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

16:36, 17/04/2024

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.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE

74 lượt xem

- The legal regulations in this article are according to Vietnamese Law;
- This English translation is for reference purposes only and not a definitive translation of the original Vietnamese texts;
- Articles may be compiled from a variety of sources;
- Applicable Terms may have expired at the time you are reading;
- If you have any questions about the copyright of the article, please contact us via email banquyen@lawnet.vn

Address:	19 Nguyen Gia Thieu, Vo Thi Sau Ward, District 3, Ho Chi Minh City
Phone:	(028) 7302 2286
E-mail:	info@lawnet.vn