| View |
|
BR-851
|
Bacillus Calmette-Guerin Vaccine (Live, Attenuated)
|
SII-Onco-BCG
|
40 mg/mL
|
Lyophilized Powder for Intravesical Instillation
|
Prescription Drug (RX)
|
Single dose. 4 mL Type I amber glass vial (Box of 3
monocartons in a carton)
|
-
|
Serum Institute of India Pvt. Ltd.
|
India
|
|
SMHP Marketing & Consultancy
|
SMHP Marketing & Consultancy
|
Initial [Variation]
|
18 December 2023
|
18 December 2028
|
| View |
|
BR-853
|
Denosumab
|
Xgeva
|
70 mg per mL
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
1.7 mL in 3 mL Type I glass vial with a butyl rubber stopper and an aluminum seal with a plastic flip-off dust cover (Box of 1's)
|
-
|
Amgen Manufacturing Limited
|
U.S.A
|
N/A
|
Zuellig Pharma Corporation
|
Zuellig Pharma Corporation
|
Initial
|
30 August 2023
|
30 August 2028
|
| View |
|
BR-856
|
Enoxaparin Sodium
|
Olxarin
|
2,000 IU/0.2 mL (20mg/0.2 mL)
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
0.2 mL Borosilicate Glass Pre-filled Syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
04 August 2021
|
04 April 2025
|
| View |
|
BR-857
|
Enoxaparin Sodium
|
Olxarin
|
8,000 IU/0.8mL (80mg/0.8mL)
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
0.8 mL Borosilicate Glass Pre-filled Syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
04 August 2021
|
04 April 2025
|
| View |
|
BR-858
|
Enoxaparin Sodium
|
Olxarin
|
6,000 IU/0.6mL (60 mg/0.6mL)
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
0.6 mL Borosilicate Glass Pre-filled Syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
04 August 2021
|
04 April 2025
|
| View |
|
BR-859
|
Recombinant Human Erythropoietin Alfa
|
Eposis
|
2000 I.U./0.5mL
|
Solution For Injection (I.V./S.C.)
|
Prescription Drug (RX)
|
0.5mL pre-filled Type I glass syringe with needle in individually sealed plasctic tray per box of 6's
|
Hematopoietic Growth Factor
|
Daewoong Pharmaceutical Co., Ltd.
|
Korea
|
|
New Marketlink Pharmaceutical Corporation
|
New Marketlink Pharmaceutical Corporation
|
Renewal
|
21 April 2022
|
16 April 2027
|
| View |
|
BR-860
|
Enoxaparin Sodium
|
Olxarin
|
4,000 IU/0.4mL (40 mg/0.4 mL)
|
Solution For Injection (Sc)
|
Prescription Drug (RX)
|
0.4 mL Pre-filled glass syringe with Rubber Stopper and Plunger Rod (Box of 2's)
|
-
|
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
|
China
|
|
Sahar International Trading, Inc.
|
Sahar International Trading, Inc.
|
Initial
|
04 August 2021
|
17 April 2025
|
| View |
|
BR-868
|
Recombinant Human Erythropoietin Alfa
|
Eposis
|
10,000 I.U./mL
|
Solution For Injection (I.V./S.C.)
|
Prescription Drug (RX)
|
1mL pre-filled Type I glass syringe with needle in individually sealed plastic tray
|
Hematopoietic Growth Factor
|
Daewoong Pharmaceutical Co., Ltd.
|
Korea
|
|
New Marketlink Pharmaceutical Corporation
|
New Marketlink Pharmaceutical Corporation
|
Automatic Renewal
|
01 April 2022
|
17 May 2027
|
| View |
|
BR-869
|
Human Rabies Immunoglobulin
|
Berirab P
|
300 IU/2 mL (150 IU/mL)
|
Solution for Injection (IM)
|
Prescription Drug (RX)
|
2 mL Type I pre-filled glass syringe + 1 separate needle 216 1/2" in sealed plastic tray (Box of 1's)
|
-
|
CSL Behring GmbH
|
Germany
|
N/A
|
Zuellig Pharma Corporation
|
Zuellig Pharma Corporation
|
-
|
27 April 2022
|
04 June 2027
|
| View |
BR-862_PI_01.pdf
|
BR-862
|
Belimumab
|
Benlysta
|
120 mg vial Each vial contains a sufficient amount of belimumab to deliver 120 mg in 1.5 mL when reconstituted as recommended with sterile Water for Injections. After reconstitution, each mL of solution contains 80 mg belimumab.
400 mg vial Each vial contains a sufficient amount of belimumab to deliver 400 mg in 5.0 mL when reconstituted as recommended with sterile Water for Injections. After reconstitution, each mL of solution contains 80 mg belimumab.
|
Powder for Solution for Injection (IV Infusion)
|
Prescription Drug (Rx)
|
Single dose. 5 mL (120 mg/vial) USP Type I glass
vial with chlorobutyl rubber stopper, sealed with aluminum crimp and flip-off cap (Box of l’s)
Single dose. 20 mL (400 mg/vial) USP Type I glass vial with chlorobutyl rubber stopper, sealed with aluminum crimp and flip-off cap (Box of 1’s)
|
-
|
GlaxoSmithKline Manufacturing S.P.A.
|
Italy
|
|
GlaxoSmithKline Philippines Inc.
|
GlaxoSmithKline Philippines Inc.
|
Initial
|
12 October 2021
|
17 April 2025
|
| View |
|
BR-870
|
Filgrastim (Recombinant Granulocyte Colony-Stimulating Factor [Rhu-Gcsf])
|
Scilocyte
|
300 mcg/mL
|
Solution For Injection (Sc/IV)
|
Prescription Drug (RX)
|
1 mL Prefilled Type I glass syringe per box
|
Hematopoietic Growth Factor
|
Intas Pharmaceuticals Limited (Biopharma Division)
|
India
|
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal
|
27 June 2022
|
29 June 2027
|
| View |
|
BR-871
|
Follitropin Alfa
|
Gonal-F
|
1,050 IU/1.75 mL (77 mcg/1.75 mL)
|
Lyophilized Powder for Solution for Injection (S.C.)
|
Prescription Drug (RX)
|
3 mL Type I glass vial containing the lyophilized powder + 2 mL pre-filled syringe containing the diluent (Bacteriostatic Sterile Water for Injection) + 15 pieces 1 mL empty syringe per box
|
-
|
Merck Serono S.p.A
|
Italy
|
N/A
|
Merck, Inc.
|
Merck, Inc.
|
-
|
18 March 2022
|
26 July 2027
|
| View |
|
BR-874
|
Human Normal Immunoglobulin (Igiv)
|
Humoglob
|
50mg/mL
|
Solution For Injection (Iv Infusion)
|
Prescription Drug (RX)
|
50 mL Glass Vial
|
Immune sera and Immunoglobulin
|
SK Plasma Co. Ltd.
|
Korea
|
|
International Apex Pharmaceuticals Inc.
|
International Apex Pharmaceuticals Inc.
|
Automatic Renewal
|
06 September 2022
|
11 September 2027
|
| View |
|
BR-875
|
Cholera Vaccine (Inactivated, Oral)
|
Shanchol
|
Multicomponent/1.5mL
|
Oral Suspension
|
Prescription Drug (RX)
|
Single dose. Type I glass vial with Vaccine Vial Monitor x 1.5 mL (Box of 1's, 10's, and 35's)
|
-
|
Sanofi Healthcare India Private Limited
|
India
|
N/A
|
Sanofi Pasteur, Inc.
|
Zuellig Pharma Corporation
|
Renewal
|
29 December 2022
|
28 September 2027
|
| View |
|
BR-877
|
Live Measles, Mumps and Rubella Vaccine
|
M-M-R II
|
Formulation: After reconstitution, one dose (0.5 mL) contains: Measles virus? Enders' Edmonston strain (live, attenuated).. Mumps virus! Jeryl Lynn TM (B Level) strain (live, attenuated) ...... Rubella virus? Wistar RA 27/3 strain (live, attenuated) ....
....
..
.NLT 1,000 CCID 50 ..NLT 12,500 CCID 50 ....NLT 1,000 CCID 50
() Produced in chick embryo cells. (2) Produced in WI-38 human diploid lung fibroblasts.
|
Lyophilized Powder for Injection (IM/SC)
|
Prescription Drug (RX)
|
Single dose. Clear and colorless glass vial x 3 mL +
Type I pre-filled glass syringe (diluent) (0.75 ml water for injection) x 1 mL + 2 separate needles in a sealed clear plastic tray (Box of 10's)
|
-
|
Merck Sharp and Dohme Corp.
|
USA
|
|
Merck Sharp & Dohme (I.A.) LLC
|
Merck Sharp & Dohme (I.A.) LLC
|
Renewal
|
09 August 2022
|
24 July 2027
|
| View |
|
BR-879
|
Somatropin
|
Saizen
|
20 mg/ 2.5 mL (8 mg/mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
2.5 mL solution in 3 mL clear type I glass cartridge in a
sealed plastic tray (Box of 1's)
|
-
|
Merck Serono S.P.A
|
Italy
|
N/A
|
Merck, Inc.
|
Merck, Inc.
|
Renewal
|
07 September 2022
|
05 November 2027
|
| View |
|
BR-880
|
Somatropin
|
Saizen
|
6 mg/ 1.03 mL (5.83 mg/mL)
|
Solution For Injection (SC)
|
Prescription Drug (RX)
|
1.03 mL solution in 3 mL clear type I glass cartridge in a sealed plastic tray (Box of 1’s)
|
-
|
Merck Serono S.P.A
|
Italy
|
N/A
|
Merck, Inc.
|
Merck, Inc.
|
Renewal
|
07 September 2022
|
05 November 2027
|
| View |
|
BR-881
|
Recombinant Human Epidermal Growth Factor
|
Easyef
|
50mcg/mL (0.005%w/v)
|
Topical Solution (Spray)
|
Prescription Drug (RX)
|
10 mL plastic air-container (Box of l's)
|
-
|
Daewoong Pharmaceutical Co., Ltd.
|
Korea
|
|
Daewoong Pharma Philippines,Incorporated
|
Daewoong Pharma Philippines,Incorporated
|
-
|
17 February 2021
|
20 November 2025
|
| View |
|
BR-884
|
Clostridium botulinum neurotoxin type A
|
Retox
|
100 units
|
Lyophilized Powder for Injection (IM)
|
Prescription Drug (RX)
|
Type I Clear and Colorless Single Use Glass Vial with White Flip-off Cap x 5 mL (Box of 1’s)
|
-
|
Hugel, Inc.
|
Korea
|
|
Endure Medical, Inc.
|
Endure Medical, Inc.
|
-
|
26 February 2021
|
29 November 2024
|
| View |
|
BR-885
|
Measles, Mumps and Rubella Vaccine (Live, Attenuated)
|
None
|
Formulation
Each dose (0.5 mL) contains:
Measles Virus (Edmonston-Zagreb Strain)....NLT 1000 CCID50 Mumps Virus (Leningrad-Zagreb Strain).......NLT 5000 CCID 50 Rubella Virus (Wistar RA 27/3 Strain)..NLT 1000 CCID 50
|
Lyophilized Powder for Injection (SC)
|
Prescription Drug (RX)
|
Multidose (5 doses). 50 mL amber glass vial+ 2.5 mL colorless glass ampoule (Sterile Water for Injection as diluent) [Box of 50's].
|
-
|
Serum Institute of India Pvt., Ltd.
|
India
|
N/A
|
Genpharm, Inc.
|
Genpharm, Inc.
|
Initial (Variation)
|
11 November 2022
|
11 November 2027
|