Gennex Pharma | Pharma Exports and Services

ABOUT US

Gennex pharma is a globally diversified healthcare company headquartered at Hyderabad, Andhra Pradesh, India. As an integrated healthcare solutions provider, we render services with high quality and excellence with international standards over wide range of healthcare areas.Gennex pharma is promoted by highly motivated, technically qualified, professionally experienced technocrats who are penchant for innovation, value addition and quality.

VISION

Our vision is to become a leading healthcare company across the globe by catering high quality solutions in healthcare, committed to quality and excellence and to improve the quality of the life of the patients suffering from various ailments like cancer.

MISSION

We develop and market healthcare products and render services across the globe through state-of-the-art technology with international standards. We focus on strategic business development through regulatory affairs, manufacturing, supporting clinical & BE Studies , undertaking liaisoning ,product technical support following highly stringent cGMP guidelines such as US FDA,EDQM,EMEA,ICH,WHO,CDSCO,MCC,TGA,PIC/S.

S.No	Product Category
1	Oncology Orals
2	OncologyInjections
3	Powder Injections
4	Tablets Dry Powder Suspensions
5	Special New Products

Oncology Orals

S.No	Oncology Orals (Tablets & Capsules)
1	Abiraterone Acetate Tablets 250 mg - 120's
2	Anastrazole Tablets 1 mg - 30's
3	Bicalutamide Tablets 50 mg - 30's, 28's
4	Bicalutamide Tablets 150 mg - 30's, 28's
5	Chlorambucil Tablets 2 mg - 30's
6	Chlorambucil Tablets 5 mg - 30's
7	Dasatinib Tablets 20 mg - 60's
8	Dasatinib Tablets 50 mg - 60's
9	Dasatinib Tablets 70 mg - 60's
10	Dasatinib Tablets 100 mg - 60's
11	Enzalutamide Capsules 40 mg - 120's
12	Everolimus Tablets 2.5 mg - 28's
13	Everolimus Tablets 7.5 mg - 28's
14	Fludarabine Phosphate Tablets 10 mg - 20's
15	Gefitinib Tablets 250 mg - 30's
16	Imatinib Capsules 100 mg - 120's
17	Lapatinib Tablets 250 mg - 42's
18	Letrozole Tablets 2.5 mg - 30's
19	Melphalan Tablets 2 mg - 25's
20	Melphalan Tablets 5 mg - 25's
21	Nilotinib Capsules 150 mg - 30's
22	Nilotinib Capsules 200 mg - 30's
23	Pazopanib Tablets 200 mg - 30's
24	Pazopanib Tablets 400 mg - 30's
25	Sunitinib Capsules 12.5 mg - 28's
26	Sunitinib Capsules 25 mg - 28's
27	Sunitinib Capsules 37.5 mg - 28's
28	Sunitinib Capsules 50 mg - 28's
29	Tamozolomide Capsules 5mg - 5's
30	Tamozolomide Capsules 20 mg - 5's
31	Tamozolomide Capsules 100 mg - 5's
32	Tamozolomide Capsules 120 mg - 5's
33	Tamozolomide Capsules 180 mg - 5's
34	Tamozolomide Capsules 250 mg - 5's
35	Afatinib Tablets 20 mg - 30's
36	Afatinib Tablets 30 mg - 30's
37	Afatinib Tablets 40 mg - 30's
38	Afatinib Tablets 50 mg - 30's
39	Anastrazole Tablets 1 mg
40	Capecitabine Tablets 150 mg - 60's, 120's
41	Capecitabine Tablets 500 mg - 60's, 120's
42	Cyclophosphamide Tablets 50 mg - 100's
43	Dasatinib Tablets 80 mg - 30's
44	Dasatinib Tablets 140 mg - 30's
45	Erlotinib Tablets 25 mg - 30's
46	Erlotinib Tablets 50 mg - 30's
47	Erlotinib Tablets 100 mg - 30's
48	Erlotinib Tablets 150 mg - 30's
49	Exemestane Tablets 25 mg - 30's
50	Flutamide Capsules USP 125 mg - 180's
51	Hydroxyurea Capsules 500 mg - 100's
52	Imatinib Tablets 100 mg - 90's, 30's
53	Imatinib Tablets 400 mg - 90's, 30's
54	Lenalidomide Capsules 2.5 mg - 30's
55	Lenalidomide Capsules 10 mg - 30's
56	Lenalidomide Capsules 15 mg - 30's
57	Lenalidomide Capsules 20 mg - 30's
58	Lenalidomide Capsules 25 mg - 30's
59	Leucovorin Calcium Tablets USP 25 mg - 25's
60	Methotrexate Tablets 2.5 mg - 30's
61	Methotrexate Tablets 5 mg - 30's
62	Ondansetron Tablets USP 4 mg - 30's
63	Ondansetron Tablets USP 8 mg - 30's
64	Regorafenib Tablets 40 mg - 28's
65	Regorafenib Tablets 400 mg - 28's
66	Tamoxifen Tablets 10 mg - 60's, 30's
67	Tamoxifen Tablets 20 mg - 60's, 30's
68	Thalidomide Capsules USP 50 mg 30's
69	Thalidomide Capsules USP 100 mg 30's

Oncology Injections

S.No	Oncology Injections (Lyophilized & Liquid)
1	Carboplatin Injection BP 50 mg
2	Carboplatin Injection BP 150 mg
3	Carboplatin Injection BP 450 mg
4	Cisplatin Injection BP 150 mg
5	Irinotecan HCl Injection 40 mg
6	Irinotecan HCl Injection 100 mg
7	Placlitaxel Injection USP 30 mg
8	Placlitaxel Injection USP 50 mg
9	Placlitaxel Injection USP 100 mg
10	Placlitaxel Injection USP 260 mg
11	Placlitaxel Injection USP 300 mg
12	Bleomycin for Injection USP 15mg
13	Bleomycin for Injection USP 30 mg
14	Daunorubicin HCl for Injection USP 20 mg
15	Bortezomib for Injection 2 mg
16	Bortezomib for Injection 3.5 mg
17	Docetaxel Injection USP 20 mg
18	Docetaxel Injection USP 80 mg
19	Docetaxel Injection USP 120 mg
20	Vincristine Sulphate Injection USP 1.0 mg
21	Palonosetron Injection 0.25 mg
22	Temazolomide for Injection 100 mg
23	Azacitidine for Injection 100 mg
24	Cabazitaxel Injection 60 mg
25	Fulvestrant Injection 250 mg
26	Decetabine for Injection 50 mg
27	L-Asparaginase for Injection 5000 IU
28	L-Asparaginase for Injection 10000 IU
29	Leuprolide Acetate Depot Injection 3.75 mg
30	Leuprolide Acetate Depot Injection 11.25 mg
31	Mitomycin for Injection USP 5 mg
32	Mitomycin for Injection USP 20 mg
33	Mitomycin for Injection USP 40 mg
34	Vincristine Sulfate Injection USP 1 mg
35	Vinorelbine Injection USP 10 mg
36	Vinorelbine Injection USP 50 mg
37	Doxorubicin HCl for Injection USP 10 mg
38	Doxorubicin HCl for Injection USP 20 mg
39	Doxorubicin HCl for Injection USP 50 mg
40	Gemcitabine HCl for Injection 200 mg
41	Gemcitabine HCl for Injection 1000 mg
42	Oxaliplatin Injection USP 50 mg
43	Oxaliplatin Injection USP 100 mg
44	Cytarabine for Injection USP 500 mg
45	Cytarabine for Injection USP 1000 mg
46	Methotrexate Injection USP 50 mg
47	Methotrexate Injection USP 100 mg
48	Methotrexate Injection USP 200 mg
49	Methotrexate Injection USP 250 mg
50	Amifostine for Injection USP 500 mg
51	Cyclophosphamide for Injection USP 1000 mg
52	Cyclophosphamide for Injection USP 2000 mg
53	Epirubicin HCl for Injection 10 mg
54	Epirubicin HCl for Injection 50 mg
55	Epirubicin HCl for Injection 100 mg
56	Bendamustine HCl for Injection 25 mg
57	Bendamustine HCl for Injection 100 mg
58	Pemetrexed for Injection 100 mg
59	Pemetrexed for Injection 500 mg
60	Zoledronic Acid Concentrate for Solution for Injection 4mg
61	Bendamustine HCl for Injection 25 mg
62	Bendamustine HCl for Injection 100 mg
63	Carmustine for Injection 100 mg
64	Thiotera for Injection 15 mg
65	Idarubicin HCl Injection 5 mg
66	Idarubicin HCl Injection 20 mg
67	Leucovorin Calcium Injection USP 15 mg
68	Leucovorin Calcium Injection USP 50 mg
69	Methotrexate Injection USP 15 mg
70	Methotrexate Injection USP 50 mg
71	Methotrexate Injection USP 100 mg
72	Methotrexate Injection USP 500 mg
73	Methotrexate Injection USP 1000 mg
74	Pamidronate Disodium for Injection 30 mg
75	Pamidronate Disodium for Injection 60 mg
76	Pamidronate Disodium for Injection 90 mg
77	Vinblastine Sulfate for Injection USP 10 mg
78	Trabectedine Injection 0.25 mg
79	Trabectedine Injection 1.0 mg

Powder Injections

S.No	Powder Injections
1	Ceftriaxone for Injection 500 mg
2	Ceftriaxone for Injection 1000 mg
3	Cefotaxime for Injection 500 mg
4	Cefotaxime for Injection 1000 mg
5	Ceftazidime for Injection 500 mg
6	Ceftazidime for Injection 1000 mg
7	Cefuroxime for Injection 500 mg
8	Cefuroxime for Injection 1000 mg
9	Cefoxitin for Injection 1000 mg
10	Cefoxitin for Injection 2000 mg
11	Oxacillin for Injection 500 mg
12	Ertapenem for Injection 1000 mg
13	Doripenem for Injection 250 mg
14	Doripenem for Injection 500 mg
15	Meropenem for Injection 500 mg
16	Meropenem for Injection 1000 mg
17	Meropenem and Sulbactam for Injection 1500 mg (2:1)
18	Ceftriaxone and Sulbactam for Injection 750 mg (2:1)
19	Ceftriaxone and Sulbactam for Injection 1500 mg (2:1)
20	Ceftriaxone and Tazobactam for Injection 562.5 mg (8:1)
21	Ceftriaxone and Tazobactam for Injection 1125 mg (8:1)
22	Piperacillin and Tazobactam for Injection 2.25 gm (8:1)
23	Piperacillin and Tazobactam for Injection 4.5 gm (8:1)
24	Cefoperazone and Sulbactam for Injection 1000 mg (1:1)
25	Cefoperazone and Sulbactam for Injection 2000 mg (1:1)
26	Cefepime and Sulbactam for Injection 750 mg (2:1)
27	Cefepime and Sulbactam for Injection 1500 mg (2:1)
28	Cefepime and Sulbactam for Injection 3000 mg (2:1)
29	Cefotaxime and Sulbactam for Injection 750 mg (2:1)
30	Cefotaxime and Sulbactam for Injection 1500 mg (2:1)
31	Ceftazidime and Tazobactam for Injection 281.25 mg (8:1)
32	Ceftazidime and Tazobactam for Injection 1125 mg (8:1)
33	Ceftazidime and Sulbactam for Injection 750 mg (2:1)
34	Ceftazidime and Sulbactam for Injection 1500 mg (2:1)
35	Cefepime and Tazobactam for Injection 1125 (8:1) (1000+125)
36	Amoxicillin and Sulbactam for Injection 750 mg (2:1)
37	Amoxicillin and Sulbactam for Injection 1500 mg (2:1)
38	Amoxicillin and Clavulanate Potassium for Injection 600 mg (5:1)
39	Amoxicillin and Clavulanate Potassium for Injection 1200 mg (5:1)
40	Ampicillin and Cloxacillin for Injection 250 mg
41	Ampicillin and Cloxacillin for Injection 500 mg

Tablets Dry Powder Suspensions

S.No	Tablets & Dry Powder Suspensions
1	Amoxicillin & Clavulanate Potassium Tablets 375 mg
2	Amoxicillin & Clavulanate Potassium Tablets 625 mg
3	Amoxicillin & Clavulanate Potassium Tablets 1000 mg
4	Amoxicillin & Clavulanate Potassium for Oral Suspension 156.25 mg / 5 mL
5	Amoxicillin & Clavulanate Potassium for Oral Suspension 312.5 mg / 5 mL
6	Amoxicillin & Clavulanate Potassium for Oral Suspension 228.5 mg / 5 mL
7	Amoxicillin & Clavulanate Potassium for Oral Suspension 457 mg / 5 mL
8	Cefixime Dispersible Tablets 100 mg
9	Cefixime Dispersible Tablets 200 mg
10	Cefixime for Oral Suspension 50 mg / 5 mL
11	Cefpodoxime Proxetil Dispersible Tablets 100 mg
12	Cefpodoxime Proxetil Tablets 200 mg
13	Cefpodoxime Proxetil for Oral Suspension 100 mg / 5 mL
14	Cefuroxime Axetil Tablets 250 mg
15	Cefuroxime Axetil Tablets 500 mg

S.No	Special / New Products
1	Plerixafor Injection 20 mg / mL
2	Amoxicillin and Sulbactam Tablets 500 mg
3	Amoxicillin and Sulbactam Tablets 1000 mg
4	Amoxicillin and Sulbactam for Oral Suspension 250 mg / 5 mL
5	Amoxicillin and Sulbactam for Oral Suspension 500 mg / 5 mL
6	Diclofenac, Betamethasone and Hydraxocobalamin Injection 3.0 mL
7	Pantasone Polysulphate Capsules 100 mg

Services Category
Regulatory Services
eCTD Publishing and submission services
Regulatory Training & Guidance Services
Facility Design Services
Technology Transfer
Software Services

Regulatory Services

We undertake following Product Registration, Company Registration & GMP works:

Product Registration in Myanmar
Product Registration in Philippines
Philippines GMP
Product Registration in Ukraine
PIC/s / Ukraine GMP
Product Registration in Mozambique
Product Registration in Cambodia
Company Registration in Cambodia
Product Registration in Sri Lanka
Product Registration in Nigeria
Nigeria GMP (NAFDAC)
Product Registration in Kenya

We provide the Regulatory Services for following product categories:

Pharmaceutical (Human & Veterinary)
Nutraceutical,
Ayurveda,
Food & Cosmetic Products

Pre-Submission

Application for Brand Search.

Submission

Online / Physical dossier Submission to respective FDA

Post-Submission

Handling all Queries raised by FDA

Post-Approval

Renewal
Variation
Pack Size change
Additional Pack Size
Site transfer
Flavor Change
Presentation Change

Highlights of our services

We provide Dossier Templates which increases the chances of Dossier approval.
Compiling
Review
Preparation of the Dossier by using the customer’s data, as per respective FDA requirements.

Facility Design Services

We provide the following plant design services:

Design
- Formulation Facilities
  - Sterile Preparations
  - Solid Orals
  - Liquid Orals
  - External Preparation
- Laboratory
  - Wet Lab
  - Instrumental Lab
  - Microbiology Lab
  - Animal House
- In Detail Support
  - Unidirectional flow as per cGMP
  - Material, Personal & Process Flow
  - Identifying of Machine, equipments
  - Panel , HVAC , Utilities, Effluent
  - Epoxy / EPU Flooring, BMS
  - Commissioning
- Design Highlights
  - Facility Cost Reduction
  - Operational Cost Reduction
  - Compact Machines
  - Less area more usage
  - PAT, Risk / Quality Management
  - Automation system
Execution
- WE SUPPORT FOR PLANT EXECUTION
Turnkey
- WE TAKE UP TRUNKEY PROJECTS (From Ground Level to Business Level)
Guidance for Validation & Technology Transfer
- Facility, Equipment Qualification & Validation
- Process, Method Validation
- Stability Studies
- API, Formulation Tech Transfer
- Support for BE / BA Studies
Document & Other Supports
- URS , SOPs, STPs, DMFs, Dossiers, ACTD, CTD, eCTD
- BE / BE Studies, PSUR Reports Preparation, Risk Management Plan
- Technical Support to Run the facility
- Third Party Audits
- Finding Contract Manufactures, Technical Staff
- P2P Business Tie-ups
- FR&D, AR&D
- Regulatory Training & Consultancy Services
- Modulate factories as per the latest cGMP

REGULATORY AFFAIRS

EXPORTS

PLANT DESIGN SERVICES

ABOUT US

VISION

MISSION

PRODUCTS LIST

Oncology Orals

Oncology Injections

Powder Injections

Tablets Dry Powder Suspensions

Special New Products

SERVICES

Regulatory Services

eCTD Publishing and submission services

Regulatory Training & Guidance Services

Facility Design Services

Technology Transfer

Software Services

Call us on Skype!

For Regulatory Affairs

CONTACT

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