Accord

Mycophenolate Mofetil Powder Approved in Europe

Accord’s Mycophenolate Mofetil Powder for concentrate for solution for infusion has been approved through DCP for the European market. The Product will be available in 500 mg strength in packs of 1 or 4 vials. Mycophenolate Mofetil Powder was firstly commercialised by Roche under the brand Cellcept® .By obtaining this approval, Accord becomes the first company to secure generic Mycophenolate Mofetil injectable approval.

Mycophenolate Mofetil Powder in combination with ciclosporin and corticosteroids is indicated for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal or hepatic transplants.

Paricalcitol Inj. Approved in Europe

Accord’s Paricalcitol Solution for injection has been approved through DCP for the European market. The Product will be available in presentations of 2mcg/1ml and 10mcg/2ml in packs of 1 or 5 vials. Paricalcitol was firstly commercialized by AbbVie under the brand Zemplar®.

Paricalcitol is indicated for the prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing hemodialysis.

Mitoxantrone Inj. Approved in Europe

Accord’s Mitoxantrone concentrate for solution for infusion has been approved through DCP for the European market. The Product will be available in presentations of 10, 20 and 30 mg.

Mitoxantrone was firstly commercialized by Meda under the brand Novantrone®.

Mitoxantrone Accord is indicated for the treatment of:

- Metastatic breast cancer, non-Hodgkin’s lymphoma and acute non-lymphocytic leukaemia in adults, alone or in combination with other antineoplastic agents.
- Pain as a result of an advanced hormone-refractory prostate cancer in combination with a low dose of corticosteroids if the standard treatment with analgesics is inadequate or inappropriate.

Docetaxel inj. Approved in Australia

Docetaxel Concentrate for injection has been registered and approved in Australia and will be launched shortly. It has been registered in four strengths i.e. 20mg/1mL, 80mg/4mL and 160mg/8mL. Docetaxel injection is a chemotherapeutic agent, indicated for treatment of various cancers like Breast Cancer, Non small cell lung Cancer, Ovarian Cancer, Prostate Cancer & Head and Neck Cancer.

Pemetrexed Inj. Approved in Brazil

Pemetrexed Injection (LYOPHILIZED) has been registered in BRAZIL with “The National Health Surveillance Agency (ANVISA)” and will be launched shortly. It has been registered in two strengths i.e. 100mg/vial & 500mg/vial in generic category. Pemetrexed Injection is an chemotherapeutic agent, indicated for treatment of various cancers like pleural mesothelioma and non-small cell lung cancer.

Docetaxel RTU(Ready to Use) Inj. approved in Mexico

Docetaxel RTU Injection has been registered in MEXICO and will be launched shortly under the brand name of TAXANIT RTU. TAXANIT RTU has been registered in three strengths i.e. 20mg/ml, 80mg/4ml & 160mg/8ml. Docetaxel is a chemotherapeutic agent indicated for the treatment of Breast cancer, colorectal cancer etc.

Oxaliplatin RTU (Ready To Use) Inj. approved in Mexico

Oxaliplatin RTU Injection has been registered in MEXICO and will be launched under the brand name of RECOPLAT RTU. RECOPLAT RTU has been registered in three strengths i.e. 50 mg/ 10 ml, 100 mg/ 20 ml & 200 mg/40ml. Oxaliplatin is a chemotherapeutic agent indicated for the treatment of metastatic colorectal cancer.

Metotrexato Inj. approved in Mexico

Metotrexato injection has been registered in MEXICO and will be launched shortly under the brand name of TRAXACORD. TRAXACORD has been registered in three strength i.e. 50mg/2ml, 500mg/5ml, 1g/10ml. Metotrexato a chemotherapeutic agent and is indicated in the treatment of neoplastic disease, such as trophoblastic neoplasms and leukemia

Montelukast Tablet approved in Mexico

Montelukast 10 mg Tablet has been registered in MEXICO and will be launched shortly under the brand Name of SINBRUX. Montelukast is indicated in the treatment of asthma. It can also provide symptomatic relief in seasonal allergic rhinitis.

Palonosetron Inj. approved in Mexico

Palonosetron injection has been registered in MEXICO and it will be launched shortly under the brand name of VIQET. VIQET has been registered in single strength i.e. 0.25 mg/5ml.

Palonosetron is indicated in the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy.

Ibandronato Inj. approved in Mexico

Ibandronato injection has been registered in MEXICO and it will be launched shortly under the brand name of EUTROBON. EUTROBON has been registered in single strength i.e. 2mg/2ml . Ibandronato is indicated in the treatment of osteoporosis in postmenopausal women.

Bortezomib Inj. Approved in Brazil

Bortezomib Injection has been registered in BRAZIL with “The National Health Surveillance Agency (ANVISA)” and will be launched shortly. It has been registered in single strength i.e. 3.5mg/vial in generic category. Bortezomib Injection is an chemotherapeutic agent, indicated for treatment of various cancers like Multiple Myeloma & Mantle Cell lymphoma.”

Memantine film-coated tablets approved in entire European Union

The successful closure of the centralized application for Memantine; the product has been registered through the entire EU. Memantine Accord 5 mg, 10 mg, 15 mg, 20 mg film coated tablets will be launched shortly.

Memantine Accord film coated tablets is indicated for the treatment of patients with moderate to severe Alzheimer's disease. Memantine Accord is the generic version of Ebixa® (Lundbeck).

Capecitabine Tablets Approved in entire European Union

Accord’s Capecitabine tablet (generic version of Xeloda®) has been registered in entire European Union countries through centralized registration procedure and will be launched shortly.

Capecitabine Accord Tablet will be available 150mg, 300mg & 500 mg in 30’s, 60’s & 120’s pack. Capecitabine Accord Tablet is an orally administered chemotherapeutic agent, indicated for the treatment of various cancers like colorectal, Breast, Colon, Rectum, Stomach, Pancreas & Esophagus.

The current market of Capecitabine tablets in Europe is valued around USD 392.5 Million (IMS Health-Dec, 2012).

Cytarabine 100 mg/ ml solution for injection Approved in Europe

Accord’s Cytarabine 100 mg/ ml solution for injection has been approved through MRP in Europe. Cytarabine Accord is available in presentations of 100 mg, 500 mg, 1000mg and 5000 mg. Cytarabine Injection is used in the treatment of acute myeloid leukemia in adults and for other acute leukemia of adults and children.

Ramipril Tablet Approved in Europe

Accord’s Ramipril Tablets has been approved through DCP for the European market. Presentations approved include 1.25 mg, 2.5 mg, 5 mg and 10 mg. Ramipril is indicated to treat high blood pressure (hypertension); reduce the risks of having a heart attack or stroke; reduces the risk or delays the worsening of kidney problems; to treat heart failure and as treatment following heart attack (myocardial infarction) complicated with heart failure.

Voriconazole film- coated tablet approved in Europe

Voriconazole film- coated tablet has been approved through centralized registration procedure in entire European Union. Voriconazole Accord is available in presentations of 50 mg and 200 mg film-coated tablets and it is indicated for the treatment of invasive aspergillosis; treatment of candidemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.

Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.

Sumatriptan 50/100mg Tablets has obtained approval in Europe

The approval of Sumatriptan Accord 50/100mg tablets through MRP in Europe. Sumatriptan tablets are indicated for the acute treatment of migraine attacks, with or without aura. Sumatriptan should only be used where there is a clear diagnosis of migraine. Sumatriptan Accord is the generic version of Imitrex® from GSK.

Quetiapine 50mg prolonged release tablets approved in Europe

Accord has completed the registration procedure & subsequentlyreceived the approval of the 50mg presentation of Quetiapine Accord 50mg prolonged release tablets.

Imatinib Tablets approved in Europe

Accord is highly pleased to announce the completion of the centralized procedure of Imatinib tablets. The product has been registered through the entire European Union. Imatinib Accord is the generic version of the branded product Glivec® from Novartis and is indicated for the treatment of different leukaemia in adults and paediatric patients. The product will be available in presentations of 100mg and 400mg film- coated tablets, in different pack sizes of 10, 20, 30, 60, 90, 120 and 180 tablets.