Methotrexate has been reported to cause fetal death and/or congenital anomalies.Therefore, it is not recommended for women of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant women with psoriasis or rheumatoid arthritis should not receive methotrexate.
Methotrexate Injection USP 250mg/10ml Taj Pharma
- NAME OF THE MEDICINAL PRODUCT
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Methotrexate 50mg/ 2ml Injection Taj Pharma
a) Each vial contains:
Sodium chloride 0.490% w/v
Hydrochloric acid may be used as pH adjuster
Methotrexate 250mg/ 10ml Injection Taj Pharma
b) Each vial contains:
Sodium chloride 0.490% w/v
Hydrochloric acid may be used as pH adjuster
Methotrexate 1000mg/ 10ml Injection Taj Pharma
c) Each vial contains:
Sodium chloride 0.490% w/v
Hydrochloric acid may be used as pH adjuster
For excipients, see 6.1.
- PHARMACEUTICAL FORM
Solution for Injection
Vials containing a clear yellow solution
- CLINICAL PARTICULARS
4.1 Therapeutic indications
Methotrexate is indicated in the treatment of neoplastic disease, such as trophoblastic neoplasms and leukaemia, and the symptomatic treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy.
We are exporting our Methotrexate Injection USP 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
Methotrexate Injection USP Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
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 Methotrexate Injection USP . Taj Pharmaceuticals places its main business as a Pharmaceuticals manufacturing and exports of generic drug supply of Methotrexate Injection USP ; primarily of pharmaceuticals preparations known as Methotrexate Injection USP ; as well as more than 100+ generic equivalent drug. Taj Pharmaceuticals has performed these business activities related to exports of Methotrexate Injection USP 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 Methotrexate Injection USP ; at Taj Pharma we will appropriately meet diverse needs for Methotrexate Injection USP export manufacturing in a wide range of activities from investigation of possible formulations of Methotrexate Injection USP , formulation development, making applications to the international regulatory authorities for marketing approval, validation of Methotrexate Injection USP 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.
Leading Methotrexate Injection USP Manufacturers, Suppliers in India
Taj Pharmaceuticals, one of the leading Methotrexate Injection USP Manufacturers India brings the best-quality products. The company carries the rich experience in the niche manufacturing of Methotrexate Injection USP .
Taj Pharmaceuticals is reputed manufacturer and Methotrexate Injection USP suppliers in India prefer Taj Pharmaceuticals due to the reliability and purity of products.
Taj Pharmaceuticals, the well-known Methotrexate Injection USP API Manufacturer in India gives the assurance of high-quality and purity. The stringent quality-control ensure that every batch of the drug brings a consistent standard.
As Methotrexate Injection USP Exporters, we can cater business queries from the following geographies:
Turkey, Cyprus, Guatemala, El Salvador, Cayman Island, Jamaica, Mozambique, Ecuador, Colombia, Malawi, St Lucia, Papua New Guinea, Gambia, Venezuela, Trinidad & Tobago, Somalia, Guyana, Libya, Seychelles, All West Indies Country, Sierra Leone
When it comes to manufacturing any Methotrexate Injection USP , Taj Pharmaceutical always leads. The continuous efforts to become one of the best Methotrexate Injection USP manufacturers has made the company to bring the world-class standards – from research laboratories to maintenance. A wide range of life saving Drugs available at Taj Pharma. To manufacture excellent quality Methotrexate Injection USP we use high-standard equipment, with the latest technology. Our standard drugs satisfy most of our customers.
Third Party Manufacturer of Methotrexate Injection USP
Taj Pharmaceuticals is popular for manufacturing a lot of pharmaceutical and medical products along with Methotrexate Injection USP . Taj Pharma is very famous for its competitive price range as well which are nicely suitable for a common man.
Sharing the safest methods and providing the safest product to the customer and client is our first purity and duty as well. Taj Pharma’s keen focus that we provide safety to consume Methotrexate Injection USP to our customer along with that we also take care of our workers and all the professionals who are implementing the tasks of manufacturing these injections. Taj Pharmaceuticals has a few manufacturing units and plants in India where all the processes go through under the keen guidance of experts by which create more chances of production of a perfect product with present accuracy. Taj Pharmaceuticals continues its participation in every pharmaceutical event ensures us that we can be able to polish and update our firm. Taj Pharmaceuticals is one of the leading Methotrexate Injection USP Manufacturers Suppliers all over India. WHO:GMP Certified Third Party Contract Manufacturing also available.
Taj Pharmaceuticals is an ISO 9001:2015, WHO:GMP, GLP Certified Pharmaceuticals Company in Mumbai and Gujarat offering more than 1500+ high quality Medical Products. Taj Pharmaceuticals has its own manufacturing unit with sections like Injectable, Tablets, Capsules, Soft Gelatin Capsules, Oral Liquid (Syrup & Suspension), Oral Dry Syrup, External Liquids, Ointments, Creams, Betalactum Products, General Products , Nutraceuticals, Soaps, Shampoo, Eye Drops, Ear Drops , Oral Sachets & Powders , External Powder & Cosmetics. Taj Pharmaceutical has 1500+ product approvals of which many are latest molecules launched in industry. Taj Pharma India caters to all segments like Gynaecology, Dermatology, Ophthalmic, Critical Care, Paediatric, Orthopaedic, Ayurvedic, Nutraceuticals, Cosmetics, Oncology, Cardiac-Diabetic & many more. Third Party Manufacturing & Contract Manufacturing also available.
- Built up area of approx. 100,000 sq. ft with separate areas for production, stores & non process blocks.
- Engineering, Utilities to commensurate production facility
- Designed and built as per vertical flow concept of man – material movement
- Highly skilled and experienced technical staff
- Immaculate environmental monitoring, calibration and validation programme
- c-GMP compliant with latest manufacturing equipments
- Dedicated & modular laboratories with latest sophisticated instruments as per GLP norms
- Automated access control system and fully equipped cameras
- Separate entry and exit for man, material and service personnel for both process blocks
- In house water & sewerage treatment plant.
Online Order Tracking
In order to solve the major problem faced by many pharmaceuticals clients is they are always in a state of dilemma that when their product will be dispatched. They are not able to track the lifecycle of product in a transparent manner which causes loss of trust and commitment. Taj Pharmaceuticals has developed a fully automatic online solution which helps you to immediately determine the production stage of products at any given time. Here are the few stages which you can see:
- Design Approved
- Carton/ Foil Received
- Raw Material Ok & Batch Planned
- Batch Processed
- Testing Done
- Packing Done
- Dispatched from Plant
- Tracking No.
100% Transparent Process
In order to give you full confidence over the quality of product we provide you with many resources such as:
- COA (Certificate of Analysis)
- Raw Material Procurement Certificate
- Batch Inspection Report
- Detailed Test Report across 25+ different parameters
With the sufficient proofs in your hand it becomes easy to convince others about the quality of your products.
New Market Opportunities
We want that our customers should always stay ahead of the competition in market. So in order to make it sure, we provide our customers with valuable market intelligence based on our 30+ years of experience in pharma industry.
- Timely updates about new product launches.
- Competitor Analysis
- Correct MRP Guidance
- Promotional Material with training
At Taj Pharmaceuticals, we use state-of-the-art technology, the most stringent operating procedures and we have earned a name for ourselves for maintaining the highest standards of quality. Taj Pharma India is proud to have received the WHO:GMPcertification from Food and Drugs Control Department, Daman and Gujarat.
Taj Pharmaceuticals provide Medicines of good quality at competitive price from good Manufacturers. Domestic and Export both.
It’s great pleasure to introducing ourselves as one of the leading pharmaceutical company based in Mumbai, Maharashtra and Gujarat, India. Taj Pharmaceuticals Contract Manufacturing Division is marketing partner of some WHO, GMP, GLP, ISO9001-2008 certified manufacturers.
Taj Pharmaceuticals is a leading pharmaceutical Company. We are specialized in providing quality products include complete range of all medicine (Human and Vet) which includes,
- Dry syrups
- Dry injections
- Liquid Injections
- Soft gelatin
- Penecilline group
- Cefalosporin group
- Neutra products etc.
Some of the salient features of our products are:-
- Accurate composition
- Long shelf life
Taj Pharmaceuticals’s manufacturing partners having state-of-the-art infrastructure ensures that all our products are of high quality and adhere to international standards. We have a well-equipped production unit that allows us to meet the ever growing demands of the industry. Taj Pharmaceuticals manufacturing facilities are well-maintained to ensure efficient utilization of resources. Our manufacturing partners have a technologically advanced range of equipment and machinery to facilitate high levels of production.
Taj Pharmaceuticals have developed a team of experienced professionals that form the backbone of Taj Pharmaceuticals Manufacturing partners, Their dedication and hard work has allowed us to attain a position of respect and repute in the industry. Owing to their efforts and creative approach, we have continuously progressed towards expansion of our business. Their in-depth knowledge and expertise coupled with invaluable guidance of our mentor, ensures competent and efficient execution of our methodologies.
Taj Pharmaceuticals and its Manufacturing partners aim to become a leading player in global market. To succeed in this endeavour, Taj Pharmaceuticals Manufacturing partners have a nurtured a team of dedicated quality analysts who conduct periodic tests on all production stages from procurement of raw materials till the formulation of final product. Taj Pharma ensure that our unit is hygienically maintained and development & packaging of our products is done under hygienic environment. The parameters on which our products are quality tested are:-
- Shelf Life
Taj Pharmaceuticals and its Manufacturing partners follows business ethics, zero-tolerance quality policy and a highly qualified team are our strengths. We strive to maintain long lasting relationship with our clients by meeting their requirements effectively and efficiently. The numerous factors contributing to our success are:-
- Experienced & Skilled Team
- stringent quality checks
- Proper infrastructure and machinery
- Prompt delivery
- Competitive Prices
- Wide clientele
Taj Pharmaceuticals is a one stop solution for Export/Domestic 3rd party for all Pharmaceutical Formulations.
Taj Pharmaceuticals is looking forward for your co-operation towards development of concrete business and Hoping for a strong and good business relationship in future.
To know more please do visit our website www.tajpharma.in
|WARNINGS : The dose must be adjusted carefully depending on the body surface area if methotrexate is used for the treatment of tumour diseases.Fatal cases of intoxication have been reported after administration of incorrect calculated doses. Health care professionals and patients should be fully informed about toxic effects.|
Treatment should be initiated by or occur in consultation with a doctor with significant experience in cytostatic treatment.
Methotrexate can be administered intramuscularly, intravenously, intra-arterial or intrathecally. The dosage is generally calculated per m2 body surface area or body weight. Doses of over 100 mg methotrexate always require subsequent administration of folinic acid (See calcium folinate rescue).
The application and dosage recommendations for the administration of methotrexate for different indications varies considerably. Some common dosages which have been used in different indications are given below. None of these dosages can currently be described as standard therapy. Since the application and dosage recommendations for therapy with methotrexate at high and low dosages vary, only the most commonly used guidelines are given. Current published protocols should be consulted for dosages and the method and sequence of administration.
Methotrexate can be given as convention low dose therapy, intermediate dose therapy, high dose therapy and intrathecal administration.
Conventional low dose therapy: 15-50 mg/m2 body surface area per week intravenously or intramuscularly in one or more doses. 40-60 mg/m2 body surface area (for head and neck cancer) once weekly as intravenous bolus injection.
Intermediate dose therapy: Between 100 mg/m2 to 1000 mg/m2 body surface area in single dose. In advanced squamous epithelial and bladder cancer, intermediate doses of methotrexate up to 100- 200 mg/m2 can be used. (See Calcium folinate rescue).
High dose therapy: In several malignant diseases, including malignant lymphoma, acute lymphatic leukaemia, osteogenic sarcoma and metastatic choriocarcinoma, doses of 1000 mg methotrexate or more per m2 body surface area may be used, administered over a 24-hour period. Administration of folinic acid must begin with 10-15 mg (6-12 mg/m2) to be given 12-24 hours after starting methotrexate treatment (Further refer to therapy protocols, See calcium folinate rescue).
Calcium folinate rescue
Since the calcium folinate rescue dosage regimen depends heavily on the posology and method of the intermediate or high-dose methotrexate administration, the methotrexate protocol will dictate the dosage regimen of calcium folinate rescue. Therefore, it is best to refer to the applied intermediate or high dose methotrexate protocol for posology and method of administration of calcium folinate.
In addition to calcium folinate administration, measures to ensure the prompt excretion of methotrexate (maintenance of high urine output and alkalinisation of urine) are integral parts of the calcium folinate rescue treatment. Renal function should be monitored through daily measurements of serum creatinine.
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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: firstname.lastname@example.org, 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