List of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP principles in Vietnam

Is it true that the Minister of Health has just issued the List of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP principles in Vietnam? - Thuy Duyen (Nghe An)

List of drugs manufactured by at least 03 domestic drug companies in processes that meet eu-gmp principles in Vietnam

List of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP principles in Vietnam (Internet image)

Regarding this matter, LawNet would like to answer as follows:

On April 16, 2024, the Minister of Health issued Circular 03/2024/TT-BYT on a list of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP principles and standards or equivalents and technical specifications in accordance with regulations of the Ministry of Health concerning quality, price, availability.

List of drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP principles in Vietnam

Issued together with Circular 03/2024/TT-BYT is the list of 93 drugs manufactured by at least 03 domestic drug companies in processes that meet EU-GMP principles and standards or equivalents and technical specifications in accordance with regulations of the ministry of health concerning quality, price, availability.

In addition, this list is also published on the website of the Ministry of Health and the website of the Drug Administration of Vietnam.

No

(1)

Name of active ingredient

(2)

Concentration – Content
(3)

Dosage form
(4)

Unit (5)

Category of technical specifications
(6)

1

Acyclovir

400mg

Tablets/capsules

Tablets/capsules

2

2

Acyclovir

800mg

Tablets/capsules

Tablets/capsules

2

3

Albendazole

400mg

Tablets/capsules

Tablets/capsules

2

4

Allopurinol

300mg

Tablets/capsules

Tablets/capsules

2

5

Amisulpride

100mg

Tablets/capsules

Tablets/capsules

2

6

Amisulpride

200mg

Tablets/capsules

Tablets/capsules

2

7

Atenolol

50mg

Tablets/capsules

Tablets/capsules

2

8

Atorvastatin

10mg

Tablets/capsules

Tablets/capsules

2

9

Atorvastatin

20mg

Tablets/capsules

Tablets/capsules

2

10

Bambuterol hydrochloride

10mg

Tablets/capsules

Tablets/capsules

2

11

Betahistine dihydrochloride

16mg

Tablets/capsules

Tablets/capsules

2

12

Bisoprolol fumarate

5mg

Tablets/capsules

Tablets/capsules

2

13

Bisoprolol fumarate

2,5mg

Tablets/capsules

Tablets/capsules

2

14

Bisoprolol fumarate

10mg

Tablets/capsules

Tablets/capsules

2

15

Carvedilol

12,5mg

Tablets/capsules

Tablets/capsules

2

16

Cefazolin

1g

Injectables

Vials

2

17

Cefepime

1g

Injectables

Vials

2

18

Cefepime

2g

Injectables

Vials

2

19

Cefoperazone

1g

Injectables

Vials

2

20

Cefoperazone

2g

Injectables

Vials

2

21

Cefoperazone; Sulbactam

500mg; 500mg

Injectables

Vials

2

22

Cefoperazone; Sulbactam

1g; 500mg

Injectables

Vials

2

23

Cefoperazone; Sulbactam

1g; 1g

Injectables

Vials

2

24

Cefotaxime

1g

Injectables

Vials

2

25

Cefotaxime

2g

Injectables

Vials

2

26

Cefotiam

1g

Injectables

Vials

2

27

Ceftazidime

1g

Injectables

Vials

2

28

Ceftazidime

2g

Injectables

Vials

2

29

Ceftazidime

500mg

Injectables

Vials

2

30

Ceftizoxime

1g

Injectables

Vials

2

31

Ceftriaxone

1g

Injectables

Vials

2

32

Cefuroxime

750mg

Injectables

Vials

2

33

Cefuroxime

1,5g

Injectables

Vials

2

34

Cetirizin dihydrochloride

10mg

Tablets/capsules

Tablets/capsules

2

35

Ciprofloxacin

500mg

Tablets/capsules

Tablets/capsules

2

36

Clopidogrel

75mg

Tablets/capsules

Tablets/capsules

2

37

Colchicine

1mg

Tablets/capsules

Tablets/capsules

2

38

Diosmin; Hesperidin

450mg; 50mg

Tablets/capsules

Tablets/capsules

2

39

Domperidone

10mg

Tablets/capsules

Tablets/capsules

2

40

Eperisone hydrochloride

50mg

Tablets/capsules

Tablets/capsules

2

41

Esomeprazole

40mg

Enteric-coated tablets/capsules

Tablets/capsules

2

42

Esomeprazole

20mg

Enteric-coated tablets/capsules

Tablets/capsules

2

43

Etoricoxib

90mg

Tablets/capsules

Tablets/capsules

2

44

Etoricoxib

120mg

Tablets/capsules

Tablets/capsules

2

45

Ezetimibe

10mg

Tablets/capsules

Tablets/capsules

2

46

Fexofenadine hydrochloride

120mg

Tablets/capsules

Tablets/capsules

2

47

Fexofenadine hydrochloride

60mg

Tablets/capsules

Tablets/capsules

2

48

Fluconazole

150mg

Capsules

Tablets/capsules

2

49

Gabapentin

300mg

Tablets/capsules

Tablets/capsules

2

50

Galantamine

4mg

Tablets/capsules

Tablets/capsules

2

51

Ibuprofen

400mg

Tablets/capsules

Tablets/capsules

2

52

Ibuprofen; Paracetamol

200mg; 325mg

Tablets/capsules

Tablets/capsules

2

53

Irbesartan

150mg

Tablets/capsules

Tablets/capsules

2

54

Irbesartan

300mg

Tablets/capsules

Tablets/capsules

2

55

Lamivudine

100mg

Tablets/capsules

Tablets/capsules

2

56

Lamotrigine

50mg

Tablets/capsules

Tablets/capsules

2

57

Lansoprazole

30mg

Capsules

Tablets/capsules

2

58

Levetiracetam

500mg

Tablets/capsules

Tablets/capsules

2

59

Levocetirizine dihydrochloride

5mg

Tablets/capsules

Tablets/capsules

2

60

Levofloxacin

500mg

Tablets/capsules

Tablets/capsules

2

61

Levofloxacin

250mg

Tablets/capsules

Tablets/capsules

2

62

Linezolid

600mg

Tablets/capsules

Tablets/capsules

2

63

Magnesi lactate dihydrate; Vitamin B6

470mg; 5mg

Tablets/capsules

Tablets/capsules

2

64

Meloxicam

7,5mg

Tablets/capsules

Tablets/capsules

2

65

Metformin hydrochloride

1000mg

Tablets/capsules

Tablets/capsules

2

66

Mirtazapin

30mg

Tablets/capsules

Tablets/capsules

2

67

Montelukast

10mg

Tablets/capsules

Tablets/capsules

2

68

Montelukast

5mg

Tablets/capsules

Tablets/capsules

2

69

Nabumeton

500mg

Tablets/capsules

Tablets/capsules

2

70

Nebivolol

5mg

Tablets/capsules

Tablets/capsules

2

71

Olanzapin

5mg

Tablets/capsules

Tablets/capsules

2

72

Olanzapin

10mg

Tablets/capsules

Tablets/capsules

2

73

Paracetamol

500mg

Tablets/capsules

Tablets/capsules

2

74

Paracetamol; Tramadol hydrocloride

325mg; 37,5mg

Tablets/capsules

Tablets/capsules

2

75

Pcrindopril tert-butylamine

4mg

Tablets/capsules

Tablets/capsules

2

76

Piracetam

800mg

Tablets/capsules

Tablets/capsules

2

77

Quetiapine

200mg

Tablets/capsules

Tablets/capsules

2

78

Quetiapine

100mg

Tablets/capsules

Tablets/capsules

2

79

Rabeprazole natri

20mg

Enteric-coated tablets/capsules

Tablets/capsules

2

80

Rivaroxaban

15mg

Tablets/capsules

Tablets/capsules

2

81

Rosuvastatin

10mg

Tablets/capsules

Tablets/capsules

2

82

Rosuvastatin

20mg

Tablets/capsules

Tablets/capsules

2

83

Rosuvastatin

5mg

Tablets/capsules

Tablets/capsules

2

84

Spiramycin

3.000.000 IU

Tablets/capsules

Tablets/capsules

2

85

Sulpiride

50mg

Tablets/capsules

Tablets/capsules

2

86

Telmisartan

80mg

Tablets/capsules

Tablets/capsules

2

87

Telmisartan

40mg

Tablets/capsules

Tablets/capsules

2

88

Tenofovir disoproxil fumarate

300mg

Tablets/capsules

Tablets/capsules

2

89

Trimetazidine hydrochloride

20mg

Tablets/capsules

Tablets/capsules

2

90

Trimetazidine hydrochloride

35mg

Controlled-release tablets/capsules

Tablets/capsules

2

91

Valsartan

80mg

Tablets/capsules

Tablets/capsules

2

92

Venlafaxin

75mg

Tablets/capsules

Tablets/capsules

2

93

Vitamin B1; Vitamin B6; Vitamin B12

100mg; 200mg; 200mcg

Tablets/capsules

Tablets/capsules

2

Notes:

1. Regarding names of active ingredients of drugs:

- If the name of a drug is different from the name of the active ingredient (chemical name) in Column (2) and is written in specialized pharmaceutical documents (such as Pharmacopoeia, National Pharmacopoeia and other documents), the drug still belongs to the list (E.g. Paracetamol or Acetaminophen; Acyclovir or Aciclovir; Cefuroxime or Cefuroxim; Sodium or Natri; Hydrochloride or Hydroclorid, etc.).

- If the salt base of an active ingredient in Column (2) is not specified, different salts of this active ingredient, after being converted into bases with the same concentrations and content in Column (3) (with the same indications and dosage) still belong to the list.

2. The bidding for a drug whose dosage form is different from that written in Column (4) shall comply with regulations on drug bidding.

3. “Regarding dosage forms written in Column (4):

- Dosage forms "Tablets/capsules", "Injectables" written in Column 4 are conventional dosage forms (Pills: Tablets, Capsules; Injectables: Solution for injection, Suspension for injection, Emulsion for injection).

- Procuring units and health facilities are permitted to develop their own contractor selection plans in which bidding documents and request for proposals permit bidders to offer imported drugs with special dosage forms or drugs with bioavailability that is different from conventional dosage forms (E.g. Enteric-coated tablets/capsules, Controlled-release tablets/capsules, Fast disintegrating tablets/capsules, Effervescent tablets, Sublingual tablets; Lyophilized injectables, Liposomal/nano/lipid complex injectables, Intraocular injectables, Long-acting injectables, Metered-dose injection applicators, etc.)”.

4. Imported drugs that fall into the Categories in Column (6) must not be offered.

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