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Carmustine 100mg Injection | Generics | Oncology Product Taj Oncology Group India Carmustine 100mg Injection manufacturer in India

Carmustine
100mg Injection

Carmustine for Injection. Each package includes a vial containing 100 mg carmustine and an ampule containing 3 mL sterile diluent.

Carmustine is available in 100-mg single dose vials of lyophilized material. Sterile diluent for constitution of Carmustine is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in an ampule containing 3 mL of Dehydrated Alcohol Injection, USP.

STORAGE

Store in a refrigerator (2°-8°C, 36°-46°F).
Store diluent at controlled room temperature (15°-30°C, 59°-86°F) or in a refrigerator (2°-8°C, 36°-46°F).

Important Note

The lyophilized dosage formulation contains no preservatives and is not intended for use as a multiple dose vial.

Stability

The unopened vial of the dry drug must be stored in a refrigerator (2°-8°C, 36°-46°F). The diluent ampules may be stored at controlled room temperature (15°-30°C, 59°-86°F) or in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened Carmustine vials provides a stable product for up to 3 years. After reconstitution as recommended, Carmustine is stable for 24 hours under refrigeration (2°-8°C, 36°-46°F). Reconstituted vials should be examined for crystal formation prior to use. If crystals are observed, they may be redissolved by warming the vial to room temperature with agitation.

Vials reconstituted as directed and further diluted to a concentration of 0.2 mg/mL in 5% Dextrose Injection, USP, should be stored at room temperature, protected from light and utilized within 8 hours.

Glass containers were used for the stability data provided in this section. Only use glass containers for Carmustine administration.

Important Note

Carmustine has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The Carmustine will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the Carmustine is suitable for use and should be refrigerated immediately.

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The Bombay High Court in Sudhir Singh and Another vs. State of Maharashtra and Another, has rejected the anticipatory bail applications of directors of Taj Pharmaceuticals, for the offence of cheating, forgery punishable under IPC, selling or providing goods and services with a false trademark punishable .Emcure had approached IDMA IPR committee seeking assistance to take action against Taj Pharma for selling counterfeit version of cancer and brain tumour drug Carmustine in global market thereby jeopardizing public health, informed Dr Gopakumar Nair, chairperson of IDMA IPR committee. Emcure ...

Bomaby High Court denies promoters of Mumbai-based Taj Pharmaceuticals Limited anticipatory bail

DIVYA RAJAGOPAL

, ET Bureau|

Updated: Dec 05, 2016, 01.43 AM IST

MUMBAI: The Bombay High Court has denied promoters of Mumbai-based Taj Pharmaceuticals Limited anticipatory bail following allegations by rival Emcure Pharmaceuticals that Taj Pharmaceuticals was selling spurious versions of anti-cancer injectable drug brand Bicnu (carmustine).

"Justice Nitin Sambre rejected the anticipatory bail petition on the grounds of bringing disrepute to Indian pharma industry," said Hitesh Jain of law firm ALMT, which is representing Emcure Pharma.

This rejection means the court paved the way for the arrest of the promoters of Taj Pharma, Sudhir and Priyanka Singh, for selling and exporting spurious drugs, Jain told ET.

Taj Pharma executives, however, said the company has not yet heard of any decision.

"As objection, people keep postponing the debate on the plea," said an executive, who did not wish to be identified. Pune-based Emcure Pharma had in March filed a trademark infringement case against Taj Pharma charging its

its brand Bicnu was counterfeited.

The issue was subsequently resolved as the court ordered Taj Pharma to remove the stock that it was selling.

However, Taj Pharma maintained in its defence that it was not selling the injections under the Bicnu brand and contended that its marketed injection was sold under its own brand name Carmuther, manufactured by Hyderabad-based Theodore Pharma.

The company said it possessed all required marketing rights for selling and exporting this injection. Theodore Pharma did not respond to ET’s queries on its arrangement to supply the drug to Taj Pharma.

HC Disposed 'Copycat Drug' Claims and all Accusations Dropped Between Emcure Pharmaceuticals and Taj Pharmaceuticals

MUMBAI, April 26,2016/PRNewswire/ -

All Allegations of 'Spurious Drugs' Disposed Between the two Pharma Companies as Sales of Licensed Bio-Similar Found

After a heated few weeks at Taj Pharmaceuticals Ltd. and raised questions related to Counterfeit Carmustine 100mg Injections; all the allegations have been dropped by Emcure Pharmaceuticals for their brand misuses. The Hon'ble High Court, Justice Gautam Patel during hearing from both companies, guided the difference between generic and brands on medicines to the present counsels. After a considerable amount of evidence filed by both companies, it was concluded that, the counterfeit allegations were mislead by an Israeli firm Raz Pharmaceuticals to trigger Emcure for this suit; creating an immense concern to judiciary system and both parties involved in the Carmustine Injections business. However, after it was identified that in-fact Taj Pharmaceuticals supplies a generic version of the same drug through its licensed associate Therdose Pharma Pvt. Ltd, the confusion related to sales of 'spurious, illicit drugs' was cleared and no such claims stood relevant after Taj Pharmaceuticals' reply, and after licenses were presented for this matter. After the reply by Taj Pharma; it was observed that; both companies were engaged with supply of same active ingredient 'carmustine' in the injection; which is used in the treatment of patients diagnosed with cancer, lymphoma and tumors.

(Photo: http://photos.prnewswire.com/prnh/20160426/10144860 )

Senior counsel Dinyar Madon represented Taj Pharma; he outlined issues related to US FDA failures of Emcure Pharmaceuticals in March 2016, as a possible motive behind claims. However, setting aside all contentions, both companies agreed to protect intellectual property in question, follow FDA norms and disposed-off the matter since public health has been at question and a great deal of controversy between both the companies are related to this matter; as the companies were dealing with the same injection with main active ingredient 'carmustine'. Hon'ble High Court Justice Gautam Patel has clearly said in the judgment "There has been in the past great deal of controversy between the Emcure and Taj Pharma. I cannot within the frame of a civil suit address the grievances."

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About Taj Pharma Group

Taj Pharma Group is one of the leading generic pharmaceutical company in India. We hold top positions in different established markets and are building a strong presence in many emerging generics markets. Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products.

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