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)
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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 |
Dosage form |
Unit (5) |
Category of technical specifications |
|
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.
- Key word:
- EU-GMP principles
- in Vietnam
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