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Olanzapine (Form 1)

Olanzapine (Form 1) API

Olanzapine (Form 1)-API

CAS Number: 132539-06-1

Therapeutic Category
Bipolar-Disorder
Anti-Schizophrenic
Central Nervous System (CNS)
API Technology
Synthetic
Dose Form
Oral Solids
Injectable
Dr Reddy's Development Status
Available
Available Regulatory Filing
Canada
CEP
Europe
Australia
New Zealand
Innovator Brand (USA)
ZYPREXA

Mechanism of Action

The mechanism of action of olanzapine, as with other drugs having efficacy in schizophrenia, is unknown.

However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of olanzapine in the treatment of acute manic or mixed episodes associated with bipolar I disorder is unknown.

Indication

ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:

As oral formulation for the:

  • Treatment of schizophrenia.
  • Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial.
  • Adolescents (ages 13-17): Efficacy was established in one 6- week trial in patients with schizophrenia. The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. 
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.
  • Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial
  • Adolescents (ages 13-17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder. The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents.
  • Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks.
  • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder.
  • Efficacy was established in two 6-week clinical trials in adults. Maintenance efficacy has not been systematically evaluated.

As ZYPREXA IntraMuscular for the:

  • Treatment of acute agitation associated with schizophrenia and bipolar I mania.
  • Efficacy was established in three 1-day trials in adults.

As ZYPREXA and Fluoxetine in Combination for the:

  • Treatment of depressive episodes associated with bipolar I disorder.
  • Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.
  • Treatment of treatment resistant depression.
  • Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Olanzapine (Form 1) API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Olanzapine (Form 1) API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.