Accueil CDMO Shilpa Medicare Limited
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Shilpa Medicare Limited

Profil géré par Bizz Id
Inde 500+ 1987
CDMO IPA
Réclamer ce profil

Description

Cotée au NSE et à l'ESB, fondée en 1987, avec une production commerciale commençant à Raichur en 1989. Elle gère cinq usines, dont deux unités à Raichur, une à Jadcherla et une à Dabaspet, ainsi qu'un centre de recherche biologique à Hubli. Il déclare des capacités dans les domaines des ingrédients actifs de haute puissance, de l'oncologie, des peptides et de la chimie en flux continu.

Produits

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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