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PRODUCTS

 

Sanzyme Ltd., was formed on the 5th August 1969 as Unl-Sankyo limited, the first ever Indo-Japanese joint venture with Sankyo Company limited (now known as Daiichi Sankyo, Japan) to manufacture enzymes and gonadotropins with the technology transferred from Sankyo & export to parent company. Thus lead the way as a pioneer in gonadotropins and probiotics in India.

 

PUBERGEN
[human chorionic gonadotropin for injection]


hCG [Human Chorionic Gonadotropin] obtained from natural sources is aptly termed as the surrogate LH [Lutenising Hormone] for triggering of ovulation and maintenance of pregnancy.

Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta sub-unit. The alpha sub-unit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence.

hCG, produced by specialized cells known as syncytiotrophoblast cells or more specifically villous syncytiotrophoblast cells as pregnancy progresses . This is the molecules that promotes progesterone production and other important biological functions during the course of pregnancy. Today, the function of hCG is still marked as being progesterone promotion in most medical student text books, but we now know now that hCG has numerous other important placental, uterine and fetal functions in pregnancy. From the time of implantation, hCG produced by trophoblast cells take over corpus luteal progesterone production from luteinizing hormone (LH), acting on a joint hCG/LH receptor. This continues for approximately 3 to 4 weeks. After that time, there are sufficient syncytiotrophoblast cells in the placenta to take over progesterone production from corpus luteal cells.

Currently hCG is used for triggering of ovulation, maintenance of high risk pregnancies and as an effective agent for preterm labour. Depending on the clinical needs, dosages ranging from 5000 to 10000 IU of hCG have been used for triggering ovulation, while the dosage form of 7500 IU has been exclusively used for women with higher BMI.

Lower doses of hCG 500 IU to 2000 IU, are being used for treating male infertility disorders ranging from hypogonadotropic hypogonadism , stimulating endogenous testosterone production.


PUBERGEN [Human Chorionic Gonadotropin]
- 500 [ [Highly Purified Human Chorionic Gonadotropin]
- 1000/2000/5000
- 7500 [Highly Purified Human Chorionic Gonadotropin] and
- 10000 IU

ENDOGEN
[Highly Purified Follicle-Stimulating Hormone for Injection]


Endogen, belongs to a group known as urofollitropin and is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from natural sources. Human FSH consists of two non-covalently linked glycoproteins designated as the α - and β - subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β- subunit has 111 amino acids of which two are modified by attachment of carbohydrates.

Endogen (urofollitropin injection) is a sterile, lyophilized powder intended for subcutaneous (SC) or intramuscular (IM) injection after reconstitution with sterile 0.9%

Ovulation Induction

Endogen injection is administered SC / IM , is indicated for ovulation induction in infertile patients who have previously received agonists or antagonists for pituitary suppression.

Multifollicular Development during ART
Endogen injection is administered SC/IM is used controlled ovarian stimulation during ART cycles in patients who have previously received who have previously received agonists or antagonists for pituitary suppression.

Endogen administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with Endogen in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Spermatogenesis in Males
Endogen administered SC/IM is used to stimulate spermatogenesis in males along with human chorionic gonadotropin

ENDOGEN [Highly Purified Follicle Stimulating Hormone]
- 75 IU
- 150 IU

GYNOGEN
[Highly Purified Human Menopausal Gonadotropin for Injection]


Gynogen belongs to a group known as Menotropins and is a preparation of gonadotropins, extracted from natural sources , which has undergone additional steps for purification. Each vial of Gynogen contains 75 International Units (IU) of follicle-stimulating hormone (FSH) activity and 75 IU of luteinizing hormone (LH) activity and 150 International Units (IU) of follicle-stimulating hormone (FSH) activity and 150 IU of luteinizing hormone (LH) activity.Both FSH and LH are glycoproteins that are water soluble.

Follicular Development
Gynogen is administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. In order to produce final follicular maturation and ovulation in the absence of an endogenous LH surge, hCG must be administered following Gynogen treatment, at a time when patient monitoring indicates sufficient follicular development has occurred. Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval.

Spermatogenesis in Males
In males for improving sperm count, with no primary hypogonadism, Gynogen administered alone or in low doses in conjunction with low doses of human chorionic gonadotropin, have shown improvement in sperm counts of males treated.


GYNOGEN [Highly Purified Menotropin]

- 75 IU [75IU FSH+75 IU LH]
- 150 IU [150 IU FSH+150 IU LH]

All the gonadotropins, hCG,FSH and HMG are manufactured using a specialized proprietary trademarked process known as “LYGOTECH”.This process involves using the right temperature, pressure and removal of water content from the formulation to ensure:

1. The protein/s that are present in the formulation are not denatured during manufacturing process
2. Excess moisture content is removed to ensure the cake formed during manufactured is easily soluble during reconstitution with diluent provided and
3. The potency or the strength mentioned on the label is maintained till the end of the shelf-life

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