Início CDMO Shilpa Medicare Limited
S

Shilpa Medicare Limited

Perfil gerido pelo Bizz Id
Índia 500+ 1987
CDMO IFAs
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Descrição

Listada na NSE e na BSE, fundada em 1987, com produção comercial iniciada em Raichur em 1989. Opera cinco fábricas, incluindo duas unidades em Raichur, uma em Jadcherla e uma em Dabaspet, além de um centro de investigação biológica em Hubli. Declara capacidade em ingredientes ativos de alta potência, oncologia, peptídeos e química de fluxo contínuo.

Produtos

Abemaciclib

Oncology API. Tech pack available (no filing submitted).

Abemaciclib Tablets 50mg, 100mg, 150mg, 200mg

Finished product - oncology oral solid under development.

Abiraterone Acetate

Oncology API. Filings submitted: USDMF, ASMF (EU).

Abiraterone Acetate 250mg, 500mg, 1000mg

Finished product - oncology oral solid. Dossier available.

Desmopressin Acetate

Peptide API. Filings submitted: CEP, USDMF. CAS 62288-83-9.

Octreotide Acetate

Peptide API. Filings submitted: CEP, USDMF. CAS 79517-01-4.

Sermorelin Acetate

Peptide API. Tech pack available (no filing submitted). CAS 86168-78-7.

Alectinib 150mg

Finished product - oncology oral solid under development.

Amifampridine Tablets 10mg

Finished product - non-oncology oral solid. Dossier available.

Anastrozole

Oncology API. Filings submitted: USDMF, JDMF.

Angiotensin II

Peptide API. Tech pack available (no filing submitted). CAS 4474-91-3.

Apalutamide

Oncology API. Tech pack available (no filing submitted).

Apalutamide Tablets 60mg, 240mg

Finished product - oncology oral solid under development.

Apixaban 1mg/ml (150ml)

Finished product - oral suspension under development.

Apremilast Tablets 10mg, 20mg & 30mg

Finished product - non-oncology oral solid. Dossier available.

Avibactam Sodium

Non-oncology API under development.

Axitinib

Oncology API. Filings submitted: USDMF, ASMF (EMEA).

Axitinib Tablets 1mg, 3mg, 5mg & 7mg

Finished product - oncology oral solid. Dossier available.

Azacitidine

Oncology API. Filings submitted: USDMF, ASMF (EU), JDMF.

Azacitidine tablets 200mg and 300mg

Finished product - oncology oral solid. Dossier available.

Azacitidine injection 25mg/ml - 100mg vial

Finished product - oncology injectable. Dossier available.

Bacillus Coagulans 5 Billion CFU (Probiotic)

Finished product - nutraceutical oral dispersible film. Dossier available.

Bendamustine for injection 25mg/ml - 100mg vial

Finished product - oncology injectable. Dossier available.

Bicalutamide

Oncology API. Filings submitted: USDMF, ASMF.

Bilastine 10mg, 20mg

Finished product - oral dispersible film. Dossier available.

Biotin 5000 IU

Finished product - nutraceutical oral dispersible film. Dossier available.

Bortezomib

Oncology API. Filings submitted: USDMF, ASMF (EMEA).

Bortezomib (BZX)

Oncology API. Filings submitted: USDMF, ASMF (EMEA).

Bortezomib Injection 3.5mg/1.4ml

Finished product - oncology injectable. Dossier available.

Bortezomib for Injection 3.5mg

Finished product - oncology injectable. Dossier available.

Glycopyrronium Bromide

Non-oncology API. Filings submitted: CEP.

Busulfan

Oncology API. Filings submitted: USDMF, CEP, JDMF.

Busulfan 6mg/ml

Finished product - oncology injectable. Dossier available.

Cabazitaxel

Oncology API. Filings submitted: USDMF, ASMF (EU).

Cabazitaxel Injection 10mg/mL

Finished product - oncology injectable under development.

Cabozantinib Tablets 20mg, 40mg, 60mg

Finished product - oncology oral solid under development.

Caffeine 50mg

Finished product - nutraceutical oral dispersible film. Dossier available.

Caffeine 50mg + L-Theanine 15mg + Methylcobalamin 1000mcg

Finished product - nutraceutical oral dispersible film. Dossier available.

Capecitabine

Oncology API. Filings submitted: USDMF, CEP, JDMF.

Capecitabine 200mg/ml

Finished product - oncology oral suspension. Dossier available.

Capecitabine Tablets 1000mg

Finished product - oncology oral solid. Dossier available.

Capecitabine Tablets 150mg & 500mg

Finished product - oncology oral solid. Dossier available.

Carboplatin

Oncology API. Tech pack available (no filing submitted).

Carfilzomib for Injection 10mg, 30mg, 60mg

Finished product - oncology injectable under development.

Cyclophosphamide

Oncology API. Filings submitted: USDMF, CEP.

Cyclophosphamide Capsules 25mg & 50mg

Finished product - oncology oral solid. Dossier available.

Cyclophosphamide Powder for Injection 500mg, 1gm & 2gm

Finished product - oncology injectable. Dossier available.

Cisplatin

Oncology API. Tech pack available (no filing submitted).

Revumenib Citrate hydrate

Oncology API under development.

Sildenafil Citrate 25mg, 50mg

Finished product - oral dispersible film. Dossier available.

Clevidipine Intravenous Injection 0.5mg/mL

Finished product - GLP-1, peptides and other injectables under development.

Clofarabine

Oncology API. Filings submitted: USDMF, ASMF.

Clofarabine Injection 20mg vial

Finished product - oncology injectable. Dossier available.

Acoramidis Hydrochloride

Non-oncology API. Tech pack available (no filing submitted).

Alectinib Hydrochloride

Oncology API. Tech pack available (no filing submitted).

Ambroxol HCl

Non-oncology API. Filings submitted: CEP, JDMF.

Bendamustine HCl Monohydrate

Oncology API. Filings submitted: USDMF, ASMF.

Erlotinib HCl

Oncology API. Filings submitted: USDMF, ASMF.

Phenylephrine HCl

Non-oncology API. Filings submitted: USDMF, CEP.

Fingolimod HCl

Non-oncology API. Filings submitted: USDMF, CEP.

Gemcitabine HCl

Oncology API. Filings submitted: USDMF, CEP, JDMF.

Gemcitabine HCl (Process 2)

Oncology API. Filings submitted: USDMF, CEP.

Irinotecan HCl Injection 20mg/ml

Finished product - oncology injectable. Dossier available.

Irinotecan HCl Trihydrate

Oncology API. Filings submitted: USDMF, CEP.

Melphalan HCl

Oncology API. Filings submitted: USDMF, ASMF.

Naloxone hydrochloride

Non-oncology API under development.

Nilotinib Hydrochloride

Oncology API. DMF available (no filing submitted).

Ondansetron Hydrochloride 2mg, 4mg, 8mg

Finished product - oral dispersible film. Dossier available.

Ruxolitinib Hydrochloride

Oncology API. DMF available (no filing submitted).

Ruxolitinib HCl 5mg, 10mg, 15mg and 20mg

Finished product - oncology oral solid. Dossier available.

Topotecan Hydrochloride

Oncology API. Tech pack available (no filing submitted).

Co-enzyme Q10 100mg

Finished product - nutraceutical oral dispersible film. Dossier available.

Crizotinib

Oncology API under development.

Darolutamide

Oncology API under development.

Dasatinib

Oncology API. Filings submitted: USDMF.

Dasatinib 40mg/ml

Finished product - oncology oral suspension. Dossier available.

Decitabine

Oncology API. Filings submitted: USDMF, ASMF (EU).

Desmopressin 60mcg, 120mcg, 240mcg

Finished product - non-oncology oral solid. Dossier available.

Diclofenac Diethylamine 100mg, 200mg

Finished product - transdermal patch. Dossier available.

Betahistine DiHCl 8mg, 16mg, 24mg

Finished product - oral dispersible film. Dossier available.

Dimethyl Fumarate

Non-oncology API. Filings submitted: USDMF.

Dimethyl Fumarate DR 120mg, 240mg

Finished product - non-oncology oral solid. Dossier available.

Docetaxel

Oncology API. Tech pack available (no filing submitted).

Docetaxel Injection 20mg/ml

Finished product - oncology injectable. Dossier available.

Docetaxel Injection 20mg/ml (Alcohol Free)

Finished product - oncology injectable. Dossier available.

Docetaxel Trihydrate

Oncology API. Tech pack available (no filing submitted).

Donepezil 5mg, 10mg/24hrs (Weekly Patch)

Finished product - transdermal patch under development.

Dutasteride Topical Solution 0.05%

Finished product - topical under development.

Eltrombopag Olamine

Non-oncology API. Filings submitted: USDMF.

Eltrombopag Olamine 25mg, 50mg and 75mg

Finished product - non-oncology oral solid. Dossier available.

Encorafenib

Oncology API. Tech pack available (no filing submitted).

Enzalutamide

Oncology API. Filings submitted: USDMF.

Enzalutamide tablets 40mg, 80mg and 160mg

Finished product - oncology oral solid. Dossier available.

Erlotinib tablets 25mg, 100mg & 150mg

Finished product - oncology oral solid. Dossier available.

Fingolimod 0.5mg

Finished product - non-oncology oral solid. Dossier available.

Amifampridine Phosphate

Non-oncology API. Filings submitted: ASMF.

Ruxolitinib Phosphate

Oncology API. DMF available (no filing submitted).

Ruxolitinib Phosphate 5mg, 10mg, 15mg and 20mg

Finished product - oncology oral solid. Dossier available.

Fosravuconazole

Non-oncology API under development.

Tenofovir Alafenamide Fumarate

Non-oncology API. Filings submitted: USDMF.

Gemcitabine Injection RTU 38mg/ml

Finished product - oncology injectable. Dossier available.

Iron 14mg

Finished product - nutraceutical oral dispersible film. Dossier available.

Ibrutinib

Oncology API. Filings submitted: USDMF.

Ibrutinib tablets 140mg, 280mg, 420mg and 560mg

Finished product - oncology oral solid under development.

Ibrutinib Capsules 140mg

Finished product - oncology oral solid. Dossier available.

Ifosfamide for Injection 1g, 2g, 3g

Finished product - oncology injectable under development.

Imatinib 80mg/ml

Finished product - oncology oral suspension. Dossier available.

Ketoprofen 30mg patch

Finished product - transdermal patch. Dossier available.

Lenalidomide

Oncology API. Filings submitted: USDMF, ASMF.

Lenalidomide 25mg/5ml

Finished product - oncology oral suspension. Dossier available.

Lenvatinib Capsules 4mg & 10mg

Finished product - oncology oral solid. Dossier available.

Letrozole

Oncology API. Filings submitted: USDMF, JDMF.

Liraglutide

GLP-1 peptide API. Filings submitted: USDMF. CAS 204656-20-2.

Liraglutide injection 6mg/ml

Finished product - GLP-1, peptides and other injectables. Dossier available.

Lorlatinib

Oncology API under development.

Loxoprofen Sodium

Non-oncology API. DMF available (no filing submitted).

Sunitinib Malate

Oncology API. Filings submitted: USDMF, ASMF (EU).

Acalabrutinib Maleate

Oncology API. Tech pack available (no filing submitted).

Sunitinib Maleate Capsules 12.5mg, 25mg, 37.5mg & 50mg

Finished product - oncology oral solid. Dossier available.

Melatonin 1.9mg + Vitamin D3 200IU + B6 700mcg + Folic acid 100mcg

Finished product - nutraceutical oral dispersible film. Dossier available.

Melatonin 3mg

Finished product - oral dispersible film. Dossier available.

Melphalan for injection 50mg vial

Finished product - oncology injectable. Dossier available.

Enasidenib mesylate

Oncology API under development.

Imatinib Mesylate

Oncology API. Filings submitted: USDMF, CEP.

Imatinib Mesylate (beta form)

Oncology API. Filings submitted: CEP.

Imatinib Mesylate 100mg, 400mg

Finished product - oncology oral solid. Dossier available.

Lenvatinib Mesylate

Oncology API. Filings submitted: USDMF, ASMF (EU).

Osimertinib mesylate

Oncology API under development.

Methylcobalamin 500mcg, 1000mcg, 1500mcg

Finished product - oral dispersible film. Dossier available.

Methotrexate Base

Oncology API. Filings submitted: USDMF, CEP.

Methotrexate Disodium

Oncology API. Filings submitted: USDMF.

Mycophenolate Mofetil

Non-oncology API. DMF available (no filing submitted).

Mycophenolate Sodium

Non-oncology API. Tech pack available (no filing submitted).

Montelukast Sodium

Non-oncology API. Filings submitted: CEP.

Nifedipine

Non-oncology API. Filings submitted: USDMF, CEP.

Nilotinib

Oncology API. Filings submitted: USDMF, ASMF (EU).

Nilotinib Tablets 50mg, 150mg & 200mg

Finished product - oncology oral solid. Dossier available.

Olaparib

Oncology API. DMF available (no filing submitted).

Olaparib 100mg and 150mg

Finished product - oncology oral solid. Dossier available.

Orforglipron Hemicalcium Hydrate

Non-oncology API. Tech pack available (no filing submitted).

Oxaliplatin

Oncology API. Filings submitted: USDMF, CEP.

Oxcarbazepine

Non-oncology API. Filings submitted: CEP.

Paclitaxel

Oncology API. Tech pack available (no filing submitted).

Paclitaxel Albumin Bound Particles for Injectable Suspension 100mg/vial

Finished product - oncology injectable. Dossier available.

Paclitaxel Injection 6mg/mL (5ml, 16.7ml & 50mL)

Finished product - oncology injectable. Dossier available.

Palbociclib

Oncology API. Filings submitted: USDMF, ASMF (EU).

Palbociclib 75mg, 100mg and 125mg

Finished product - oncology oral solid. Dossier available.

Paracetamol 60mg, 80mg & 120mg

Finished product - oral dispersible film. Dossier available.

Pemetrexed Dipotassium

Oncology API. Filings submitted: USDMF.

Pemetrexed Disodium

Oncology API. Filings submitted: USDMF, CEP.

Pemetrexed RTU 10mg/ml

Finished product - oncology injectable. Dossier available.

Pemetrexed for Injection 100mg/vial & 500mg/vial

Finished product - oncology injectable. Dossier available.

Pirfenidone

Non-oncology API. Filings submitted: USDMF, CEP.

Pirfenidone 267mg, 801mg

Finished product - non-oncology oral solid. Dossier available.

Pomalidomide

Oncology API. Filings submitted: USDMF, ASMF (EU), JDMF.

Pregabalin 25mg, 50mg, 75mg

Finished product - oral dispersible film. Dossier available.

Prucalopride 1mg, 2mg

Finished product - non-oncology oral solid. Dossier available.

Mouth Fresheners with different flavours

Finished product - nutraceutical oral dispersible film. Dossier available.

Relugolix

Oncology API under development.

Relugolix Tablets 120mg

Finished product - oncology oral solid under development.

Resmetirom

Non-oncology API under development.

Rivaroxaban 2.5mg, 10mg, 15mg, 20mg

Finished product - oral dispersible film. Dossier available.

Rivastigmine 4.6mg, 9.5mg, 13.3mg/24hours

Finished product - transdermal patch under development.

Rotigotine 1mg, 2mg, 3mg, 4mg, 6mg, 8mg/24hours

Finished product - transdermal patch. Dossier available.

Selexipag 200mcg/ml and 800mcg/ml

Finished product - oral suspension under development.

Semaglutide

GLP-1 peptide API. Tech pack available (no filing submitted). CAS 910463-68-2.

Semaglutide Tablets 1.5mg, 4mg and 9mg

Finished product - GLP-1, peptides and other injectables under development.

Semaglutide Injection 1.34mg/mL (0.25, 0.5, 1mg) and 2.68mg/mL (2.0mg)

Finished product - GLP-1, peptides and other injectables. Dossier available.

Semaglutide Injection 2.27mg/mL (1.7mg), 3.2mg/mL (2.4mg) and 0.68mg/mL (0.25, 0.5mg)

Finished product - GLP-1, peptides and other injectables. Dossier available.

Simethicone 62.5mg

Finished product - oral dispersible film. Dossier available.

Prucalopride Succinate

Non-oncology API. Filings submitted: USDMF, ASMF (EU).

Ribociclib succinate

Oncology API under development.

Sunitinib 50mg/5ml

Finished product - oncology oral suspension. Dossier available.

Tadalafil 5mg, 10mg, 20mg

Finished product - oral dispersible film. Dossier available.

Tafamidis

Non-oncology API under development.

Tafamidis 61mg

Finished product - non-oncology oral solid under development.

Thalidomide

Oncology API. Filings submitted: USDMF, ASMF (EU).

Thalidomide Capsules 50mg

Finished product - oncology oral solid. Dossier available.

Varenicline Tartrate

Non-oncology API. Filings submitted: USDMF, ASMF (EU).

Teduglutide

Peptide API. Tech pack available (no filing submitted). CAS 197922-42-2.

Temozolomide

Oncology API. Filings submitted: USDMF, CEP, JDMF.

Temozolomide Capsules 5mg, 20mg, 100mg, 140mg, 180mg & 250mg

Finished product - oncology oral solid. Dossier available.

Tenofovir Alafenamide 25mg

Finished product - non-oncology oral solid. Dossier available.

Teriflunomide

Non-oncology API. Filings submitted: USDMF, CEP.

Teriflunomide 14mg

Finished product - non-oncology oral solid. Dossier available.

Teriparatide

Peptide API. Tech pack available (no filing submitted). CAS 52232-67-4.

Teriparatide Injection 0.25mg/mL

Finished product - GLP-1, peptides and other injectables under development.

Tesamorelin

Peptide API. Tech pack available (no filing submitted). CAS 901758-09-6.

Tipepidine

Non-oncology API. Tech pack available (no filing submitted).

Tirzepatide

GLP-1 peptide API. Tech pack available (no filing submitted). CAS 2023788-19-2.

Tocopherol

Non-oncology API. Tech pack available (no filing submitted).

Tofacitinib ER Tablets 11mg

Finished product - non-oncology oral solid under development.

Sorafenib Tosilate

Oncology API. Filings submitted: CEP.

Treosulfan

Oncology API under development.

Instant Green Tea

Finished product - nutraceutical oral dispersible film. Dossier available.

Upadacitinib hemihydrate

Non-oncology API under development.

Vancomycin injection 500mg

Finished product - GLP-1, peptides and other injectables under development.

Varenicline 0.5mg, 1mg

Finished product - non-oncology oral solid. Dossier available.

Vasopressin injection 0.2IU, 0.4IU, 0.6IU

Finished product - GLP-1, peptides and other injectables under development.

Vismodegib

Oncology API. Tech pack available (no filing submitted).

Vismodegib Capsule 150mg

Finished product - oncology oral solid under development.

Vitamin D3 400 to 60k IU

Finished product - oral dispersible film. Dossier available.

Vitamin K2 70mcg + Vitamin D3 1000IU

Finished product - nutraceutical oral dispersible film. Dossier available.

Zanubrutinib

Oncology API under development.

Zanubrutinib Tablets 160mg

Finished product - oncology oral solid under development.

Cabozantinib s-malate

Oncology API under development.

NOR UDCA 500mg and 750mg

Finished product - non-oncology oral solid. Dossier available.

Tranexamic Acid

Non-oncology API. Filings submitted: USDMF, CEP.

Tranexamic Acid spray 10% (World's First Hemostatic Spray)

Finished product - topical. Dossier available.

UDCA Tablets 600mg

Finished product - non-oncology oral solid. Dossier available.

Ursodeoxycholic Acid / Ursodiol (chicken bile origin)

Non-oncology API. Filings submitted: USDMF, CEP, JDMF.

Ursodeoxycholic Acid / Ursodiol (bovine origin)

Non-oncology API. Filings submitted: USDMF.

Zoledronic Acid

Oncology API. Filings submitted: USDMF, CEP.

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