Epirubicin Hydrochloride (Epirubicin Hydrochloride)

Trade Name : Epirubicin Hydrochloride

West-Ward Pharmaceuticals Corp

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Strength 2 mg/mL

EPIRUBICIN HYDROCHLORIDE Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]

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WARNING: SEVERE OR LIFE-THREATENING HEMATOLOGICAL AND OTHER ADVERSE REACTIONS
See full prescribing information for complete boxed warning

u2022Severe local tissue necrosis associated with extravasation during administration (5.9)
u2022Myocardial toxicity, manifested in its most severe form by potentially fatal congestive heart failure (CHF) (5.3)
u2022Secondary acute myelogenous leukemia (AML) (5.4)
u2022Reduce dosage in patients with impaired hepatic function (5.5)
u2022Severe myelosuppression (5.2)
u2022Administer only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents (5)

Epirubicin Hydrochloride Injection, USPu00a0is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer n
Epirubicin Hydrochloride Injection, USPu00a0is an anthracycline topoisomerase II inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer u00a0.

When possible, to reduce the risk of developing cardiotoxicity in patients receiving epirubicin hydrochloride injection after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, epirubicin hydrochloride injection-based therapy should be delayed until the other agents have cleared from the circulation n
Administer epirubicin hydrochloride injection by intravenous infusion. Give epirubicin hydrochloride injection in repeated 3 to 4 week cycles. The total dose of epirubicin hydrochloride injection may be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle. The recommended dosages of epirubicin hydrochloride injection are as follows:

Administer intravenously in repeated 3 to 4 week cycles, either total dose on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle u00a0.
The recommended starting dose of epirubicin hydrochloride injection is 100 to 120 mg/m. Dosage reductions are possible when given in certain combinationsu00a0
Dosage adjustments after the first treatment cycle should be made based on hematologic and nonhematologic toxicities u00a0
Reduce dose in patients with hepatic impairment (u00a0, u00a0, u00a0).
Consider lower doses in patients with severe renal impairmentu00a0u00a0 u00a0, u00a0).

Epirubicin Hydrochloride Injection, USPu00a0is provided in glass single-use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following sizes: 50 mg/25 mL and 200 mg/100 mL.
Single use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution (50 mg/25 mL and 200 mg/100 mL) u00a0

Patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions:
u2022 cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias n
u2022 Previous treatment with maximum cumulative dose of anthracyclines n
u2022 Hypersensitivity to epirubicin hydrochloride, other anthracyclines, or anthracenediones n
Patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm cardiomyopathy and/or heart failure, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction u00a0

Administer epirubicin hydrochloride injection only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Before beginning treatment with epirubicin hydrochloride, patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment. Also, precede initial treatment with epirubicin hydrochloride by a careful baseline assessment of blood counts; serum levels of total bilirubin, AST, and creatinine; and cardiac function as measured by left ventricular ejection function (LVEF). Carefully monitor patients during treatment for possible clinical complications due to myelosuppression. Supportive care may be necessary for the treatment of severe neutropenia and severe infectious complications. Monitoring for potential cardiotoxicity is also important, especially with greater cumulative exposure to epirubicin hydrochloride.

u2022A dose-dependent, reversible leukopenia and/or neutropenia is the predominant manifestation of hematologic toxicity associated with epirubicin hydrochloride and represents the most common acute dose-limiting toxicity u00a0
u2022Cardiotoxicity is a known risk of anthracycline treatment and may be manifested by early (or acute) or late (delayed) events (u00a0).
u2022The occurrence of secondary acute myelogenous leukemia, with or without a preleukemic phase, has been reported in patients treated with anthracyclinesu00a0
u2022Serum total bilirubin and AST levels should be evaluated before and during treatment with epirubicin hydrochloride. Patients with elevated bilirubin or AST may experience slower clearance of drug with an increase in overall toxicity. Lower doses are recommended in these patients. Patients with severe hepatic impairment have not been evaluated u00a0
u2022Serum creatinine should be assessed before and during therapy. Dosage adjustment is necessary in patients with serum creatinine >5 mg/dL. Patients undergoing dialysis have not been studied u00a0
u2022Epirubicin hydrochloride may induce hyperuricemia as a consequence of the extensive purine catabolism that accompanies drug-induced rapid lysis of highly chemosensitive neoplastic cells (tumor-lysis syndrome)u00a0
u2022Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including epirubicin hydrochloride may result in serious or fatal infections u00a0).
u2022Venous sclerosis may result from an injection into a small vessel or from repeated injections into the same vein. Extravasation of epirubicin hydrochloride during the infusion may cause local pain, severe tissue lesions (vesication, severe cellulitis), and necrosis. Facial flushing, as well as local erythematous streaking along the vein, may be indicative of excessively rapid administration. It may precede local phlebitis or thrombophlebitis. Patients administered the 120 mg/mregimen of epirubicin hydrochloride as a component of combination chemotherapy should also receive prophylactic antibiotic therapy with trimethoprim-sulfamethoxazole (e.g., Septrau00ae, Bactrimu00ae) or a fluoroquinolone u00a0
u2022Epirubicin hydrochloride is emetigenic. Antiemetics may reduce nausea and vomiting; prophylactic use of antiemetics should be considered before administration of epirubicin hydrochloride, particularly when given in conjunction with other emetigenic drugs u00a0
u2022Administration of epirubicin hydrochloride after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation u00a0
u2022Thrombophlebitis and thromboembolic phenomena, including pulmonary embolism (in some cases fatal) have been coincidentally reported with the use of epirubicin hydrochloride u00a0).
u2022Epirubicin hydrochloride can cause fetal harm when administered to a pregnant woman. Advise women of potential risk to the fetus (u00a0).

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or n

In early breast cancer, acute adverse events occurring in u226510% of patients are leukopenia, neutropenia, anemia, thrombocytopenia, amenhorrhea, lethargy, nausea/vomiting, mucositis, diarrhea, infection, conjunctivitis/keratitis, alopecia, local toxicity and rash/itch (6).

No data

No data

There is no known antidote for overdoses of epirubicin hydrochloride. A 36 year old man with non-Hodgkinu2019s lymphoma received a daily 95 mg/m dose of epirubicin hydrochloride injection for 5 consecutive days. Five days later, he developed bone marrow aplasia, grade 4 mucositis, and gastrointestinal bleeding. No signs of acute cardiac toxicity were observed. He was treated with antibiotics, colony-stimulating factors, and antifungal agents, and recovered completely. A 63 year old woman with breast cancer and liver metastasis received a single 320 mg/m dose of epirubicin hydrochloride. She was hospitalized with hyperthermia and developed multiple organ failure (respiratory and renal), with lactic acidosis, increased lactate dehydrogenase, and anuria. Death occurred within 24 hours after administration of epirubicin hydrochloride. Additional instances of administration of doses higher than recommended have been reported at doses ranging from 150 to 250 mg/m. The observed adverse events in these patients were qualitatively similar to known toxicities of epirubicin. Most of the patients recovered with appropriate supportive care.
If an overdose occurs, provide supportive treatment (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) until the recovery of toxicities. Delayed CHF has been observed months after anthracycline administration. Observe patients carefully over time for signs of CHF and provide with appropriate supportive therapy.

Epirubicin Hydrochloride Injection, USPu00a0is an anthracycline cytotoxic agent, intended for intravenous administration. Epirubicin hydrochloride is supplied as a sterile, clear, red solution and is available inu00a0glass vials containing 50 and 200 mg of epirubicin hydrochloride as a preservative-free, ready-to-use solution. Each milliliter of solution contains 2 mg of epirubicin hydrochloride. Inactive ingredients include sodium chloride, and water for injection. The pH of the solution has been adjusted to 3.0 with hydrochloric acid.
Epirubicin hydrochloride is the 4-epimer of doxorubicin and is a semi-synthetic derivative of daunorubicin. The chemical name is (1,3)-3-Glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy- -L--hexopyranoside hydrochloride. The active ingredient is a red-orange hygroscopic powder, with the molecular formula CHNOu2022HCl and a molecular weight of 579.98.
The structural formula is as follows:

No data

Conventional long-term animal studies to evaluate the carcinogenic potential of epirubicin have not been conducted, but intravenous administration of a single 3.6 mg/kg epirubicin dose to female rats (about 0.2 times the maximum recommended human dose on a body surface area basis) approximately doubled the incidence of mammary tumors (primarily fibroadenomas) observed at 1 year. Administration of 0.5 mg/kg epirubicin intravenously to rats (about 0.025 times the maximum recommended human dose on a body surface area basis) every 3 weeks for ten doses increased the incidence of subcutaneous fibromas in males over an 18 month observation period. In addition, subcutaneous administration of 0.75 or 1 mg/kg/day (about 0.015 times the maximum recommended human dose on a body surface area basis) to newborn rats for 4 days on both the first and tenth day after birth for a total of eight doses increased the incidence of animals with tumors compared to controls during a 24-month observation period.
Epirubicin was mutagenic to bacteria (Ames test) either in the presence or absence of metabolic activation and to mammalian cells (HGPRT assay in V79 Chinese hamster lung fibroblasts) in the absence but not in the presence of metabolic activation. Epirubicin was clastogenic (chromosome aberrations in human lymphocytes) both in the presence and absence of metabolic activation and was also clastogenic (chromosome aberration in mouse bone marrow).
In fertility studies in rats, males were given epirubicin daily for 9 weeks and mated with females that were given epirubicin daily for 2 weeks prior to mating and through Day 7 of gestation. When 0.3 mg/kg/day (about 0.015 times the maximum recommended human single dose on a body surface area basis) was administered to both sexes, no pregnancies resulted. No effects on mating behavior or fertility were observed at 0.1 mg/kg/day, but male rats had atrophy of the testes and epididymis, and reduced spermatogenesis. The 0.1 mg/kg/day dose also caused embryolethality. An increased incidence of fetal growth retardation was observed in these studies at 0.03 mg/kg/day (about 0.0015 times the maximum recommended human single dose on a body surface area basis). Multiple daily doses of epirubicin to rabbits and dogs also caused atrophy of male reproductive organs. Single 20.5 and 12 mg/kg doses of intravenous epirubicin caused testicular atrophy in mice and rats, respectively (both approximately 0.5 times the maximum recommended human dose on a body surface area basis). A single dose of 16.7 mg/kg epirubicin caused uterine atrophy in rats.

Two randomized, open-label, multicenter studies evaluated the use of epirubicin hydrochloride injection 100 to 120 mg/m in combination with cyclophosphamide and fluorouracil for the adjuvant treatment of patients with axillary-node positive breast cancer and no evidence of distant metastatic disease (Stage II or III). Study MA-5 evaluated 120 mg/m of epirubicin hydrochloride per course in combination with cyclophosphamide and fluorouracil (CEF-120 regimen). This study randomized premenopausal and perimenopausal women with one or more positive lymph nodes to an epirubicin hydrochloride-containing CEF-120 regimen or to a CMF regimen. Study GFEA-05 evaluated the use of 100 mg/m of epirubicin hydrochloride per course in combination with fluorouracil and cyclophosphamide (FEC-100). This study randomized pre- and postmenopausal women to the FEC-100 regimen or to a lower-dose FEC-50 regimen. In the GFEA-05 study, eligible patients were either required to have 4 nodes involved with tumor or, if only 1 to 3 nodes were positive, to have negative estrogen- and progesterone-receptors and a histologic tumor grade of 2 or 3. A total of 1281 women participated in these studies. Patients with T4 tumors were not eligible for either study. Table 5 shows the treatment regimens that the patients received. Relapse-free survival was defined as time to occurrence of a local, regional, or distant recurrence, or disease-related death. Patients with contralateral breast cancer, second primary malignancy, or death from causes other than breast cancer were censored at the time of the last visit prior to these events.
Table 5. Treatment Regimens Used in Phase 3 Studies of Patients with Early Breast Cancer
a In women who underwent lumpectomy, breast irradiation was to be administered after completion of study chemotherapy.
b Patients also received prophylactic antibiotic therapy with trimethoprim-sulfamethoxazole or fluoroquinolone for the duration of their chemotherapy.
c All women were to receive breast irradiation after the completion of chemotherapy.
In the MA-5 trial, the median age of the study population was 45 years. Approximately 60% of patients had 1 to 3 involved nodes and approximately 40% had 4 nodes involved with tumor. In the GFEA-05 study, the median age was 51 years and approximately half of the patients were postmenopausal. About 17% of the study population had 1 to 3 positive nodes and 80% of patients had 4 involved lymph nodes. Demographic and tumor characteristics were well-balanced between treatment arms in each study.
Relapse-free survival (RFS) and overall survival (OS) were analyzed using Kaplan-Meier methods in the intent-to-treat (ITT) patient populations in each study. Results were initially analyzed after up to 5 years of follow-up and these results are presented in the text below and in Table 3. Results after up to 10 years of follow-up are presented in Table 6. In Study MA-5, epirubicin hydrochloride-containing combination therapy (CEF-120) showed significantly longer RFS than CMF (5 year estimates were 62% versus 53%, stratified logrank for the overall RFS p=0.013). The estimated reduction in the risk of relapse was 24% at 5 years. The OS was also greater for the epirubicin hydrochloride-containing CEF-120 regimen than for the CMF regimen (5 year estimate 77% versus 70%; stratified logrank for overall survival p=0.043; non-stratified logrank p=0.13). The estimated reduction in the risk of death was 29% at 5 years.
In Study GFEA-05, patients treated with the higher-dose epirubicin hydrochloride regimen (FEC-100) had a significantly longer 5 year RFS (estimated 65% versus 52%, logrank for the overall RFS p=0.007) and OS (estimated 76% versus 65%, logrank for the overall survival p=0.007) than patients given the lower dose regimen (FEC-50). The estimated reduction in risk of relapse was 32% at 5 years. The estimated reduction in the risk of death was 31% at 5 years. Results of follow-up up to 10 years (median follow-up = 8.8 years and 8.3 years, respectively, for Study MA-5 and Study GFEA-05) are presented in Table 6.
Although the trials were not powered for subgroup analyses, in the MA-5 study, improvements in favor of CEF-120 vs. CMF were observed, in RFS and OS both in patients with 1 to 3 node positive and in those with 4 node positive tumor involvement. In the GFEA-05 study, improvements in RFS and OS were observed in both pre- and postmenopausal women treated with FEC-100 compared to FEC-50.
Table 6. Efficacy Results from Phase 3 Studies of Patients with Early Breast Cancer*
*Based on Kaplan-Meier estimates
**Patients in MA-5 were stratified by nodal status (1 to 3, 4 to 10, and >10 positive nodes), type of initial surgery (lumpectomy versus mastectomy), and by hormone receptor status (ER or PR positive (10 fmol), both negative (<10 fmol), or unknown status). Patients in GFEA-05 were stratified by nodal status (1 to 3, 4 to 10, and >10 positive nodes).
u2020Hazard ratio: CMF:CEF-120 in MA-5, FEC-50:FEC-100 in GFEA-05
The Kaplan-Meier curves for RFS and OS from Study MA-5 are shown in Figures 3 and 4 and those for Study GFEA-05 are shown in Figures 5 and 6.
Figure 3. Relapse-Free Survival in Study MA-5
Figure 4. Overall Survival in Study MA-5
Figure 5. Relapse-Free Survival in Study GFEA-05
Figure 6. Overall Survival in Study GFEA-05
See Table 6 for statistics on 5 and 10 year analyses.

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. 2006; 63:1172-1193.
4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

Epirubicin Hydrochloride Injection, USP is available in glass single-use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths:
NDC 0143-9202-01
NDC 0143-9203-01
Store refrigerated between 2u00baC and 8u00baC (36u00baF and 46u00baF). n
Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15 to 25u00baC). Solution for injection should be used within 24 hours after removal from refrigeration.
Manufactured by
THYMOORGAN PHARMAZIE GmbH,
Schiffgraben 23, 38690 Goslar, Germany
Distributed by
West-Ward Pharmaceuticals
Eatontown, NJ 07724 USA
Revised January 2016
127.207.013/00

Inform patients of the expected adverse effects of epirubicin hydrochloride, including gastrointestinal symptoms (nausea, vomiting, diarrhea, and stomatitis), alopecia and potential neutropenic complications.
Patients should understand that there is a risk of irreversible myocardial damage associated with treatment with epirubicin hydrochloride, as well as a risk of treatment-related leukemia.
Patients should consult their physician if vomiting, dehydration, fever, evidence of infection, symptoms of CHF, or injection-site pain occurs following therapy with epirubicin hydrochloride.
Advise patients that their urine may appear red for 1 to 2 days after administration of epirubicin hydrochloride and that they should not be alarmed.
Because epirubicin hydrochloride may induce chromosomal damage in sperm, advise men undergoing treatment with epirubicin hydrochloride to use effective contraceptive methods. Women treated with epirubicin hydrochloride may develop irreversible amenorrhea, or premature menopause.

u00a0NDC 0143-9202-01
Rx only
EPIRUBICIN HCl INJECTION, USP
50 mg/25 mL
(2 mg/mL)
FOR INTRAVENOUS USE ONLY
Cytotoxic Agent

No data

u00a0NDC 0143-9202-01
Rx only
EPIRUBICIN HCl INJECTION, USP
200 mg/100 mL
(2 mg/mL)
FOR INTRAVENOUS USE ONLY
Cytotoxic Agent

No data

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Epirubicin Hydrochloride (Epirubicin Hydrochloride)

Trade Name : Epirubicin Hydrochloride

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Delivery Process

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Epirubicin Hydrochloride (Epirubicin Hydrochloride)

Trade Name : Epirubicin Hydrochloride

INJECTION

Delivery Process

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"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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