About GenBioPro

Here to Help

In the US, medically unnecessary restrictions and political interference result in medical abortion being inaccessible for far too many women. Limitations on abortion care training, high costs, laws targeting abortion care providers, and disinformation are just some of the barriers to abortion care.

Our company was founded on the belief that all people – regardless of income, gender, race, or geography – have a right to reproductive health care, including access to medical abortion. From driving down medication costs to promoting accurate information about abortion, our mission is to deliver affordable, effective products for people seeking abortion care.

We promote personal dignity, access to medical evidence, self-determination, and high-quality health care for all.

GenBioPro is helping to advance medical research to improve women’s health. We are committed to eliminating barriers and to supporting the community of providers, patients, and advocates working to ensure universal access to reproductive health care.

genbiopro-about-here-to-help

Already at Work for You

We’ve been working quietly for both patients and providers since 2012. Our market entry and competitive presence have already triggered changes that have benefitted the community. We successfully fought for the approval and commercialization of the first FDA-approved generic 200mg mifepristone tablet. Going forward, we’ll continue to innovate and work for the reproductive health community at large.

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We Believe

  • Providers have had limited options for quality, reasonably-priced, family-planning products that millions of their patients depend on. For example, until our FDA approval, there was only one option within the US for mifepristone.
  • Over-regulation of medical abortion forces doctors to spend unnecessary time and resources to prescribe and provide this care to their patients.
  • The introduction of generic mifepristone to the market will help stabilize supply and satisfy the rising demand among patients for medical abortion, which has steadily increased since its introduction in 2000.
  • Our understanding of the pharmaceutical industry’s complex regulatory processes is key to identifying opportunities to increase access to safe, affordable, reproductive health care.

Building Trust: Step by Step

Evidenced by our work to date, you can trust GenBioPro to continue to develop solutions that break new ground, bring advantage to both providers and patients, and advocate for long-term change. We are working towards a world that ensures access to safe, affordable, reproductive health care – including medical abortion – is within reach for everyone.

Important Safety Information

Mifepristone tablets, 200mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.


IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. No causal relationship between the use of mifepristone and misoprostol and these events has been established.
    • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.
    • Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.
  • Because of the risks of serious complications described above, mifepristone is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.
  • Before prescribing mifepristone, inform the patient about these risks. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.
  • Advise the patient to take the Medication Guide with her if she visits an emergency room or another healthcare provider who did not prescribe mifepristone, so that provider knows that she is undergoing a medical abortion.

 

Contraindications 

  • Administration of mifepristone and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:
    • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
    • Chronic adrenal failure (risk of acute renal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
    • History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
    • Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
    • Inherited porphyrias (risk of worsening or of precipitation of attacks)
  • Use of mifepristone and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, mifepristone may be used.

 

Warnings and Precautions

Infection and Sepsis

  • As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of mifepristone. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
  • A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

 

Uterine Bleeding

  • Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
  • Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days.  Up to 8% of all subjects may experience some type of bleeding for 30 days or more.  In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
  • Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in women who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.

 

Mifepristone REMS Program

Mifepristone is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program, because of the risks of serious complications. Notable requirements of the mifepristone REMS Program include the following:

  • Prescribers must be certified with the program by completing the Prescriber Agreement Form.
  • Patients must sign a Patient Agreement Form.
  • Mifepristone must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

 

Ectopic Pregnancy

Mifepristone is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

 

Rhesus Immunization

The use of mifepristone is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

 

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.

 

For additional information about mifepristone, click for the Full Prescribing Information, including Boxed Warning.

 

Important Safety Information
Show More

Mifepristone tablets, 200mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. No causal relationship between the use of mifepristone and misoprostol and these events has been established.
    • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.
    • Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.
  • Because of the risks of serious complications described above, mifepristone is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.
  • Before prescribing mifepristone, inform the patient about these risks. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.
  • Advise the patient to take the Medication Guide with her if she visits an emergency room or another healthcare provider who did not prescribe mifepristone, so that provider knows that she is undergoing a medical abortion.

 

Contraindications 

  • Administration of mifepristone and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:
    • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
    • Chronic adrenal failure (risk of acute renal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
    • History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
    • Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
    • Inherited porphyrias (risk of worsening or of precipitation of attacks)
  • Use of mifepristone and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, mifepristone may be used.

 

Warnings and Precautions

Infection and Sepsis

  • As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of mifepristone. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
  • A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

 

Uterine Bleeding

  • Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
  • Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days.  Up to 8% of all subjects may experience some type of bleeding for 30 days or more.  In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
  • Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in women who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.

 

Mifepristone REMS Program

Mifepristone is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program, because of the risks of serious complications. Notable requirements of the mifepristone REMS Program include the following:

  • Prescribers must be certified with the program by completing the Prescriber Agreement Form.
  • Patients must sign a Patient Agreement Form.
  • Mifepristone must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

 

Ectopic Pregnancy

Mifepristone is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

 

Rhesus Immunization

The use of mifepristone is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

 

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.

 

For additional information about mifepristone, click for the Full Prescribing Information, including Boxed Warning.