Methotrexate (Methotrexate)

Trade Name : Methotrexate

Hikma Pharmaceuticals USA Inc.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 1 g/1

METHOTREXATE Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Methotrexate (Methotrexate) which is also known as Methotrexate and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 1 g/1 per ml. Read more

Methotrexate (Methotrexate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Methotrexate is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis.
Chemically methotrexate is L-(+)--[-[[(2,4-Diamino-6-pteridinyl)methyl]methylamino]-benzoyl]glutamic acid.
The structural formula is:
CHNOu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0M.W.=454.44
Methotrexate for injection (Preservative Free) is sterile and non-pyrogenic and may be given by the intramuscular, intravenous, intra-arterial or intrathecal route. (See .)
Methotrexate for Injection, USP, Lyophilized, Preservative Freen- for single use only
Each 1 gram vial of lyophilized powder contains methotrexate sodium equivalent to 1 gram methotrexate. Contains no preservative. Sodium hydroxide and, if necessary, hydrochloric acid are added during manufacture to adjust the pH. The 1 gram vial contains approximately 7 mEq sodium.

Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one- carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues.
The mechanism of action in rheumatoid arthritis is unknown; it may affect immune function. Two reports describe methotrexate inhibition of DNA precursor uptake by stimulated mononuclear cells, and another describes in animal polyarthritis partial correction by methotrexate of spleen cell hyporesponsiveness and suppressed IL 2 production. Other laboratories, however, have been unable to demonstrate similar effects. Clarification of methotrexateu2019s effect on immune activity and its relation to rheumatoid immunopathogenesis await further studies.
In patients with rheumatoid arthritis, effects of methotrexate on articular swelling and tenderness can be seen as early as 3 to 6 weeks. Although methotrexate clearly ameliorates symptoms of inflammation (pain, swelling, stiffness), there is no evidence that it induces remission of rheumatoid arthritis nor has a beneficial effect been demonstrated on bone erosions and other radiologic changes which result in impaired joint use, functional disability, and deformity.
Most studies of methotrexate in patients with rheumatoid arthritis are relatively short term (3 to 6 months). Limited data from long-term studies indicate that an initial clinical improvement is maintained for at least two years with continued therapy.
In psoriasis, the rate of production of epithelial cells in the skin is greatly increased over normal skin. This differential in proliferation rates is the basis for the use of methotrexate to control the psoriatic process.
Methotrexate in high doses, followed by leucovorin rescue, is used as a part of the treatment of patients with non-metastatic osteosarcoma. The original rationale for high-dose methotrexate therapy was based on the concept of selective rescue of normal tissues by leucovorin. More recent evidence suggests that high-dose methotrexate may also overcome methotrexate resistance caused by impaired active transport, decreased affinity of dihydrofolic acid reductase for methotrexate, increased levels of dihydrofolic acid reductase resulting from gene amplification, or decreased polyglutamation of methotrexate. The actual mechanism of action is unknown.
In a 6-month double-blind, placebo-controlled trial of 127 pediatric patients with juvenile rheumatoid arthritis (JRA) (mean age, 10.1 years; age range, 2.5 to 18 years; mean duration of disease, 5.1 years) on background nonsteroidal anti-inflammatory drugs (NSAIDs) and/or prednisone, methotrexate given weekly at an oral dose of 10 mg/m provided significant clinical improvement compared to placebo as measured by either the physicianu2019s global assessment, or by a patient composite (25% reduction in the articular-severity score plus improvement in parent and physician global assessments of disease activity). Over two-thirds of the patients in this trial had polyarticular-course JRA, and the numerically greatest response was seen in this subgroup treated with 10 mg/m/wk methotrexate. The overwhelming majority of the remaining patients had systemic-course JRA. All patients were unresponsive to NSAIDs; approximately one-third were using low dose corticosteroids. Weekly methotrexate at a dose of 5 mg/m was not significantly more effective than placebo in this trial.
Two Pediatric Oncology Group studies (one randomized and one non-randomized) demonstrated a significant improvement in relapse-free survival in patients with non-metastatic osteosarcoma, when high-dose methotrexate with leucovorin rescue was used in combination with other chemotherapeutic agents following surgical resection of the primary tumor. These studies were not designed to demonstrate the specific contribution of high-dose methotrexate/leucovorin rescue therapy to the efficacy of the combination. However, a contribution can be inferred from the reports of objective responses to this therapy in patients with metastatic osteosarcoma, and from reports of extensive tumor necrosis following preoperative administration of this therapy to patients with non-metastatic osteosarcoma.

No data

Methotrexate can cause fetal death or teratogenic effects when administered to a pregnant woman. Methotrexate is contraindicated in pregnant women with psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus. Women of childbearing potential should not be started on methotrexate until pregnancy is excluded and should be fully counseled on the serious risk to the fetus (see ) should they become pregnant while undergoing treatment. Pregnancy should be avoided if either partner is receiving methotrexate; during and for a minimum of three months after therapy for male patients, and during and for at least one ovulatory cycle after therapy for female patients. (see n ).
Because of the potential for serious adverse reactions from methotrexate in breast fed infants, it is contraindicated in nursing mothers.
Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease should not receive methotrexate.
Patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes should not receive methotrexate.
Patients with psoriasis or rheumatoid arthritis who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia, should not receive methotrexate.
Patients with a known hypersensitivity to methotrexate should not receive the drug.

WARNINGS u2013 n- SEE BOXED WARNINGS
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For intrathecal and high-dose methotrexate therapy, use the preservative-free formulation of methotrexate. use the preserved formulation of methotrexate for intrathecal or high-dose therapy because it contains benzyl alcohol.
Use caution when administering high-dose methotrexate to patients receiving proton pump inhibitor (PPI) therapy. Case reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high doses), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. In two of these cases, delayed methotrexate elimination was observed when high-dose methotrexate was co-administered with PPIs, but was not observed when methotrexate was co- administered with ranitidine. However, no formal drug interaction studies of methotrexate with ranitidine have been conducted.

No data

IN GENERAL, THE INCIDENCE AND SEVERITY OF ACUTE SIDE EFFECTS ARE RELATED TO DOSE AND FREQUENCY OF ADMINISTRATION. THE MOST SERIOUS REACTIONS ARE DISCUSSED ABOVE UNDER ORGAN SYSTEM TOXICITY IN THE PRECAUTIONS SECTION. THAT SECTION SHOULD ALSO BE CONSULTED WHEN LOOKING FOR INFORMATION ABOUT ADVERSE REACTIONS WITH METHOTREXATE.
The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse effects are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection.
Other adverse reactions that have been reported with methotrexate are listed below by organ system. In the oncology setting, concomitant treatment and the underlying disease make specific attribution of a reaction to methotrexate difficult.
Alimentary System -
Blood and Lymphatic System Disorders -
Cardiovascular
Central Nervous System
Hepatobiliary Disorders
Infection n- Pneumocystis carinii n- Herpes zoster, H. simplex
H. simplex
Musculoskeletal System
Ophthalmic
Pulmonary System
Skin
Urogenital System
Other rarer reactions related to or attributed to the use of methotrexate such as nodulosis, vasculitis, arthralgia/myalgia, loss of libido/impotence, diabetes, osteoporosis, sudden death, lymphoma, including reversible lymphomas, tumor lysis syndrome, soft tissue necrosis, and osteonecrosis. Anaphylactoid reactions have been reported.

Leucovorin is indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate. Leucovorin administration should begin as promptly as possible. As the time interval between methotrexate administration and leucovorin initiation increases, the effectiveness of leucovorin in counteracting toxicity decreases. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin.
In cases of massive overdosage, hydration and urinary alkalinization may be necessary to prevent the precipitation of methotrexate and/or its metabolites in the renal tubules. Generally speaking, neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination. However, effective clearance of methotrexate has been reported with acute, intermittent hemodialysis using a high-flux dialyzer (Wall, SM et al: 28(6): 846-854, 1996).
Accidental intrathecal overdosage may require intensive systemic support, high-dose systemic leucovorin, alkaline diuresis and rapid CSF drainage and ventriculolumbar perfusion.
In postmarketing experience, overdose with methotrexate has generally occurred with oral and intrathecal administration, although intravenous and intramuscular overdose have also been reported.
Reports of oral overdose often indicate accidental daily administration instead of weekly (single or divided doses). Symptoms commonly reported following oral overdose include those symptoms and signs reported at pharmacologic doses, particularly hematologic and gastrointestinal reaction. For example, leukopenia, thrombocytopenia, anemia, pancytopenia, bone marrow suppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration, gastrointestinal bleeding. In some cases, no symptoms were reported. There have been reports of death following overdose. In these cases, events such as sepsis or septic shock, renal failure, and aplastic anemia were also reported.
Symptoms of intrathecal overdose are generally central nervous system (CNS) symptoms, including headache, nausea and vomiting, seizure or convulsion, and acute toxic encephalopathy. In some cases, no symptoms were reported. There have been reports of death following intrathecal overdose. In these cases, cerebellar herniation associated with increased intracranial pressure, and acute toxic encephalopathy have also been reported.
Glucarpidase is indicated for the treatment of toxic methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function (refer to the glucarpidase prescribing information).
If glucarpidase is used, do not administer leucovorin within two hours before or after a dose of glucarpidase because leucovorin is a substrate for glucarpidase. There are published case reports of intravenous and intrathecal glucarpidase treatment to hasten clearance of methotrexate in cases of overdose.

Neoplastic Diseases
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For intrathecal and high-dose methotrexate therapy, use the preservative-free formulation of methotrexate. use the preserved formulation of methotrexate for intrathecal or high-dose therapy because it contains benzyl alcohol.
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Oral administration in tablet form is often preferred when low doses are being administered since absorption is rapid and effective serum levels are obtained. Methotrexate sodium (preservative free) injectable products may be given by the intramuscular, intravenous, intra-arterial or intrathecal route.
Choriocarcinoma and similar trophoblastic diseases-
Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with methotrexate has been recommended.
Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole.
Methotrexate is administered in these disease states in doses similar to those recommended for choriocarcinoma.
Leukemia-
Methotrexate alone or in combination with steroids was used initially for induction of remission in acute lymphoblastic leukemias. More recently corticosteroid therapy, in combination with other antileukemic drugs or in cyclic combinations with methotrexate included, has appeared to produce rapid and effective remissions. When used for induction, methotrexate in doses of 3.3 mg/m in combination with 60 mg/mof prednisone, given daily, produced remissions in 50% of patients treated, usually within a period of 4 to 6 weeks. Methotrexate in combination with other agents appears to be the drug of choice for securing maintenance of drug-induced remissions. When remission is achieved and supportive care has produced general clinical improvement, maintenance therapy is initiated, as follows: Methotrexate is administered 2 times weekly either by mouth or intramuscularly in total weekly doses of 30 mg/m. It has also been given in doses of 2.5 mg/kg intravenously every 14 days. If and when relapse does occur, reinduction of remission can again usually be obtained by repeating the initial induction regimen.
A variety of combination chemotherapy regimens have been used for both induction and maintenance therapy in acute lymphoblastic leukemia. The physician should be familiar with the new advances in antileukemic therapy.
Meningeal Leukemia-
The cerebrospinal fluid volume is dependent on age and not body surface area. The CSF is at 40% of the adult volume at birth and reaches the adult volume in several years.
Intrathecal methotrexate administration at a dose of 12 mg/m (maximum 15 mg) has been reported to result in low CSF methotrexate concentrations and reduced efficacy in pediatric patients and high concentrations and neurotoxicity in adults. The following dosage regimen is based on age instead of body surface area:
In one study in patients under the age of 40, this dosage regimen appeared to result in more consistent CSF methotrexate concentrations and less neurotoxicity. Another study in pediatric patients with acute lymphocytic leukemia compared this regimen to a dose of 12 mg/m (maximum 15 mg), a significant reduction in the rate of CNS relapse was observed in the group whose dose was based on age.
Because the CSF volume and turnover may decrease with age, a dose reduction may be indicated in elderly patients.
For the treatment of meningeal leukemia, intrathecal methotrexate may be given at intervals of 2 to 5 days. However, administration at intervals of less than 1 week may result in increased subacute toxicity. Methotrexate is administered until the cell count of the cerebrospinal fluid returns to normal. At this point one additional dose is advisable.
For prophylaxis against meningeal leukemia, the dosage is the same as for treatment except for the intervals of administration. On this subject, it is advisable for the physician to consult the medical literature.
Untoward side effects may occur with any given intrathecal injection and are commonly neurological in character. Large doses may cause convulsions. Methotrexate given by the intrathecal route appears significantly in the systemic circulation and may cause systemic methotrexate toxicity. Therefore, systemic antileukemic therapy with the drug should be appropriately adjusted, reduced or discontinued. Focal leukemic involvement of the central nervous system may not respond to intrathecal chemotherapy and is best treated with radiotherapy.
Lymphomas-
Mycosis fungoides (cutaneous T cell lymphoma) -
Osteosarcoma-
N Engl J of Med
When these higher doses of methotrexate are to be administered, the following safety guidelines should be closely observed.
GUIDELINES FOR METHOTREXATE THERAPY WITH LEUCOVORIN RESCUE
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CAUTION: DO NOT ADMINISTER LEUCOVORIN INTRATHECALLY.
Psoriasis, Rheumatoid Arthritis, and Juvenile Rheumatoid Arthritis
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Adult Rheumatoid Arthritis:
Polyarticular-Course Juvenile Rheumatoid Arthritis:
For either adult RA or polyarticular-course JRA, dosages may be adjusted gradually to achieve an optimal response. Limited experience shows a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression, at doses greater than 20 mg/wk in adults. Although there is experience with doses up to 30 mg/m/wk in children, there are too few published data to assess how doses over 20 mg/m/wk might affect the risk of serious toxicity in children.
Experience does suggest, however, that children receiving 20 to 30 mg/m/wk (0.65 to 1 mg/kg/wk) may have better absorption and fewer gastrointestinal side effects if methotrexate is administered either intramuscularly or subcutaneously.
Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.
The optimal duration of therapy is unknown. Limited data available from long-term studies in adults indicate that the initial clinical improvement is maintained for at least two years with continued therapy. When methotrexate is discontinued, the arthritis usually worsens within 3 to 6 weeks.
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The patient should be fully informed of the risks involved and should be under constant supervision of the physiciann- Arrayn- Arrayn- Arrayn- Arrayn- Array
All schedules should be continually tailored to the individual patient. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects (See ). Maximal myelosuppression usually occurs in seven to ten days.
Psoriasis: Recommended Starting Dose Schedule
u00a0
Dosages in each schedule may be gradually adjusted to achieve optimal clinical response; 30 mg/week should not ordinarily be exceeded.
Once optimal clinical response has been achieved, each dosage schedule should be reduced to the lowest possible amount of drug and to the longest possible rest period. The use of methotrexate may permit the return to conventional topical therapy, which should be encouraged.
Handling and Disposal
Reconstitution of Lyophilized Powders
Methotrexate for injection should be reconstituted with an appropriate sterile, preservative free medium such as 5% dextrose solution, USP or sodium chloride injection, USP. . When high doses of methotrexate are administered by IV infusion, the total dose is diluted in 5% dextrose solution, USP.
For intrathecal injection, reconstitute to a concentration of 1 mg/mL with an appropriate sterile, preservative free medium such as sodium chloride injection, USP.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Methotrexate for Injection, USP (preservative free) is supplied in a 1 gram, single-dose vial of lyophilized powder containing 1 gram methotrexate as the base in the following package strength:
NDC 0143-9830-01 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. .
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
For Product Inquiry call 1-877-845-0689.

No data

u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0Manufactured by
THYMOORGAN PHARMAZIE GmbH,
Schiffgraben 23, 38690 Goslar, Germany
u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0Distributed by
u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0West-Ward Pharmaceuticals
Eatontown, NJ 07724 USA
Revised August 2019
127.207.008/02

No data

NDC 0143-9830-01
Rx only
Methotrexate for Injection, USP
1 g/vial
Sterile, Lyophilized
Preservative-Free
Cytotoxic Agent
See package insert for routes of administration

No data

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Methotrexate (Methotrexate)

Trade Name : Methotrexate

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Methotrexate (Methotrexate)

Trade Name : Methotrexate

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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