List of 08 drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204

List of 08 drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204 (Internet image)

List of drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204

Promulgated together with Decision 590/QD-QLD on August 12, 2024, is the list of 08 drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204. To be specific:

** List of 04 domestically produced drugs and medicinal materials granted 5-year marketing authorization (Appendix I attached to Decision 590/QD-QLD)

1. Registration Entity: Agimexpharm Pharmaceutical Joint Stock Company (Address: 27 Nguyen Thai Hoc, My Binh Ward, Long Xuyen City, An Giang Province, Vietnam)

1.1. Manufacturing Entity: Agimexpharm Pharmaceutical Joint Stock Company - Pharmaceutical Manufacturing Factory Agimexpharm (Address: Lot C4 Binh Hoa Industrial Park, Binh Hoa Commune, Chau Thanh District, An Giang Province, Vietnam)

2. Registration Entity: An Thien Pharmaceutical Joint Stock Company (Address: 314 Bong Sao, Ward 5, District 8, Ho Chi Minh City, Vietnam)

2.1. Manufacturing Entity: An Thien Pharmaceutical Joint Stock Company (Address: Lot C16, Street No. 9, Hiep Phuoc Industrial Park, Hiep Phuoc Commune, Nha Be District, Ho Chi Minh City, Vietnam)

3. Registration Entity: Traphacosapa One Member Ltd. (Address: Group 2, Phan Si Pang Ward, Sapa district-level town, Lao Cai Province, Vietnam)

3.1. Manufacturing Entity: Traphacosapa One Member Ltd. (Address: Lot F5, Dong Pho Moi Industrial Park, Pho Moi Ward, Lao Cai City, Vietnam)

Note:

How to write the quality standard of the medicine in column (6):

- Manufacturer (NSX), Manufacturer's Standard (TCNSX), Internal Standard (TCCS), In-house have equivalent meanings, which are quality standards of medicines established by the manufacturer and can all be written on the medicine label.

- Abbreviations for standard pharmacopoeias: Vietnamese Pharmacopoeia (DDVN), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), Japanese Pharmacopoeia (JP), Chinese Pharmacopoeia (CP), European Pharmacopoeia (EP), International Pharmacopoeia (IP)…

** List of 04 foreign medicines granted 5-year marketing authorization (Appendix II attached to Decision 590/QD-QLD)

1. Registration Entity: Duy Tan Pharmaceutical Joint Stock Company (Address: 38/6i Nguyen Van Troi, Ward 15, Phu Nhuan District, Ho Chi Minh City, Vietnam)

1.1. Manufacturing Entity: Dr. Willmar Schwabe GmbH & Co. KG (Address: Willmar-Schwabe-Str. 4, 76227 Karlsruhe, Germany)

2. Registration Entity: DO HA Pharmaceutical Co., Ltd (Address: No. 30 Tran Phu Collective, Alley 105, Nguyen Phong Sac Street, Group 16, Dich Vong Hau Ward, Cau Giay District, Hanoi, Vietnam)

2.1. Manufacturing Entity: S.C. Slavia Pharm S.R.L. (Address: B-dul Theodor Pallady nr. 44C, sector 3, cod 032266, Bucuresti, Romania)

3. Registration Entity: Pharmaceutical Works POLPHARMA S.A. (Address: ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland)

3.1. Manufacturing Entity: Pharmaceutical Works POLPHARMA S.A.; Medana Branch in Sieradz (Address: 57 Polskiej Organizacji Wojskowej St, 98-200 Sieradz, Poland)

Production Lot Facility: Pharmaceutical Works POLPHARMA S.A.; Medana Branch in Sieradz (Address: 10 Wladyslawa Lokietka St., 98-200 Sieradz, Poland)

Note:

1. How to write the quality standard of the medicine in column (6):

- Manufacturer (NSX), Manufacturer's Standard (TCNSX), Internal Standard (TCCS), In-house have equivalent meanings, which are quality standards of medicines established by the manufacturer and can all be written on the medicine label.

More details can be found in Decision 590/QD-QLD which comes into force in Vietnam from August 12, 2024.

Tran Huyen Trang

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