I mg

109. ABALAM (Abacavir Sulfate & Lamivudine Tablets 600mg/300 mg) Each film coated tablet contains: Abacavir Sulfate USP Equivalent to Abacavir 600mg Lamivudine USP 300mg

I10. MONTELUKAST SODIUM PAEDIATRIC CHEWABLE TABLETS 4 mg WINMON Each tablet contains: Montelukast Sodium Equivalent to Montelukast

Ph.Eur 4mg

1II. MONTELUKAST SODIUM PAEDIATRIC CHEW ABLE TABLETS 5 MG WINMON Each Chewable tablet contains: Montelukast Sodium Equivalent to Montelukast

Ph.Eur

Il 2. MONTELUKAST SODIUM TABLETS I Omg WINMON Each film coated tablets contains Montelukast sod ium Equivalent to Montelukast

Ph.Eur

5mg

IOmg

DCA DRUGS · CONTROL ADMINISTRATION

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113. ENTECAVIR TABLETS 0.5 mg BENVIR Film Coated tablets 0.5mg Each film coated tablet contains: Entecavir 0.5mg

114. ENTECA VIR TABLETS 1 mg BENVIR Film Coated tablets lmg Each film coated tablet contains: Entecavir lmg

115. VALGANCICLOVIR TABLETS 450 mg XANVOR Film coated tablets 450 mg Each film coated tablet contains: Valganciclovir Hydrochloride USP 496.3mg Equivalent to Valganciclovir 450mg

116. ABACA VIR SULFATE & LAMIVUDINE TABLETS 600 mg/300 mg ABCAR-L 600/300 Each film coated tablet contains: Abacavir Sulfate USP Equivalent to Abacavir 600mg Lamivudine USP 300mg

117. OLANZAPINE TABLETS 2.5 mg OLANTERO 2.5 mg Each film coated tablet contains: Olanzapine Ph.Eur. 2.5mg

118. OLANZAPINE TABLETS 5 mg OLANTERO 5 mg Each film coated tablet contains: Olanzapine Ph.Eur. 5mg

119. OLANZAPINE TABLETS 10 mg OLANTERO 10 Each film coated tablet contains: Olanzapine Ph.Eur. 10mg

120. OLANZAPINE TABLETS 15 mg OLANTERO 15 mg Each film coated tablet contains: Olanzapine Ph.Eur. 15mg

DCA DRUGS CONTROL ADMINISTRATION

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121. Donepezil Hydrochloride Tablets 5 mg DEMIZEPT5 Each film coated tablet contains Donepezil Hydrochloride USP 5mg

122. Donepezil Hydrochloride Tablets 10 mg DEMIZEPT 10 Each film coated tablet contains Donepezil Hydrochloride USP 10 mg

123. Escitalopram tablets 10 mg ALVODEP10 Each film coated tablet contains: Escitalopram Oxalate Equivalent to Escitalopram 10 mg

124. Escitalopram tablets 20 mg ALVODEP 20 Each film coated tablet contains: Escitalopram Oxalate Equivalent to Escitalopram 20mg

125. Aripiprazole Tablets10 mg ALVOPIP 10 Each tablet contains Aripiprazole 10mg

126. Aripiprazole Tablets 15 mg ALVOPIP 15 Each tablet contains Aripiprazole 15 mg

127. Alfuzosin Hydrochloride Extended Release Tablets 10 mg UROZEEN 10 Each tablet contains: Alfuzosin Hydrochloride Ph.Eur. 10 mg

128. Levofloxacin Tablets 500 mg CIDIQUIN 500 Each film coated tablet contains: Levofloxacin Hemihydrate 512.47 mg Equivalent to Levofloxacin 500 mg

DRUGS CONTROL ADMINISTRATION

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1£LANCANA

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129. SILDENAFIL CITRATE TABLETS 50 mg FREEXASO Each film coated tablet contains: Sildenafil Citrate Ph.Eur. 70.24 mg Equivalent to Sildenafil 50mg

130. SILDENAFIL CITRATE TABLETS 100 mg FREEXA 100 Each film coated tablet contains: Sildenafil citrate Ph.Eur. 140.48 mg Eq. to Sildenafil 100mg

131. LAMIVUDINE TABLETS 100 mg Each film coated tablet contains: Lamivudine Ph.Eur 100 mg

132. V ALSART AN TABLETS 320 mg Each film coated tablet contains: Valsartan Ph.Eur 320mg

133. Valsartan Tablets 320 mg VALSAR320 Each film coated tablet contains: Valsartan Ph.Eur 320mg

134. Valsartan Tablets 320 mg VALSARH320 Each film coated tablet contains: Valsartan Ph.Eur 320mg

135. Valsartan Tablets 320 mg V ALTER0-320

Each film coated tablet contains: Valsartan Ph.Eur 320mg

136. Valsartan Tablets 320 mg VALSART320 Each film coated tablet contains: Valsartan Ph.Eur 320 mg

137. PANTOPRAZOLE SODIUM DELAYED RELASE TABLETS USP 20 mg PANTIN 20 Each delayed release tablet contains: Pantoprazole sodium Sesquihydrate USP Equivalent to Pantoprazole 20mg

DCA DRUGS CONTROL ADMINISTRATION

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138. PANTOPRAZOLE SODIUM DELAYED RELASE TABLETS USP 40 mg PANTIN 40 Each delayed release tablet contain: Pantoprazole sodium Sesquihydrate USP Equivalent to Pantoprazole

139. QUETIAPINE FUMARATE TABLETS I 50 mg QUTERO 150 Each film coated tablet contains Quetiapine Fumarate Equivalent to Quetiapine

140. LINEZOLID TABLETS 600 mg LINEZOLE 600 mg Each film coated tablet contains: Linezolid

141. ROSUVASTATINTABLETS 5mg CAROZAS Each film coated tablet contains: Rosuvastatin (As Rosuvastatin Calcium)

142. ROSUV ASTATIN TABLETS lOmg CAROZAIO Each film coated tablet contains: Rosuvastatin (As Rosuvastatin Calcium)

143. ROSUV ASTATIN TABLETS 20 mg CAROZA20 Each film coated tablet contains: Rosuvastatin (As Rosuvastatin Calcium)

144. ROSUV AST ATIN TABLETS 40 mg CAROZA40 Each film coated tablet contains: Rosu vasta tin (As Rosuvastatin Calcium)

145. LACOSAMIDE TABLETS 50 mg LACOX50 Each film coated tablet contains: Lacosamide

40mg

172.68 mg 150 mg

600mg

5mg

lOmg

20mg

40mg

50mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana Ofl;UGS CONTilDl. ADMINISTfM.TIOH

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L.Dis.No.6449/E(K)/TS/2017 Grant of WHO GMP Certificate.

146. LACOSAMIDE TABLETS 100mg LACOX 100 Each film coated tablet contains: Lacosamide

147. LACOSAMIDE TABLETS 150mg LACOX 150 · Each film coated tablet contains: Lacosamide

148. LACOSAMIDE TABLETS 200mg LACOX200 · Each film coated tablet contains: Lacosamide

100 mg

150mg

200mg

149. PIOGLITAZONE HYDROCHLORIDE TABLETS 15 mg Each tablet contains: Pioglitazone Hydrochloride Equivalent to Pioglitazone 15 mg

150. PIOGLITAZONE HYDROCHLORIDE TABLETS 30 mg Each tablet contains: Pioglitazone Hydrochloride Equivalent to Pioglitazone 30 mg

151. PIOGLITAZONE HYDROCHLORIDE TABLETS 45 mg Each tablet contains: Pioglitazone Hydrochloride Equivalent to Pioglitazone 45 mg

152. ACYCLOVIR TABLETS USP 400 mg Each tablet contains: Acyclovir USP

153. ACYCLOVIR TABLETS USP 800 mg Each tablet contains: Acyclovir

154. CELECOXIB CAPSULES 100 mg Each capsule contains: Celecoxib

155. CELECOXIB CAPSULES 200 mg Each capsule contains: Celecoxib

USP

400 mg

800 mg

100 mg

200 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUG$ CONTROl AOMINISTRAT101'4

TE:LAHCANA

L.Dis.No.6449/E(K)/TS/2017 Grant ofWHO GMP Certificate.

156. PERINDOPRIL ERBUMINE TABLETS 8 mg Each tablet contains: Perindopril Erbumine 8 mg

157. DONEPEZIL HYDROCHLORIDE TABLETS 5 mg Each film coated tablet contains: Donepezil Hydrochloride USP 5 mg

158. DONEPEZIL HYDROCHLORIDE TABLETS 10 mg Each film coated tablet contains: Donepezil 10 mg

159. Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumarate Tablets 600mg/ 200 mg/ 300 mg Each film coated tablet contains: Efavirenz Emtricitabine Tenofovir Disoproxil fumarate Equivalent to Tenofovir Disoproxil

USP 600 mg 200 mg 300 mg 245 mg

160. Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumarate Tablets 600mg/ 200 mg/ 300 mg TRUSTIVA Each film coated tablet contains: Efavirenz Emtricitabine Tenofovir Disoproxil fumarate Equivalent to Tenofovir Disoproxil

161. Levofloxacin Tablets 250 mg LEVIN250 Each film coated tablet contains Levofloxacin Hemihydrate Equivalent to Levofloxacin

162. Levofloxacin Tablets 500 mg LEVIN 500 Each film coated tablet contains Levofloxacin Hemihydrate Equivalent to Levofloxacin

163. Sildenafil Citrate Tablets 25 mg SIFE 25 Each film coa ted tablet contains Sildenafil citrate Equivalent to Sildenafil

USP USP

600mg 200 mg 300 mg 245 mg

256.24 mg 250 mg

512.47 mg 500 mg

25 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana ORUGS CONTR Ol AOMINIS1RA.TIOH

TELA.HGANA

L.Dis.No.6449/E(K)/TS/2017 Grant of WHO GMP Certificate.

164. Sildenafil Citrate Tablets 50 mg SIFE 50 Each film coated tablet contains Sildenafil citrate Equivalent to Sildenafil

165. Sildenafil Citrate Tablets 100 mg SIFE 100 Each film coated tablet contains Sildenafil citrate Equivalent to Sildenafil

166. Famciclovir Tablets 125 mg PENVIR 125 Each film coated tablet contains Famciclovir

167. Famciclovir Tablets 250 mg PENVIR250 Each film coated tablet contains Famciclovir

168. Famciclovir Tablets 500 mg PENVIRSOO Each film coated tablet contains Famciclovir

169. Famciclovir Tablets 750 mg PENVIR 750 Each film coated tablet contains Famciclovir

170. Montelukast Sodium Paediatric Chewable Tablets 4 mg MONTE-H4 Each tablet contains Montelukast Sodium Equivalent to Montelukast

171. Montelukast Sodium Paediatric Chewable Tablets 5 mg MONTE-HS Each tablet contains Montelukast Sodium Equivalent to Montelukast

50 mg

100 mg

125 mg

250mg

500 mg

750 mg

4 mg

5 mg

DCA DRUGS CONTROL ADMINISTRATION

Government of Telangana DRUGS CONTitOL AOMIHIIlRATIOH

T£L ... H CA HA

L.Dis.No.6449/E(K)/TS/2017 Grant of WHO GMP Certificate.

172. Montelukast Sodium Tablets 10 mg MONTE-H 10 Each film coated tablet contains Montelukast Sodium Equivalent to Montelukast I 0 mg

173. Zidovudine, Lamivudine and Nevirapine Tablets 300mg/150mg/200mg ZIDOLAM-N Each film coated tablet contains: Zidovudine Lamivudine Nevirapine

Manufacturer

When applicable

USP USP USP

300 mg 150 mg 200mg

M/s. Hetero Labs Limited Unit-V, TSIIC Formulation SEZ, Sy.No. 439, 440, 441 & 458, Polepally village, Jadcherla Mandai, Mahaboobnagar District, Telangana.

Placing the product on the market as Detailed above.

It is certified that these products has been authorized to be placed on the market for use in the country and exporting countries.

Drug License No. 50/MN/AP/2009/F/R dt. 19-12-2009 in Form- 25.

The firm M/s. Hetero Labs Limited, Unit-Y, Sy.No.439, 440, 441 & 458, TSIIC formulation SEZ, Polepally village, Jadcherla Mandai, Mahaboobnagar District, Telangana State, India was jointly inspected by Mr. P. Santhosh, Drugs Inspector Drugs Control Administration, Hyderabad, Telangana, on 23.05.2017 & 24.05.2017.

The manufacturer conforms to requirement for Good Manufacturing Practices in the manufacturing and quality control (As recommended by the World Health Organization) in respect of the products mentioned above (One hundred seventy three) for Export in the international market.

This Certificate is valid for a period of Two years from the date of issue.

Licensing & Controlling Authority

To