Công văn 11575/QLD-ĐK năm 2017 về đính chính danh mục nguyên liệu làm thuốc được phép nhập khẩu không yêu cầu giấy phép nhập khẩu của thuốc trong nước đã được cấp số đăng ký do Cục Quản lý Dược ban hành

Tên thuốc

(1)

SĐK

(2)

Ngày hết hạn SĐK (dd/mm/yy)

(3)

Tên NSX

(4)

Dược chất (ghi đầy đủ tên, dạng nguyên liệu, dạng muối …)

(5)

Tiêu chuẩn dược chất

(6)

Tên NSX nguyên liệu

(7)

Địa chỉ NSX sản xuất nguyên liệu

(8)

Nước sản xuất

(9)

Bicelor

VD-15765-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefaclor

USP38

1/ Lupin Limited - India.

1/ 198-202 New industrial Are No.2, Mandideep - 462046, District: Kaisen - India

1/ India

2/ DSM Sinochem pharmaceuticals India Private Limited - India.

2/ Bhai Mohan Singh Nagar, Toansa, Distt. Nawanshahr, Punjab 144 533 India.

2/ India

Fabadroxil

VD-15801-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefadroxil hemihydrate

USP38

1/ Lupin Limited - India

1/- Word: 124,GIDC Estate, Ankleshwar 393002 (Gujarat) - Corporate poffice: 159 CST Road, Kalina, Santacruz (E) Mumbai 400 098. India

1/ India

2/ DSM Synochem pharmaceuticals Spain S.A (Spain)

2/ Ripollès (Pol. Ind. Can Bernadaes-Subira), 2. 08130. Santa Perpetua de Mogoda, Barcelona

2/ Spain

Fabafixim 400

VD-15805-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefixime trihydrate

USP38/ DĐVN IV

1/ Parabolic drugs ltd- INDIA

1/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Nectar lifescience ltd- India

2/ SCO-38,39, Sector 9- D Chandigarh-160 009 (INDIA)

2/ India

3/ Covalent Laboratories Private Ltd.

3/ Survey No - 374, Gundalamachnoor Village, Hathnoor Mandal, Gundla Machanur Road, Medak District, Telangana 502296, India

3/ India

Trikazim

VD-15836-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Ceftazidime with Sodium carbonate (Sterile Ceftazidime with Sodium carbonate)

USP38

1/ Qilu Antibiotics Pharmaceutical Co, Ltd. - China

1/No 849 Dongjia Town, Licheng dist, Jinan, China

1/China

2/ Harbin Pharmaceutical Group Co.,Ltd- China

2/2 Longshun st, Nangang No188 Gongnong road

2/China

Bicelor 500

VD-15768-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefaclor

USP38

1/ Lupin Limited - India

1/ 198-202 New industrial Are No.2, Mandideep - 462046, District: Kaisen - India

1/ India

2/ DSM Sinochem pharmaceuticals India Private Limited - India

2/ Bhai Mohan Singh Nagar, Toansa, Distt. Nawanshahr, Punjab 144 533 India.

2/ India

Gasterol (Hydrocortison natri succinat tương đương Hydrocortison 100mg)

VD-15820-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Hydrocortisone Sodium succinate

NSX

1/Crystal pharma - Spain

1/ Parque Tecnologico de Boecillo. Parcela 105.47.151 Poecillo Valladolid - Spain

1/Spain

2/ BIOFER S.p.A.

2/ Via Canina, 2 - 41036 Medolla ( MO) ITALY

2/ Italy

Fabafixim 200

VD-15804-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefixime trihydrate

USP38/ DĐVN IV

1/ Parabolic drugs ltd- INDIA

1/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh -160017(INDIA)

1/ India

2/ Nectar lifescience ltd- India

2/ SCO-38,39, Sector 9-D Chandigarh-160 009 (INDIA)

2/ India

3/ Covalent Laboratories Private Ltd.

3/ Survey No - 374, Gundalamachnoor Village, Hathnoor Mandal, Gundla Machanur Road, Medak District, Telangana 502296, India

3/ India

Fabafixim 50

VD-15807-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefixime trihydrate

USP38/ DĐVN IV

1/ Parabolic drugs ltd- INDIA

1/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Nectar lifescience ltd- India

2/ SCO-38,39, Sector 9- D Chandigarh-160 009 (INDIA)

2/ India

3/ Covalent Laboratories Private Ltd.

3/ Survey No - 374, Gundalamachnoor Village, Hathnoor Mandal, Gundla Machanur Road, Medak District, Telangana 502296, India

3/ India

Fabafixim 50 (Cefixim 50mg)

VD-15806-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefixime trihydrate

USP38/ DĐVN IV

1/ Parabolic drugs ltd- INDIA

1/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Nectar lifescience ltd- India

2/ SCO-38,39, Sector 9- D Chandigarh-160 009 (INDIA)

2/ India

3/ Covalent Laboratories Private Ltd

3/ Survey No - 374, Gundalamachnoor Village, Hathnoor Mandal, Gundla Machanur Road, Medak District, Telangana 502296, India

3/ India

Fabapoxim 200 (Cefpodoxim proxetil tương đương Cefpodoxim 200mg

VD-15809-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefpodoxime proxetil

USP38

1/ Parabolic drugs ltd-INDIA

1/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Covalent Laboratories Private Ltd.

2/ Survey No - 374, Gundalamachnoor Village, Hathnoor Mandal, Gundla Machanur Road, Medak District, Telangana 502296, India

2/ India

Fabapoxim 100

VD-15808-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefpodoxime proxetil

USP38

1/ Parabolic drugs ltd-INDIA

1/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Covalent Laboratories Private Ltd.

2/ Survey No - 374, Gundalamachnoor Village, Hathnoor Mandal, Gundla Machanur Road, Medak District, Telangana 502296, India

2/ India

Fabapoxim 50

VD-15810-11

7/11/2017

CTCP Dược phẩm Trung ương 1

Cefpodoxime proxetil

USP38

1/ Parabolic drugs ltd-INDIA

1/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Covalent Laboratories Private Ltd.

2/ Survey No - 374, Gundalamachnoor Village, Hathnoor Mandal, Gundla Machanur Road, Medak District, Telangana 502296, India

2/ India

Trikadinir

VD-15833-11

7/11/2017

CTCP Dược phẩm Trung ương 1

Cefdinir

USP38

1/ Nectar lifesciences ltd- India

1/ Village Saidpura, Tehsil Derabassi, District S.A.S Nagar (Mohali)

1/ India

2/Parabolic drugs ltd INDIA

2/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017, INDIA.

2/ India

3/ Covalent Laboratories Private Limited

3/ Factory: Survey No. 374, Gundla Machanoor Village, Hathnoor mandal, Medal Dist - 502 296, Telangana, India

3/ India

Ceftume 125

VD-15784-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefuroxime axetil

USP38

1/ Parabolic drugs ltd- INDIA

1/SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Nectar lifescience ltd- India

2/ Village Saidpura, Tehsil Derabassi, District S.A.S Nagar (Mohali) 2.SCO 99-100, Level

2/ India

3/ Covalent Laboratories Private Ltd.

3/ Survey No. 374, Gundla Machanoor Village, Hathnoor Mandal, Medak Dist, Telangana, INDIA.

3/ India

Ceftume 500 (Cefuroxim axetil tương đương Cefuroxim 500mg)

VD-15787-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefuroxime axetil

USP38

1/ Parabolic drugs ltd-INDIA

1/SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017(INDIA)

1/ India

2/ Nectar lifescience ltd- India

2/ Village Saidpura, Tehsil Derabassi, District S.A.S Nagar (Mohali) 2.SCO 99-100, Level

2/ India

3/ Covalent Laboratories Private Ltd.

3/ Survey No. 374, Gundla Machanoor Village, Hathnoor Mandal, Medak Dist, Telangana, INDIA.

3/ India

Lady-Gynax

VD-15821-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Nystatin

BP2016/ USP38

1/ Vuab phar a.s - Czech Republic

1/ Vltavska 53,252 63 Roztoky Czech Republic

1/ Czech Republic

2/ Antibiotice SA-Romania

2/ 1, Valea Lupulu street lasi 707410 Romania

2/Romania

3/ DSM- The United Kingdom

3/ Dalry Ayshire-Scotland

3/ The United Kingdom

Spiramycin 1.5M.I.U

VD-15828-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Spiramycin

DĐVN IV /BP2016

1/ Wuxi Fortune Pharmaceutical Co., Ltd.-China.

1/ No.257, Xicheng Road, Wuxi, Jiangsu 214041

1/ China

2/Henan Topfond Pharmaceutical Co., Ltd.-China.

2/ No. 2, Guangming Road, Yicheng, Zhumadian, Henan, China

2/ China

Spiramycin 3 M.I.U

VD-15829-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Spiramycin

DĐVN IV /BP2016

1/ Wuxi Fortune Pharmaceutical Co., Ltd.-China.

1/ No.257, Xicheng Road, Wuxi, Jiangsu 214041

1/ China

2/Henan Topfond Pharmaceutical Co., Ltd.-China.

2/ No. 2, Guangming Road, Yicheng, Zhumadian, Henan, China

2/ China

Trikadinir 300

VD-15835-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefdinir

USP38

1/ Nectar lifesciences ltd - India

1/ Village Saidpura, Tehsil Derabassi, District S.A.S Nagar (Mohali)

1/ India

2/Parabolic drugs ltd INDIA

2/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017, India.

2/ India

3/ Covalent Laboratories Private Limited

3/ Factory: Survey No. 374, Gundla Machanoor Village, Hathnoor mandal, Medal Dist - 502 296, Telangana, India

3/ India

Trikadinir 100

VD-15834-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefdinir

USP38

1/ Nectar lifesciences ltd- India

1/ Village Saidpura, Tehsil Derabassi, District S.A.S Nagar (Mohali)

1/ India

2/Parabolic drugs ltd INDIA

2/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017, INDIA.

2/ India

3/ Covalent Laboratories Private Limited

3/ Factory: Survey No. 374, Gundla Machanoor Village, Hathnoor mandal, Medal Dist - 502 296, Telangana, India

3/ India

Bravine Inmed

VD-15832-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefdinir

USP38

1/ Nectar lifesciences ltd- India

1/ Village Saidpura, Tehsil Derabassi, District S.A.S Nagar (Mohali)

1/ India

2/Parabolic drugs ltd INDIA

2/ SCO 99-100, Level III & IV, Sector 17-B, Chandigarh - 160017, India.

2/ India

3/ Covalent Laboratories Private Limited

3/ Factory: Survey No. 374, Gundla Machanoor Village, Hathnoor mandal, Medal Dist - 502 296, Telangana, India

3/ India

Lansoprasol 15

VD-15822-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Lansoprazole

NSX

1/ Amoli Organics pvt. ltd - India.

1/ 407, Dalamal House Jamnalal Bajaj Rd, Nariman Point Mumbai Maharashtra - India

1/ India

2/ Smilax laboratories limited - India

2/ Banjara Hills, Hyderabad, Telangana

2/ India

3/ Zen biotech pvt. ltd - India

3/ Plot No. 195/4, PhaseII, Sector-3, Line 7, IDA, Cherapally, Hyderabad - 500051, Telangana, India

3/ India

Lansoprasol 30

VD-15823-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Lansoprazole

NSX

1/ Amoli Organics pvt. ltd - India.

1/ 407, Dalamal House Jamnalal Bajaj Rd, Nariman Point Mumbai Maharashtra - India

1/ India

2/ Smilax laboratories limited - India

2/ Banjara Hills, Hyderabad, Telangana

2/ India

3/ Zen biotech pvt. ltd - India

3/ Plot No. 195/4, PhaseII, Sector-3, Line 7, IDA, Cherapally, Hyderabad - 500051, Telangana, India

3/ India

Cefradin 500mg

VD-15783-11

7/11/2017

CTCP Dược phẩm Trung ương 1 - Pharbaco

Cefradin

DĐVN IV/ BP2016

DSM Synochem pharmaceuticals Spain S.A (Spain)

Ripollès (Pol. Ind. Can Bernadaes-Subira), 2. 08130. Santa Perpetua de Mogoda, Barcelona

Spain