1. Name of the medicinal product

Imatinib Capsules 100 mg Taj Pharma

  1. Qualitative and quantitative composition

Each hard gelatin capsule contains:
Imatinib Mesylate
Equivalent to Imatinib                           100mg
Excipients                                                 q.s.
Colours: Approved colours used in capsule shell

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Capsule, hard.

  1. Clinical particulars

4.1 Therapeutic indications

Imatinib is indicated for the treatment of

– paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.

– paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

– adult patients with Ph+ CML in blast crisis.

– adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.

– adult patients with relapsed or refractory Ph+ ALL as monotherapy.

– adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

– adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.

The effect of imatinib on the outcome of bone marrow transplantation has not been determined.

Imatinib is indicated for

– the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Imatinib Capsules manufacturers in India {Taj Pharmaceuticals}; best quality suppliers and exporter of Imatinib Capsules

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 Imatinib Capsules. Taj Pharmaceuticals places its main business as a Pharmaceuticals manufacturing and exports of generic drug supply of Imatinib Capsules; primarily of pharmaceuticals preparations known as Imatinib Capsules; as well as more than 100+ generic equivalent drug. Taj Pharmaceuticals has performed these business activities related to exports of Imatinib Capsules 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 Imatinib Capsules; at Taj Pharma we will appropriately meet diverse needs for Imatinib Capsules export manufacturing in a wide range of activities from investigation of possible formulations of Imatinib Capsules, formulation development, making applications to the international regulatory authorities for marketing approval, validation of Imatinib Capsules 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 Imatinib Capsules

  1. WHO-cGMP Certified
    Taj Pharmaceuticals is manufacturesImatinib Capsules under WHO-cGMP Plant. Taj Pharma is licenced to manufacture Imatinib Capsules formulation from Food and Drug Administration of Indian authorities as the rules and regulations with all compliances for international markets.
  2. 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 Imatinib Capsules 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

Imatinib Capsules Regulatory Documents:

  1. Certificate of Analysis (COA)
  2. Method of Analysis (MOA)
  3. Stability Data (Accelerated stability / Long term stability / Zone 4b)
  4. CTD Dossier / ACTD Dossiers / eCTD Dossiers
  5. Certificate of Pharmaceuticals Product (COPP)
  6. Free Sale Certificate (FSC)

Leading Imatinib Capsules Manufacturers, Suppliers in India

Taj Pharmaceuticals, one of the leading Imatinib Capsules Manufacturers India brings the best-quality products. The company carries the rich experience in the niche manufacturing of Imatinib Capsules.

Taj Pharmaceuticals is reputed manufacturer and Imatinib Capsules suppliers in India prefer Taj Pharmaceuticals due to the reliability and purity of products.

Taj Pharmaceuticals, the well-known Imatinib Capsules 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 Imatinib Capsules 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 Imatinib Capsules, Taj Pharmaceutical always leads. The continuous efforts to become one of the best Imatinib Capsules 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 Imatinib Capsules we use high-standard equipment, with the latest technology. Our standard drugs satisfy most of our customers.

Third Party Manufacturer of Imatinib Capsules

Taj Pharmaceuticals is popular for manufacturing a lot of pharmaceutical and medical products along with Imatinib Capsules. 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 Imatinib Capsules 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 Imatinib Capsules Manufacturers Suppliers all over India. WHO:GMP Certified Third Party Contract Manufacturing also available.

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.

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,

  1. Tabs
  2. Dry syrups
  3. Capsules
  4. Dry injections
  5. Liquid Injections
  6. Soft gelatin
  7. Penecilline group
  8. Cefalosporin group
  9. Liquid
  10. Sachets
  11. Ointment/Creams
  12. 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

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