Regulatory Affairs

We possess capabilities for preparing, Technical Dossiers and Drug Master Files (DMFs) for a range of our products. Our facilities are constantly upgraded to comply with European and US Regulatory inspections, making us strategically poised to enter Regulated Markets and ROW Markets.

Registered Products

No.	Country	Products Registerd
1	Jamaica	96
2	Panama	6
3	Trinidad & Tobago	13
4	Honduras	30
5	Cuba	30
6	DR	29
7	Philippines	11
8	Bolivia	3
9	Elsavador	12
10	Guyana	86
11	Nigeria	2
12	Costa Rica	3
13	Maldives	6
14	Nicaragua	4
15	Sri Lanka	18
16	Turkmenistan	4
17	Kyrgyzstan	5
18	Guatemala	4
19	Myanmar	1
20	Paragway	6
21	Botswana	1
22	Bhutan	3
23	Cambodia	4
24	Mongolia	7
25	Namibia	1
26	Mauritius	9
27	Tajikistan	3
	TOTAL	397

Submitted Products

No.	Country	Products Sumitted
1	Jamaica	12
2	Panama	8
3	Trinidad & Tobago	15
4	Honduras	37
5	Cuba	6
6	DR	31
7	Guyana	30
8	Costa Rica	4
9	Nicaragua	8
10	Sri Lanka	10
11	Turkmenistan	1
12	Guatemala	16
13	Myanmar	24
14	Botswana	4
15	Bhutan	9
16	Cambodia	4
17	Mongolia	6
18	Peru	1
19	Burundi	3
20	Namibia	9
21	Vietnam	1
22	Ecuador	3
23	Peru	1
24	Burundi	3
25	Zimbabwe	3
26	Laos	5
27	Malaysia	1
	TOTAL	255

Pipeline Products

Sr No	Country	Products in Pipeline
1	Jamaica	25
2	Panama	10
3	Trinidad & Tobago	1
4	Honduras	26
5	Cuba	58
6	DR	10
7	Philippines	2
8	Bolivia	5
9	Guyana	5
10	Nigeria	4
11	Costa Rica	36
12	Nicaragua	12
13	Sri Lanka	15
14	Guatemala	27
15	Myanmar	25
16	Bhutan	15
17	Azerbaijan	5
18	Cambodia	18
19	South Africa	4
20	Mongolia	2
21	Peru	3
22	Burundi	2
23	Namibia	5
24	Armenia	13
25	Togo	5
26	Kenya	3
27	Tajikistan	1
28	Peru	3
29	Burundi	2
30	Zimbabwe	5
31	Laos	5
32	Syria	6
33	Madagascar	13
	TOTAL	371

CTD Dossiers

Ear And Eye Drops

No.	Product (Ear And Eye Drops)
1	METRONIDAZOLE INJECTION USP - 0.5% w/v
2	Paracetamol INV INF 10mg /ml
3	CYCLOPHOSPHAMIDE FOR INJECTION USP 1g/Vial
4	Dexamethasone Sodium phaosphate Inj BP 4mg /ml
5	Nitroglycerin Inj USP 5mg /ml
6	Sodium Chloride INV INF BP 0.9%
7	Oxytocin Inj BP 5IU/ml
8	Progesteron Inj USP 25mg /ml
9	Propofol Injrction BP 10mg /ml
10	Ringer lacatate INV INF ( Compound Sodium Lactate Intravenous Infusion BP)
11	Dextrose INV INF 5% USP
12	Dextrose INV INF 25% USP
13	Aciclovir Sodium For Inj BP INV INF 250mg
14	AMPHOTERICIN- B FOR INJECTION USP 50 mg
15	Ceftadizime For Inj USP 1g
16	Cyproheptadine tab BP 4mg
17	Vitamin B Complex Injection IH
18	Amikacin Inj USP 500mg
19	Atracurium Besilate Inj USP 10mg
20	Azithromycin For Inj 500mg
21	CLINDAMYCIN PHOSPHATE INJECTION 150 mg BP
22	DEXTROSE INJECTION 50 % w/v USP
23	Ergometrine maleate Inj BP 0.5mg /ml
24	frusamide Inj BP 10mg/ml
25	Heparin Injecion BP 1000IU
26	Heparin Injecion BP 5000IU
27	Pantoprazol For Inj 40mg IH
28	Raboprazole For Inj 20mg IH
29	Vancomycin Hycdrochloride For Inj 1g
30	Vancomycin Hycdrochloride For Inj 500mg
31	VECURONIUM BROMIDE FOR INJECTION 4 mg
32	Chloramphenicol Ear Drop BP 5%
33	Chloramphenicol Opthalmic Solution USP 0.5%
34	Ciprofloxacin Opthalmic Solution USP 0.3%
35	CITICOLINE INJECTION 250 mg/ml IH
36	AMPHOTERICIN- B FOR INJECTION USP 50 mg
37	DOCETAXEL INJECTION 20 MG/0.5 ML
38	DOCETAXEL INJECTION 80 MG/2 ML
39	MENOTROPHIN FOR INJECTION BP 75 IU)
40	Esomeprazole For Inj 40mg
41	Teicoplanin for injection 400 mg
42	Bleomycin for Injection USP 15 IU
43	Docetaxel Injection Concentrate 80 mg/ 2.0 ml
44	Iopamidol Injection USP 300 mg
45	OCTREOTIDE INJECTION 50 mcg
46	Pemetrexed For Injection 500 mg
47	PROGESTERONE INJECTION USP 100 mg
48	PROGESTERONE INJECTION USP 50 mg
49	PROGESTERONE INJECTION USP25 mg
50	Tigecycline for Injection 50mg per ml
51	Tigecycline for Injection 50mg per ml
52	TOBRAMYCIN INJECTION USP 40 MG
53	Dexamethasone Eye Ear Drops /Dexamethasone Sodium Phaosphate Inj USP 0.1%
54	Docetaxel Injection Concentrate 20mg /0.5ml
55	CARBOPLATIN INJECTION BP 150mg per 15ml
56	CARBOPLATIN INJECTION BP 450mg per 45ml
57	Dimenhydrinate Injection USP 50 mg
58	Etoposide Injection USP 100 mg/ 5.0 mL
59	Omeprazole for Injection 40 mg
60	Fluphenazine Decanate Inj BP 25mg per ml
61	HALOPERIDOL INJECTION BP 5 mg
62	HYDRALAZINE HYDROCHLORIDE INJECTION USP 20 mg/ml
63	Hydrocortisone Sodium Succinate For inj BP 1oomg
64	Iron dextran Inj USP 50mg per ml
65	IRON SUCROSE INJECTION USP 20mg per ml
66	Leucovorin Calcium Injection USP 50 mg/ 5.0mL
67	Methotrexate Injection BP 50 mg/ 2.0mL
68	Methyl Prednisolone Sodium Succinate Injection USP 500mg
69	Methyl Prednisolone Sodium Succinate Injection USP 1g
70	Paclitaxel Injection USP 30 mg. / 5 ml
71	Paclitaxel Injection USP100 mg./ 16.7 ml
72	Paclitaxel Injection USP 260 mg./ 43.4 ml
73	TOBRAMYCIN opthalmic solution USP 0.3%
74	DACARBAZINE FOR INJECTION USP 200mg
75	NITROGLYCERINE INJECTION USP 5mg per ml
76	SUXAMETHONIUM CHLORIDE INJECTION BP
77	Gentamycin Eye ear drops 0.3%
78	Gemcitabine for Injection USP 1 g
79	Gemcitabine for Injection USP 2oomg
80	Teicoplanin for Injection 400 mg
81	Zoledronic Acid for Injection 4.0 mg
82	Salbutamol Pressurised Inhalation BP 100mcg
83	Beclometasone Pressurised Inhalation BP 50mcg
84	DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP 4 mg/mL
85	Lidocaine Hydrochloride Injection USP 20mg
86	Caspofungin Acetate for Injection 50 mg
87	Caspofungin Acetate for Injection 70 mg
89	Ranitidine Injection USP 25mg
90	THIOPENTONE SODIUM FOR INJECTION BP 500 mg
91	MENOTROPHIN FOR INJECTION BP 150 IU
92	Neostigmine Metilsulfate Inj BP 0.5mg per ml
93	Promethazine HCL Inj BP 25mg per ml
94	Rabeprazole for Injection 20 mg
95	Bupivacaine Injection BP 5 mg
96	Oxyplatin Injection 100mg
97	Oxaliplatin Injection 50mg/25ml
98	Hydrocortisone Sodium Succinate for Injection BP 500 mg
99	Protamin Sulphate Inj BP 10mg
100	Pralidoxim Chloride for Inj IP 1g per vial
101	Isoxsuprine Hydrochloride Inj USP 5mg
102	CITICOLINE INJECTION 250 mg/ml
103	Sterile Piperacillin Sodium and Tazobactam Sodium (81) 2.25g
104	Sterile Piperacillin Sodium and Tazobactam Sodium (81) 4.5g
105	Meropenum for injection 500mg & 1g
106	Xylometazoline HCL Nasal Drops 0.1% & 0.05%
107	Cetrorelix injection 0.25 mg/vial
108	Dobutamin HCL Inj 12.55mg
109	Dobutamin Inj USP 250mg per vial lyophillised
110	Hyoscine Butyl Bromide Inj BP 20mg
111	Isoxsuprine HCL Injection USP 5 mg
112	Clonidine Injection BP 0.15mg /ml
113	Rabeprazole Sodium for Injection 20 mg
114	IOPROMIDE INJECTION USP (300 MGI/ML)
115	CARBOXYMETHYL CELLULOSE SODIUM Eye drops 0.5%
116	DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM INJECTION USP
117	Mensa injection 400mg per 4 ml
118	ACETYL CYSTEINE SOLUTION USP 200 mg
119	DORIPENEM FOR INJECTION 500 mg
120	Pentoprazole For Inj 4omg --Pentoking
121	Oxytocin Inj BP 10IU/ml
122	Diclofenac Sodium Inj 25mg per ml
123	GENTAMICIN SULPHATE INJECTION BP 40MG/ML
124	Iopamidol Injection USP 300mg
125	Iopamidol Injection USP 370mg
126	IRINOTECAN HYDROCHLORIDE FOR INJECTION 100MG/5ML
127	Droperidol Inj USP 2.5mg/ml

Cream Ointment & Gel

No.	Product ( Cream Ointment & Gel )
1	Diclofenac Gel BP 1%
2	DERMAZONE-BG (Gentamicin + Beclomethasone + Clotrimazole Cream)

Tablet & Capsules

No.	Product ( TABLET & CAPSULES)
1	FLUTAMIDE TABLET USP 250MG
2	MERCAPTOPURINE TABLETS B.P. 50 mg
3	CYPROHEPTADINE TABLET BP 4MG
4	METHOTREXATE TABLETS B.P. 2.5 mg
5	Misoprostol 200 mcg Tablet
6	TAMOXIFEN TABLETS BP 20 mg
7	Amoxicillin Capsule BP 500mg
8	Ampicillin capsule BP 500mg
9	Cloxacillin Sodium Capsule USP 500mg
10	Capecitabine Tablets USP 500 mg
11	CEPHALEXIN CAPSULE B.P. 500 mg
12	Metformin Hydrochloride Tab 500 mg Extended release
13	Artemether 20mg and Lumefantrine 120mg Tablets
14	Leflunomide tab 20mg IH
15	Doxasosin Tab USP 2mg
16	CABERGOLINE TABLETS USP 0.5 mg
17	HYDROXYUREA CAPSULES 500 MG
18	Letrozole tablet 2.5mg
19	Mefloquine Hydrochloride Tablets USP 250 mg
20	Naltrexone Hydrochloride Tablets USP 50 mg
21	TAMOXIFEN CITRATE TABLETS B.P.20mg
22	THALIDOMIDE CAPSULES USP 100 mg
23	Pregabalin Capsules 75mg
24	CLOPIDOGREL TABLETS USP 75 mg
25	Perindropil Tab 4mg
26	Sulfamethaxazole & Trimethoprim Tab ( Co-Trimazole tab BP )
27	Clotrimazole Vaginal Ovules USP 100 mg
28	Ranitidine Tablets B.P. 150 mg
29	Ranitidine Tablets B.P. 300 mg
30	Valsartan Tablets USP 160 mg
31	Valsartan Tablets USP 320 mg
32	Valsartan Tablets USP 80 mg
33	CEFALEXIN CAPSULES BP 250mg
34	CEFALEXIN CAPSULES BP 500mg
35	Tibolone Tablets 2.5 mg
36	Desogestrel 0.15 mg and Ethinylestradiol 0.02 mg USP Tablets
37	Desogestrel 0.15 mg and Ethinylestradiol 0.03 mg USP Tablets
38	Levonorgestrel BP 0.75 mg Tablets
39	Levonorgestrel BP 1.5 mg Tablets
40	Levonorgestrel 0.10 Mg & Ethinylestradiol 0.02 Mg Tablets BP
41	Levonorgestrel 0.15 Mg & Ethinylestradiol 0.03 Mg Tablets BP
42	Levonorgestrel 0.25 Mg & Ethinylestradiol 0.05 Mg Tablets BP
43	Medroxy Progesterone Acetate Tablets USP 10 mg
44	MEGESTROL ACETATE 40 MG tablet USP
45	Pyridostigmine Tablets BP 60 mg
46	CIPROFLOXACIN TABLET BP 500 mg
47	CIPROFLOXACIN TABLET BP 250 mg
48	Carbimazole Tablet BP 5mg
49	Valsartan 80mg and Hydrothiozide 12.5mg tab USP
50	Sildenafil tablet 50 mg
51	Alendronate Sodium tablet 70mg
52	Pravastatin Tablets BP 40mg
53	Nitroglycerin tablet 0.3mg
54	THALIDOMIDE CAPSULES USP 50 mg
55	Metformin Hydrochloride Tab BP 500 mg
56	Metformin Hydrochloride Tab BP 850 mg
57	Azithromycin Tab 250mg USP
58	Genfitnib Tablets 250mg IH
59	Erlotinib Tab 100mg & 150mg
60	FLUCLOXACILLIN CAPSULES BP 500 MG
61	Frusemide Tablet 40mg
62	Spiramycin Tablet 1.5MIU
63	Spiramycin Tablet 3.0MIU
64	Danazole Capsule 200mg
65	Paracetamol Tablets 500mg
66	Amlodipine Besylate Tablets USP 5 mg
67	Levothyroxin tab BP 25mcg
68	Levothyroxin tab BP 50mcg
69	Levothyroxin tab BP 100mcg
70	Rifampicin Capsule USP 150mg
71	Tranexamic Acid Capsules 500 mg
72	LETROZOLE TABLETS USP 2.5 MG
73	Gefitinib Tab 250mg
74	Carisoprodol Tablets USP 350 mg

Liquid Oral

No.	Product ( LIQUID ORAL)
1	Amocicillin Oral Suuspension BP 250mg /5ml
2	Calcium Polystyrene Sulfonate Powder for Suspension
3	Sodium Polystyrene Sulfonate Powder for Suspension USP
4	Povidone Iodine Topical Solution USP 10 % w/v
5	Allumina , Magnesium & Simeticon Suspension
6	Isoflurane, Concentrate for Inhalation Solution
7	Isoflurane, Concentrate for Inhalation Solution
8	Sevoflurane Solution 99.99%

Drug Shortage

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Registered Office

1204 & 1302, Rupa Solitaire ,
     Plot No A-1, Sector – 1,
     MBP, T.T.C. Indl, Mahape,
     Navi Mumbai-400701
022 4065 9200 (Board)
022 4065 9228 (Marketing)
flagship@flagshipbiotech.com

Regulatory Affairs

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Drug Shortage

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