- Name of the medicinal product
Gemcitabine USP 200 mg powder for solution for injection Taj Pharma
Gemcitabine USP 1000 mg powder for solution for injection Taj Pharma
- Qualitative and quantitative composition
a) Gemcitabine USP 200 mg powder for solution for injection Taj Pharma
Each sterile lyophilized vial contains
Gemcitabine hydrochloride USP
Equivalent to Gemitabine 200mg
Mannitol USP 1000mg
Sodium Acetate USP 62.5mg
Sodium Hydroxide USPNF q.s.
Hydrochloric Acid USPNF q.s.
b) Gemcitabine USP 1000 mg powder for solution for injection Taj Pharma
Each sterile lyophilized vial contains
Gemcitabine hydrochloride USP
Equivalent to Gemitabine 1000mg
Mannitol USP 1000mg
Sodium Acetate USP 62.5mg
Sodium Hydroxide USPNF q.s.
Hydrochloric Acid USPNF q.s.
For the full list of excipients, see section 6.1.
- Pharmaceutical form
Powder for solution for injection.
- Clinical particulars
4.1 Therapeutic indications
Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.
Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.
Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.
Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy.
Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
We are exporting our Gemcitabine Injection 1000mg 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
Gemcitabine Injection 1000mg 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)
Leading Gemcitabine Injection 1000mg Manufacturers, Suppliers in India
Taj Pharmaceuticals, one of the leading Gemcitabine Injection 1000mg Manufacturers India brings the best-quality products. The company carries the rich experience in the niche manufacturing of Gemcitabine Injection 1000mg.
Taj Pharmaceuticals is reputed manufacturer and Gemcitabine Injection 1000mg suppliers in India prefer Taj Pharmaceuticals due to the reliability and purity of products.
Taj Pharmaceuticals, the well-known Gemcitabine Injection 1000mg 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 Gemcitabine Injection 1000mg 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 Gemcitabine Injection 1000mg, Taj Pharmaceutical always leads. The continuous efforts to become one of the best Gemcitabine Injection 1000mg 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 Gemcitabine Injection 1000mg we use high-standard equipment, with the latest technology. Our standard drugs satisfy most of our customers.
Third Party Manufacturer of Gemcitabine Injection 1000mg
Taj Pharmaceuticals is popular for manufacturing a lot of pharmaceutical and medical products along with Gemcitabine Injection 1000mg. 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 Gemcitabine Injection 1000mg 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 Gemcitabine Injection 1000mg 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.
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
Fax No.:+91 22 2634 1274
E-Mail: info ( @ ) tajpharma dot com