Fostimon Uses

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What is Fostimon?

Fostimon is a man-made form of a hormone that occurs naturally in the body. This hormone regulates ovulation, the growth and development of eggs in a woman's ovaries.

Fostimon is used to treat infertility in women who cannot ovulate and do not have primary ovarian failure.

Fostimon is also used to stimulate sperm production in men.

Fostimon is often used together with another medication called human chorionic gonadotropin (hCG).

Fostimon may also be used for purposes not listed in this medication guide.

Fostimon indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.


Fostimon® (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Fostimon® is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.

Selection of Patients

  1. Before treatment with Fostimon® is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Fostimon® only if enrolled in an in vitro fertilization program.
  2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
  3. Appropriate evaluation should be performed to exclude pregnancy.
  4. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Fostimon® therapy.
  5. Evaluation of the partner's fertility potential should be included in the initial evaluation.


Fostimon® (follitropin alfa for injection) is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Selection of Patients

  1. Before treatment with Fostimon® is instituted for azoospermia, a thorough medical and endocrinologic evaluation must be performed.
  2. Hypogonadotropic hypogonadism should be confirmed, and primary testicular failure should be excluded by the determination of gonadotropin levels.
  3. Prior to Fostimon® therapy for azoospermia in patients with hypogonadotropic hypogonadism, serum testosterone levels should be normalized.

How should I use Fostimon?

Use Fostimon as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Fostimon.

Uses of Fostimon in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Fostimon or FSH is used to treat problems of infertility.

Fostimon description

Vial: Each vial contains follitropin α*, 5.5 mcg and 77 mcg, equivalent to 75 IU, and 1050 IU, respectively.

Each mL of reconstituted solution contains 75 IU for Fostimon 75 IU and 600 IU for Fostimon 1050 IU.

Each vial also contains the following excipients: Powder: Sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide; and also methionine and polysorbate 20 for Fostimon 75 IU. Solvent: Water for injections. Fostimon 1050 IU also contains benzyl alcohol.

The pH of the reconstituted solution is 6.5-7.5.

Pre-Filled Pen: Each mL of the solution contains follitropin α, 600 IU (equivalent to 44 mcg). Each pre-filled multidose pen delivers follitropin α 300 IU (equivalent to 22 mcg), 450 IU (equivalent to 33 mcg) and 900 IU (equivalent to 66 mcg) in 0.5 mL, 0.75 mL and 1.5 mL, respectively.

Each pre-filled pen also contains the following excipients: Poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.

The pH of the solution is 6.7-7.3.

Sodium Content: Each vial/pre-filled pen contains >1 mmol sodium (2.3 mg)/dose ie, essentially "sodium free".

*Recombinant human Fostimon (r-hFSH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Fostimon dosage


Treatment with Fostimon should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.

Pre-Filled Pen: Patients must be provided with the correct number of pens for their treatment course and educated to use the proper injection techniques.

The dose recommendations given for Fostimon are those in use for urinary Fostimon (FSH). Clinical assessment of Fostimon indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products. It is advised to adhere to the recommended starting doses indicated as follows.

Comparative clinical studies have shown that on average patients require a lower cumulative dose and shorter treatment duration with Fostimon compared with urinary FSH. Therefore, it is considered appropriate to give a lower total dose of Fostimon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.

Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of Fostimon (pre-filled pen/vial 1050 IU/1.75 mL only).

The following table states the volume to be administered, to deliver the prescribed dose (Fostimon 1050 IU/1.75 mL only):

The next injection should be done at the same time the next day.

Women with Anovulation [Including Polycystic Ovarian Syndrome (PCOS)]: Fostimon may be given as a course of daily injections. In menstruating women, treatment should commence within the first 7 days of the menstrual cycle.

A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7- or preferably 14-day intervals if necessary, to obtain an adequate but not excessive response. Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or oestrogen secretion. The maximal daily dose is usually not higher than 225 IU FSH. If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should undergo further evaluation. After which, the patient may recommence treatment at a higher starting dose than in the abandoned cycle.

When an optimal response is obtained, a single injection of recombinant human choriogonadotropin α (r-hCG) 250 mcg or hGC 5000 up to 10,000 IU should be administered 24-48 hrs after the last Fostimon injection. The patient is recommended to have coitus on the day of, and the day following hCG administration. Alternatively, intrauterine insemination (IUI) may be performed.

If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment should recommence in the next cycle at a dose lower than that of the previous cycle.

Women Undergoing Ovarian Stimulation for Multiple Follicular Development Prior to In Vitro Fertilisation (IVF) or Other Assisted Reproductive Technologies: A commonly used regimen for superovulation involves the administration of 150-225 IU of Fostimon daily, commencing on days 2 or 3 of the cycle. Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily. In general, adequate follicular development is achieved on average by the 10th day of treatment (range 5-20 days).

A single injection of r-hCG 250 mcg or hCG 5000 up to 10,000 IU hCG is administered 24-48 hrs after the last Fostimon injection to induce final follicular maturation.

Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous luteinising hormone (LH) surge and to control tonic levels of LH. In a commonly used protocol, Fostimon is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved. For example, following 2 weeks of treatment with an agonist, Fostimon 150-225 IU are administered for the first 7 days. The dose is then adjusted according to the ovarian response.

Overall experience with IVF indicates that in general, the treatment success rate remains stable during the first 4 attempts and gradually declines thereafter.

Special Populations: Renal or Hepatic Impairment: Safety, efficacy and pharmacokinetics of Fostimon in patients with renal or hepatic impairment have not been established.

Children: There is no relevant use of Fostimon in the paediatric population.

Elderly: There is no relevant use of Fostimon in the elderly population. Safety and effectiveness of Fostimon in elderly patients have not been established.

Administration: Vial: Fostimon is intended for SC administration. The 1st injection of Fostimon should be performed under direct medical supervision. Self-administration of Fostimon should only be performed by patients who are well motivated, adequately trained and have access to expert advice. For instructions on the reconstitution and administration of Fostimon and solvent for solution for injection.

Fostimon pre-filled pen with multidose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation.

Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days. Individual reconstituted vials should be for single patient use only.

Fostimon interactions

See also:
What other drugs will affect Fostimon?


Concomitant use of Fostimon with other medicinal products used to stimulate ovulation [eg, human chorionic gonadotropin (hCG), clomiphene citrate] may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dosage of Fostimon needed to elicit an adequate ovarian response. No other clinically significant medicinal product interaction has been reported during Fostimon therapy.

Vial 75 IU: Fostimon must not be mixed with other medicinal products, in the same injection, except lutropin α for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.

Incompatibilities: Vial: In the absence of compatibility studies, it must not be mixed with other medicinal products except those mentioned in Caution for Usage.

Pre-Filled Pen: Not applicable.

Fostimon side effects

See also:
What are the possible side effects of Fostimon?


The safety of Fostimon® was examined in four clinical studies that enrolled 691 patients into two studies for ovulation induction (454 patients) and two studies for ART (237 patients).

Adverse events occurring in more than 10% of patients were headache, ovarian cyst, nausea, and upper respiratory tract infection in the U.S. ovulation induction study and headache in the U.S. ART study. Adverse events (without regard to causality assessment) occurring in at least 2% of patients are listed in Table 13 and Table 14.

Table 13: US Controlled Trial in Ovulation Induction, Study 5727
Body System

Preferred Term


Patients (%) Experiencing Events

Treatment cycles = 288*



Patients (%) Experiencing Events

Treatment cycles = 277*

n= 114

up to 3 cycles of therapy
Severe = 0.8% of 118 patients in Study 5727
Reproductive, Female
Intermenstrual Bleeding 9.3% 4.4%
Breast Pain Female 4.2% 6.1%
Ovarian Hyperstimulation† 6.8% 3.5%
Dysmenorrhea 2.5% 6.1%
Ovarian Disorder 1.7% 2.6%
Cervix Lesion 2.5% 0.9%
Menstrual Disorder 2.5% 0.9%
Gastro-intestinal System
Abdominal Pain 9.3% 12.3%
Nausea 13.6% 3.5%
Flatulence 6.8% 8.8%
Diarrhea 7.6% 3.5%
Vomiting 2.5% 2.6%
Dyspepsia 1.7% 3.5%
Central and Peripheral Nervous System
Headache 22.0% 20.2%
Dizziness 2.5% 0.0%
Ovarian Cyst 15.3% 28.9%
Body as a Whole- General
Pain 5.9% 6.1%
Back Pain 5.1% 1.8%
Influenza-like Symptoms 4.2% 2.6%
Fever 4.2% 1.8%
Respiratory System
Upper Respiratory Tract Infection 11.9% 7.9%
Sinusitis 5.1% 5.3%
Pharyngitis 2.5% 3.5%
Coughing 1.7% 2.6%
Rhinitis 0.8% 2.6%
Skin and Appendages
Acne 4.2% 2.6%
Emotional Lability 5.1% 2.6%
Urinary System
Urinary Tract Infection 1.7% 4.4%
Resistance Mechanism
Moniliasis Genital 2.5% 0.9%
Application Site
Injection Site Pain 2.5% 0.9%

Additional adverse events not listed in Table 13 that occurred in 1 to 2% of Fostimon® treated patients in the US ovulation induction study included the following: leukorrhea, vaginal hemorrhage, migraine, fatigue, asthma, nervousness, somnolence, and hypotension.

Table 14: US Controlled Trial in ART, Study 5533
Body System

Preferred Term


Patients (%) Experiencing Events



Patients (%) Experiencing Events

n= 61

Reproductive, Female
Intermenstrual Bleeding 3.6% 5.2%
Leukorrhea 1.7% 3.4%
Vaginal Hemorrhage 3.6% 3.4%
Gastro-intestinal System
Nausea 5.4% 1.7%
Flatulence 3.6% 0.0%
Central and Peripheral Nervous System
Headache 12.5% 3.4%
Body as a Whole- General
Abdominal Pain 8.9% 3.4%
Pelvic Pain Female 7.1% 1.7%
Respiratory System
Upper Respiratory Tract Infection 3.6% 1.7%
Metabolic and Nutritional
Weight Increase 3.6% 0.0%

Additional adverse events not listed in Table 14 that occurred in 1 to 2% of Fostimon® treated patients in the U.S. Assisted Reproductive Technology (ART) study included the following: D&C following delivery or abortion, dysmenorrhea, vaginal hemorrhage, diarrhea, tooth disorder, vomiting, dizziness, paraesthesia, abdomen enlarged, chest pain, fatigue, dyspnea, anorexia, anxiety, somnolence, injection site inflammation, injection site reaction, pruritus, pruritus genital, myalgia, thirst, and palpitation.

Two additional clinical studies (for ovulation induction and ART, respectively) were conducted in Europe. The safety profiles from these two studies were comparable to that of the data presented above.

Fostimon® Multi-Dose was examined in twenty-five healthy volunteers who received 300 IU each of Fostimon® from single- dose ampules and multi-dose vials. Overall, both presentations were well tolerated and local tolerability between the two groups was comparable. Injection site inspections revealed very rare local reactions (mild redness in one patient after single-dose injection and mild bruising in two subjects after multi-dose injection). Subjective assessments indicated minimal or mild transient pain in two and five subjects who received Fostimon® single-dose and Fostimon® multi-dose, respectively.

The following medical events have been reported subsequent to pregnancies resulting from gonadotropins in controlled clinical studies:

  1. Spontaneous Abortion
  2. Ectopic Pregnancy
  3. Premature Labor
  4. Postpartum Fever
  5. Congenital Abnormalities

Two incidents of congenital cardiac malformations have been reported in children born following pregnancies resulting from treatment with Fostimon® and hCG in Fostimon® clinical studies 5642 and 5727. In addition, a pregnancy occurring in study 5533 following treatment with Fostimon® and hCG was complicated by apparent failure of intrauterine growth and terminated for a suspected syndrome of congenital abnormalities. No specific diagnosis was made. The incidence does not exceed that found in the general population.

The following adverse reactions have been previously reported during menotropin therapy:

  1. Pulmonary and vascular complications,
  2. Adnexal torsion (as a complication of ovarian enlargement),
  3. Mild to moderate ovarian enlargement,
  4. Hemoperitoneum

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.


The safety of Fostimon® was examined in 3 clinical studies that enrolled 72 patients for induction of spermatogenesis and fertility of whom 56 patients received Fostimon®. One hundred and twenty-three adverse events, including 7 serious events, were reported in 34 of the 56 patients during Fostimon® treatment.

In Study 5844, 21 adverse events, including 4 serious adverse events, were reported by 14 of the 26 patients (53.8%) treated with Fostimon®. Events occurring in more than one patient were varicocele (4) and injection site reactions (4). The 4 serious adverse events were testicular surgery for cryptorchidism, which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection.

In Study 6410, 3 adverse events were reported in 2 of the 8 patients (24%) treated with Fostimon®. One serious adverse event was reported, surgery for gynecomastia which existed at baseline.

In the interim analysis of Study 6793, 18 of 22 patients (81.8%) reported a total of 99 adverse events during Fostimon® treatment. The most common events of possible, probable, or definite relationship to study drug therapy occurring in more than 2 patients were: acne (25 events in 13 patients; 59% of patients); breast pain (4 events in 3 patients; 13.6% of patients); and fatigue, gynecomastia, and injection site pain (each of which was reported as 2 events by 2 patients; 9.1% of patients). Two serious adverse events (hospitalization for drug abuse and depression) were reported by a single patient in the interim analysis.

A total of 12,026 injections of Fostimon® were administered by the 56 patients who received Fostimon® in Studies 5844, 6410, and 6793 combined. The injections were well-tolerated, with no or mild reactions (redness, swelling, bruising and itching) reported by patients for 93.3% of injections. Moderate and severe reactions, consisting primarily of pain, were reported for 4.8% of injections, and no self-assessment was available for 1.9% of injections.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been reported during postmarketing use of Fostimon®. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to Fostimon®, can not be reliably determined.

Body as a Whole - General: Hypersensitivity reactions including anaphylactoid reactions.

Respiratory System: asthma

Fostimon contraindications

See also:
What is the most important information I should know about Fostimon?

Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive Fostimon.

Fostimon is not effective in women with primary ovarian failure or in men with primary testicular failure.

You should not use this medicine if you are allergic to Fostimon, neomycin (Mycifradin, Neo-Fradin) or streptomycin, or if you have an untreated or uncontrolled endocrine disorder (thyroid, pituitary gland, or adrenal gland), heavy or abnormal vaginal bleeding that has not been checked by a doctor, an ovarian cyst, or cancer of the breast, ovary, uterus, or testicle.

Before using Fostimon, tell your doctor if you have polycystic ovary disease, asthma, or a history of stroke or blood clot.

You should not breast-feed while you are using Fostimon.

Avoid having sex and call your doctor right away if you have any of the following symptoms of a fluid buildup in your stomach or chest area: severe pain in your lower stomach, nausea, vomiting, diarrhea, bloating, feeling short of breath, swelling or weight gain, or urinating less than usual.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

Active ingredient matches for Fostimon:

Follicle Stimulating Hormone in Argentina, Austria, Bahrain, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, France, Hong Kong, Hungary, Israel, Italy, Luxembourg, Mexico, Netherlands, Norway, Oman, Poland, Serbia, Sweden, Switzerland, Turkey, United Kingdom, Vietnam.

Fsh in Hongkong.

Urofollitropin in United Kingdom.

Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Urofollitropin 75 IU / ml
Injectable; Injection; Urofollitropin 150 IU / ml
Fostimon 75 IU/1 mL x 1 Bottle
Fostimon 150 IU/1 mL x 1 Bottle in 5 Box small trong Box lГґГ№n
Fostimon 75 IU/1 mL x 1 Box 1 Bottle
Fostimon 150 IU/1 mL x 1 Box 1 Bottle

List of Fostimon substitutes (brand and generic names):

FOSTIREL 1200IU INJECTION 1 vial / 1 injection each (Reliance Life Sciences)$ 269.84
FOSTIREL 300IU INJECTION 1 vial / 1 injection each (Reliance Life Sciences)$ 48.57
Fostirel 300IU Injection (Reliance Life Sciences)$ 48.57
FSHSP 150 IU INJECTION 1 vial / 1 injection each (Samarth Life Sciences Pvt Ltd)$ 13.49
Fshsp 150IU Injection (Samarth Life Sciences Pvt Ltd)$ 13.49
FTROP 150MG INJECTION 1 vial / 1 injection each (Shreya Life Sciences Pvt Ltd)$ 23.81
FTROP 75MG INJECTION 1 vial / 1 ML injection each (Shreya Life Sciences Pvt Ltd)$ 12.70
Ftrop 150IU Injection (Shreya Life Sciences Pvt Ltd)$ 23.81
Ftrop 75IU Injection (Shreya Life Sciences Pvt Ltd)$ 12.70
Injectable; Injection; Follitropin Alfa 37.5 IU (PT. Merck Tbk)
Injectable; Injection; Follitropin Alfa 75 IU (PT. Merck Tbk)
Injectable; Injection; Follitropin Alfa 150 IU (PT. Merck Tbk)
Injectable; Injection; Follitropin Alfa 300 IU / 0.5 ml (PT. Merck Tbk)
Injectable; Injection; Follitropin Alfa 450 IU / 1.75 ml (PT. Merck Tbk)
Injectable; Injection; Follitropin Alfa 900 IU / 1.5 ml (PT. Merck Tbk)
Injectable; Injection; Follitropin Alfa 1050 IU / 1.75 ml (PT. Merck Tbk)
0.5 milliliter in 1 cartridge (PT. Merck Tbk)
0.75 milliliter in 1 cartridge (PT. Merck Tbk)
1.5 milliliter in 1 cartridge (PT. Merck Tbk)
Gonal-F 75 IU x 1 Bottle thuoГЎc in 1 Bottle dung mobi pha tieГўm (PT. Merck Tbk)
Gonal-F 75 IU x 1 BuГ№t tieГўm pha saГјn 300 IU/0.5 mL x Box 1 buГ№t tieГўm in 5 kim tieГўm (PT. Merck Tbk)
Gonal-F 75 IU x 450 IU/0.75 mL x Box 1 buГ№t tieГўm in 7 kim tieГўm (PT. Merck Tbk)
Gonal-f / amp 5.5 mcg x 1's (PT. Merck Tbk)$ 64.71
Gonal-f 300 IU x 1's (PT. Merck Tbk)$ 270.69
Gonal-f 450 IU x 1's (PT. Merck Tbk)$ 382.40
Gonal-f 900 IU x 1's (PT. Merck Tbk)$ 803.05


The results of a survey conducted on for Fostimon are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fostimon. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported useful

Was the Fostimon drug useful in terms of decreasing the symptom or the disease?
According to the reports released by website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.

1 consumer reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by website users about whether the Fostimon drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.

1 consumer reported time for results

To what extent do I have to use Fostimon before I begin to see changes in my health conditions?
As part of the reports released by website users, it takes 3 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Fostimon. To get the time effectiveness of using Fostimon drug by other patients, please click here.
3 month1

15 consumers reported age


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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