WARNINGS
Anaphylactic Reactions, Cross-sensitivity with Other Alkylating Agents
Anaphylactic reactions including those with fatal outcomes have been reported in association with cyclophosphamide.
Possible cross-sensitivity with other alkylating agents has been reported.
Myelosuppression, Immunosuppression, Infections
Treatment with cyclophosphamide may cause myelosuppression and significant suppression of immune responses.
Cyclophosphamide-induced myelosuppression can cause leukopenia, neutropenia, thrombocytopenia (associated with a higher risk of bleeding events), and anaemia.
Severe immunosuppression has lead to serious, sometimes fatal, infections. Sepsis and septic shock have also been reported. Infections reported with cyclophosphamide include pneumonias, as well as other bacterial, fungal, viral, protozoal, and parasitic infections.
Latent infections can be reactivated. Reactivation has been reported for various bacterial, fungal, viral, protozoal, and parasitic infections.
Infections must be treated appropriately.
Antimicrobial prophylaxis may be indicated in certain cases of neutropenia at the discretion of the managing physician.
In case of neutropenic fever, antibiotics and/or antimycotics must be given.
Cyclophosphamide should be used with caution, if at all, in patients with severe impairment of bone marrow function and in patients with severe immunosuppression.
Unless essential, cyclophosphamide should not be administered to patients with a leukocyte count below 2500 cells/microlitre (cells/ mm3 and/or a platelet count below 50,000 cells/microlitre (cells/mm3).
Cyclophosphamide treatment may not be indicated, or should be interrupted, or the dose reduced, in patients who have or who develop a serious infection.
In principle, the fall in the peripheral blood cell and thrombocyte count and the time taken to recover may increase with increasing doses of cyclophosphamide.
The nadirs of the reduction in leukocyte count and thrombocyte count are usually reached in weeks 1 and 2 of treatment. The bone marrow recovers relatively quickly, and the levels of peripheral blood cell counts normalize, as a rule, after approximately 20 days.
Severe myelosuppression must be expected particularly in patients pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy.
Close haematological monitoring is required for all patients during treatment.
Urinary Tract and Renal Toxicity
Hemorrhagic cystitis, pyelitis, ureteritis, and haematuria have been reported with cyclophosphamide therapy. Bladder ulceration/necrosis, fibrosis/contracture and secondary cancer may develop.
Urotoxicity may mandate interruption of treatment.
Cystectomy may become necessary due to fibrosis, bleeding, or secondary malignancy.
Cases of urotoxicity with fatal outcomes have been reported.
Urotoxicity can occur with short-term and long-term use of cyclophosphamide. Hemorrhagic cystitis after single doses of cyclophosphamide has been reported.
Past or concomitant radiation or busulfan treatment may increase the risk for cyclophosphamide-induced hemorrhagic cystitis.
Cystitis is, in general, initially abacterial. Secondary bacterial colonization may follow.
Before starting treatment, it is necessary to exclude or correct any urinary tract obstructions. See Section 4.3.
Urinary sediment should be checked regularly for the presence of erythrocytes and other signs of uro/nephrotoxicity.
Cyclophosphamide should be used with caution, if at all, in patients with active urinary tract infections.
Adequate treatment with mesna and/or strong hydration to force dieresis can markedly reduce the frequency and severity of bladder toxicity. It is important to ensure that patients empty the bladder at regular intervals.
Hematuria usually resolves in a few days after cyclophosphamide treatment is stopped, but it may persist.
It is usually necessary to discontinue cyclophosphamide therapy in instances of severe hemorrhagic cystitis.
Cyclophosphamide has also been associated with nephrotoxicity, including renal tubular necrosis.
Hyponatremia associated with increased total body water, acute water intoxication, and a syndrome resembling SIADH (syndrome of inappropriate secretion of antidiuretic hormone) have been reported in association with cyclophosphamide administration. Fatal outcomes have been reported.
Taj Pharmaceuticals LICENCES & CERTIFICATES for Cyclophosphamide 1g Injection, USP
- WHO-cGMP Certified
Taj Pharmaceuticals is manufacturesCyclophosphamide 1g Injection, USP under WHO-cGMP Plant. Taj Pharma is licenced to manufacture Cyclophosphamide 1g Injection, USP 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 Cyclophosphamide 1g 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
Cyclophosphamide 1g 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)
Contract Manufacturing
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.
Manufacturing Unit
- 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
WHO:GMP Certified
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.
- Name of the medicinal product
Cyclophosphamide 200mg Powder for Injection USP Taj Pharma
Cyclophosphamide 300mg Powder for Injection USP Taj Pharma
Cyclophosphamide 500mg Powder for Injection USP Taj Pharma
Cyclophosphamide 1000mg Powder for Injection USP Taj Pharma
Cyclophosphamide 2000mg Powder for Injection USP Taj Pharma
Cyclophosphamide Powder for Injection USP 3g Taj Pharma
- Qualitative and quantitative composition
a) Cyclophosphamide 200mg Powder for Injection USP
Each sterile vial contains:
Cyclophosphamide USP
Equivalent to Anhydrous Cyclophosphamide 200mg
b) Cyclophosphamide 300mg Powder for Injection USP
Each sterile vial contains:
Cyclophosphamide USP
Equivalent to Anhydrous Cyclophosphamide 300mg
c) Cyclophosphamide 500mg Powder for Injection USP
Each sterile vial contains:
Cyclophosphamide USP
Equivalent to Anhydrous Cyclophosphamide 500mg
d) Cyclophosphamide 1000mg Powder for Injection USP
Each sterile vial contains:
Cyclophosphamide USP
Equivalent to Anhydrous Cyclophosphamide 1000mg
e) Cyclophosphamide 2000mg Powder for Injection USP
Each sterile vial contains:
Cyclophosphamide USP
Equivalent to Anhydrous Cyclophosphamide 2000mg
f)Cyclophosphamide for Powder for Injection USP 3g Taj Pharma
Each vial contains:
Cyclophosphamide monohydrate USP
Equivalent to Cyclophosphamide (anhydrous) 3g
- PHARMACEUTICAL FORM
Powder for solution for injection.
A white crystalline powder contained in clear glass injection vials.
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,
- Tabs
- Dry syrups
- Capsules
- Dry injections
- Liquid Injections
- Soft gelatin
- Penecilline group
- Cefalosporin group
- Liquid
- Sachets
- Ointment/Creams
- Neutra products etc.
Some of the salient features of our products are:-
- Accurate composition
- Effective
- Pure
- Long shelf life
Our Infrastructure
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.
Our Team
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.
Quality Assurance
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:-
- Safety
- Composition
- Shelf Life
Our Strengths
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
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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: 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
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E-Mail: info ( @ ) tajpharma dot com
