GENERICS
ONCOLOGY
Anastrozole
Anastrozole is a drug to treat breast cancer after surgery and for metastases in women both pre and postmenopausal. Anastrozole is an aromatase inhibitor, which means that interrupts a critical step in the synthesis of estrogens in the body. Some breast cancers require estrogen to grow, these cancers have receptors of estrogen (REs), and are called RE- positives. Their growth is suppressed eliminating estrogen.
Presentation: Tablets
Dose: 1 mg
Dossier: Available
MA: Granted and available
Supply: Available
Tech transfer: Available
Docetaxel
Docetaxel is a chemotherapeutic antimitotic clinical drug that works by interfering with the multiplication of cells. It is used for the treatment of locally advanced or metastatic breast cancer, head and neck cancer, stomach cancer, prostate cancer and some lung cancers. It can be used as a single agent or in combination with other chemotherapeutic medication depending on the type of cancer and the stage.
Presentation: Concentrate for solution for injection
Dose: 20/80/160 mg (20 mg/ml)
Dossier: Available
MA: Granted and available
Supply: Available
Tech transfer: Not available
Letrozole
Letrozole is a drug that belongs to the group of aromatase inhibitors and it is used in the treatment of hormonally-responsive breast cancer after surgery.
Presentation: Tablets
Dose: 2.5 mg
Dossier: Available
MA: Granted, not available
Supply: Not Available
Tech transfer: Available
Oxaliplatin
Oxaliplatin is a chemical compound that is used as an antineoplastic drug, i.e. it acts against the development of cancer cells.
Presentation: Concentrate for solution for injection
Dose: 50/100/200 mg (5 mg/ml)
Dossier: Available
MA: Granted, not available
Supply: Available
Tech transfer: Not available
ANTIBIOTICS
Clarithromycin
Clarithromycin is the name of an antibiotic belonging to macrolides group which is indicated for the treatment of infections of the skin, breast and the respiratory tract, including pharyngitis, tonsillitis, sinusitis, chronic bronchitis, bacterial pneumonia – in particular those caused by the bacteria Chlamydia pneumoniae – and in patients with HIV to prevent and treat infections by the complex Mycobacterium avium. Occasionally indicated for the treatment of legionellosis.
Presentation: Lyophilized for injection
Dose: 500 mg/vial
Dossier: Available
MA: Granted, not available
Supply: Not available
Tech transfer: Available
CARDIOVASCULAR
Atorvastatin
Atorvastatin is a drug from the statin family used to lower blood cholesterol levels and in the prevention of cardiovascular diseases. It also stabilizes the plaques and prevents embolism through anti-inflammatory mechanisms.
Presentation: Tablets
Dose: 10/20/40 mg
Dossier: Available
MA: Granted, not available
Supply: Not available
Tech transfer: Available
Irebesartan
Irbesartan is a drug used in the treatment of hypertension. Exerts its action on blood pressure as the enzyme Angiotensin II receptor antagonist, is a non-peptide antagonist with long-lasting effects.
Presentation: Tablets
Dose: 75/150/300 mg
Dossier: Available
MA: Granted, not available
Supply: Not available
Tech transfer: Available
Irbesartan + Hydrochlorothiazide
Irbesartan is a drug used in the treatment of hypertension. Exerts its action on blood pressure as the enzyme Angiotensin II receptor antagonist, is a non-peptide antagonist with long-lasting effects.
Hydrochlorothiazide is a diuretic drug of first choice belonging to the group of thiazides. It works by inhibiting sodium/chlorine co-transporters in the distal contoured tubule of the kidney to retain water, causing an increase of urine. This reduces the volume of the blood, decreasing its return to the heart and thus the cardiac output. In addition, by other mechanisms, it is believed to lower peripheral vascular resistance.
Presentation: Tablets
Dose: 150mg+12.5mg / 300mg+12.5mg
Dossier: Available
MA: Granted, not available
Supply: Not available
Tech transfer: Available
Rivaroxaban
Rivaroxaban is an oral anticoagulant used to treat and prevent blood clots. It acts by inhibiting the active form of the coagulation factor X (factor Xa). Specifically, it is used to treat deep vein thrombosis and pulmonary embolism and prevent blood clots in atrial fibrillation and after hip or knee surgery.
Presentation: Tablets
Dose: 10/15/20 mg
Dossier: In development
MA: Pending
Supply: Not available
Tech transfer: Not available
Telmisartan
Telmisartan, is a non-peptide antihypertensive drug AIIRA type (angiotensin II receptor antagonist), indicated for the treatment of hypertension. The antihypertensive effects start within the first 3 hours of the administration of the medication.
Presentation: Tablets
Dose: 20/40/80 mg
Dossier: Available
MA: Granted and available
Supply: Not available
Tech transfer: Available
CNS
Quetiapine
Quetiapine is a neuroleptic drug belonging to the antipsychotic group, used in the treatment of schizophrenia and severe manic and depressive episodes of bipolar disorder. Quetiapine is a serotonin (5-HT)1A and (5-HT)2A receptor antagonist, dopamine D1 and D2 receptor antagonist, H1 histamine receptor antagonist and α1 and α2 adrenergic receptor antagonist.
Quetiapine IR (Immediate Release)
Presentation: Tablets
Dose: 25/50/100/150/200/300/400 mg
Dossier: Available
MA: Granted, not available
Supply: Not available
Tech transfer: Available
Quetiapine SR (Slow Release)
Presentation: Tablets
Dose: 50/150/200/300/400 mg
Dossier: Available
MA: Granted, not available
Supply: Not available
Tech transfer: Available
Rivastigmine
Rivastigmine is a cholinergic, acetylcholinesterase inhibitor drug, so it increases the levels of the neurotransmitter acetylcholine in various brain regions. It may be beneficial in the cognitive deficits in Alzheimer’s disease in which the cholinergic system is mediating (and) for the treatment of dementia linked with Parkinson’s disease.
Presentation: Capsules and Oral Solution
Dose: 1.5/3/4.5/6 mg & 2mg/ml
Dossier: Available
MA: Granted and available
Supply: Available
Tech transfer: Available
GASTROENTERAL
Pantoprazole
The pantoprazole is an inhibitor of the Proton pump in the stomach that is used in the short-term treatment of erosions and ulcers caused by gastroesophageal reflux disease. It is also indicated for the treatment of diseases in which the body produces an excess of acid stomach, as in Zollinger-Ellison syndrome.
Presentation: Lyophilized for injection
Dose: 40 mg/vial
Dossier: Available
MA: Granted and available
Supply: Not available
Tech transfer: Available
PAIN
Paracetamol + Tramadol
Paracetamol is a drug with analgesic and antipyretic properties. Tramadol is an opioid-type pain medication that relieves pain by acting on specific nerve cells in the spinal cord and brain. The combination of paracetamol with tramadol is used to reduce severe pain, such as cancer pain or after surgery.
Presentation: Tablets
Dose: 325 + 37.5 mg
Dossier: Available
MA: Granted, not available
Supply: Not available
Tech transfer: Available