DRUGS CONTROL ADMINISTRATION OC 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 & 45 8, Polepally village, Jadcherla Mandai, Mahaboobnagar District. Sirs, Sub: Drugs and Cosmetics Act, 1940 and Rules made thereunder - Issue of World Health Organization Good Manuf acturing Practice Certificate- Regarding 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, Licens i ng & Contro lli ng Au thority
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O C A DRUGS CONTROL ADMINISTRATION Government of Telangana · 2021. 1. 25. · Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20mg/12.5mg Each film coated tablet contains: Olmesartan
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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
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
TELA.HCANA
L.Dis.No.6449/E(K)/TS/20 17 Grant of WHO GMP Certificate.
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
T£lAHCANA
L.Dis.No.6449/E(K)!TS/20 17 Grant of WHO GMP Certificate.
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
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.