NAME OF THE MEDICINAL PRODUCT
Temozolomide capsules 5mg Taj Pharma
Temozolomide capsules 20mg Taj Pharma
Temozolomide capsules 100mg Taj Pharma
Temozolomide capsules 140mg Taj Pharma
Temozolomide capsules 180mg Taj Pharma
Temozolomide capsules 250mg Taj Pharma
- QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each hard capsule contains
Temozolomide USP 5mg
Excipient q.s
Colours: Approved Colours used in capsule shells
b) Each hard capsule contains
Temozolomide USP 20mg
Excipient q.s
Colours: Approved Colours used in capsule shells
c) Each hard capsule contains
Temozolomide USP 100mg
Excipient q.s
Colours: Approved Colours used in capsule shells
d) Each hard capsule contains
Temozolomide USP 140mg
Excipient q.s
Colours: Approved Colours used in capsule shells
e) Each hard capsule contains
Temozolomide USP 180mg
Excipient q.s
Colours: Approved Colours used in capsule shells
f) Each hard capsule contains
Temozolomide USP 250mg
Excipient q.s
Colours: Approved Colours used in capsule shells
- PHARMACEUTICAL FORM
Hard gelatin capsules.
- CLINICAL PARTICULARS
4.1 Therapeutic indications
Temozolomide capsules is indicated for the treatment of:
– adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
– children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temozolomide Capsules USP 20mg manufacturers in India {Taj Pharmaceuticals}; best quality suppliers and exporter of Temozolomide Capsules USP 20mg
Taj Pharmaceuticals manufactures a wide range of pharmaceuticals formulation involving Tablets / Capsules / Injections and Orals. Taj Pharma India team has an excellent expertise in manufacturing and export of Temozolomide Capsules USP 20mg. Taj Pharmaceuticals places its main business as a Pharmaceuticals manufacturing and exports of generic drug supply of Temozolomide Capsules USP 20mg; primarily of pharmaceuticals preparations known as Temozolomide Capsules USP 20mg; as well as more than 100+ generic equivalent drug. Taj Pharmaceuticals has performed these business activities related to exports of Temozolomide Capsules USP 20mg for major foreign-affiliated pharmaceutical import companies, ministry of health, tenders etc. and have enjoyed the full confidence of these companies, instructions and governments.
Taj Pharma Group Under close cooperation between the formulation manufacturing division, active ingredient division and the technology development division for major generic formulations such as Temozolomide Capsules USP 20mg; at Taj Pharma we will appropriately meet diverse needs for Temozolomide Capsules USP 20mg export manufacturing in a wide range of activities from investigation of possible formulations of Temozolomide Capsules USP 20mg, formulation development, making applications to the international regulatory authorities for marketing approval, validation of Temozolomide Capsules USP 20mg through to manufacturing scale production at our cGMP compliant manufacturing units of Taj Pharmaceuticals under the umbrella of Taj Pharma Group.
We at Taj Pharma intend to make our manufacturing systems comply with the requirements of the FDA (cGMP) such that pilot plant scale production of products in the stage of clinical development or for use in clinical studies, as well as manufacture of products in small lots are practicable to ensure a highly stable pharmaceuticals formulations of generic equivalent and bio-similar products. We conduct extensive bio-similar and bio-equivalency studies for all our formations in order to obtain better shelf life, absorption and excellent quality of our generic formulation.
Taj Pharmaceuticals LICENCES & CERTIFICATES for Temozolomide Capsules USP 20mg
- WHO-cGMP Certified
Taj Pharmaceuticals is manufactures Temozolomide Capsules USP 20mg under WHO-cGMP Plant. Taj Pharma is licenced to manufacture Temozolomide Capsules USP 20mg formulation from Food and Drug Administration of Indian authorities as the rules and regulations with all compliances for international markets. - ISO 9001: 201
All infrastructure of Taj Pharmaceuticals is ISO 9001:201 compliant and Taj Pharma team adheres to the specifies requirements for a quality management system in order to achieve : 1) To demonstrate our ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and. 2) Taj Pharma aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All manufacturing units of Taj Pharmaceutical follows the requirements of ISO 9001:201; which are generic under our standard operating procedure (SOP) and we intend such SOPs to be applicable to all manufacturing units, regardless of its type or size, or the products and services we provide.
- DUN & BRADSTREET (DUN’S NO.7206112)
Taj Pharma is recognised by Dun & Bradstreet; it is a corporation that offers information on commercial credit as well as reports on businesses with Data Universal Numbering System (DUNS numbers.
Third Party / Private Label / Customised Manufacturing
Taj Pharma has excellent infrastructure and drug manufacturing technology to offer private label / third party brands and generics as well; Taj Pharma team invites you to approachus for providing you an option for your products giving your customized requirement from product name to formula; also in international packing and manufacturing standards with all regulatory document needs.
We are exporting our Temozolomide Capsules USP 20mg product in Following Countries:-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin,Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand,Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Want to get your products Manufactured by Taj Pharma?
We at Taj Pharmaceuticals would be happy to help you. Just send your details below and we will take care of everything. (Please don’t post job queries here)
Taj Pharma As A Health Care Provider We put the customer at the front of every decision we make.
Taj Pharma India’s business can be contacted by common group e-mail: tajgroup@tajpharma.com, and query — will be forwarded to the relevant departments; additionally, telephone lines, ” Please Call TAJ PHARMA’s 24X7 helpline number i.e. 1800 222 434 (toll-free), 1800 222 825 (toll-free) Toll free numbers are accessible from all landlines and mobile phones in the country.” can be utilised if -you have an enquiry about the company, our healthcare business, or one of our medicines at India Standard Time (IST).
Direct line: +91 8448 444 095
Toll free: 1-800-222-434
Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592
+91 22 2637 4593
Fax No.:+91 22 2634 1274
E-Mail: info ( @ ) tajpharma dot com
