Sanzyme
Sanzyme is a pioneering pharmaceutical company specializing in the development and manufacturing of gonadotropins, sex hormones, and specialty probiotics. With over half a century of experience, they are among the first to offer contract manufacturing of human-derived gonadotropins globally. Their mission is to provide high-quality fertility drugs and reproductive health solutions worldwide, leveraging their certifications, extensive capacity, and global regulatory compliance. Sanzyme aims to be accessible to every prospective patient and to expand their footprint through collaborations and innovative manufacturing practices.
Industries
Nr. of Employees
large (251-1000)
Products
Human menopausal gonadotropin (HMG) injectables
HMG (combination of FSH and LH) provided as lyophilized single-dose vials and liquid multi-dose vials for controlled ovarian stimulation.
Follicle stimulating hormone (FSH) injectables
FSH formulations for controlled ovarian stimulation available as lyophilized vials and liquid multi-dose vials.
Human chorionic gonadotropin (hCG) injectables
hCG formulations for ovulation trigger and luteal support available as lyophilized powder and liquid ready-to-use forms across multiple IU strengths.
Progesterone (oral capsules and injections)
Progesterone supplied as oral capsules and intramuscular injection formulations for luteal support and pregnancy maintenance.
Hydroxyprogesterone caproate injectable
Long-acting hydroxyprogesterone caproate injectable formulation intended to reduce risk of preterm birth in specified clinical indications.
Therapeutic probiotic formulations (CKD, nephrolithiasis, GI indications)
Multiple probiotic formulations with specified multi-strain CFU counts offered in capsule and sachet formats for indications such as chronic kidney disease, nephrolithiasis and GI disorders.
Human menopausal gonadotropin (HMG) injectables
HMG (combination of FSH and LH) provided as lyophilized single-dose vials and liquid multi-dose vials for controlled ovarian stimulation.
Follicle stimulating hormone (FSH) injectables
FSH formulations for controlled ovarian stimulation available as lyophilized vials and liquid multi-dose vials.
Human chorionic gonadotropin (hCG) injectables
hCG formulations for ovulation trigger and luteal support available as lyophilized powder and liquid ready-to-use forms across multiple IU strengths.
Progesterone (oral capsules and injections)
Progesterone supplied as oral capsules and intramuscular injection formulations for luteal support and pregnancy maintenance.
Hydroxyprogesterone caproate injectable
Long-acting hydroxyprogesterone caproate injectable formulation intended to reduce risk of preterm birth in specified clinical indications.
Therapeutic probiotic formulations (CKD, nephrolithiasis, GI indications)
Multiple probiotic formulations with specified multi-strain CFU counts offered in capsule and sachet formats for indications such as chronic kidney disease, nephrolithiasis and GI disorders.
Services
Contract manufacturing of biologic gonadotropins
End-to-end manufacturing service covering drug substance extraction and purification, formulation, and finished injectable supply for gonadotropins.
Regulatory support and dossier provision (CTD/eCTD)
Preparation and delivery of CTD/eCTD dossiers to support product registration in international markets.
Probiotic product development and manufacturing
Development and manufacture of multi-strain probiotic formulations with specified CFU counts for therapeutic use.
Sex hormone formulation and supply
Manufacture and formulation of sex hormone products in oral and injectable dosage forms.
Contract manufacturing of biologic gonadotropins
End-to-end manufacturing service covering drug substance extraction and purification, formulation, and finished injectable supply for gonadotropins.
Regulatory support and dossier provision (CTD/eCTD)
Preparation and delivery of CTD/eCTD dossiers to support product registration in international markets.
Probiotic product development and manufacturing
Development and manufacture of multi-strain probiotic formulations with specified CFU counts for therapeutic use.
Sex hormone formulation and supply
Manufacture and formulation of sex hormone products in oral and injectable dosage forms.
Expertise Areas
- Biologics contract manufacturing (CMO)
- Glycoprotein downstream processing and purification
- Injectable formulation development and fill-finish
- Bioanalytical testing and immunoassays
Key Technologies
- Multi-step chromatography for protein purification
- Lyophilization (freeze-drying) for injectable vials
- Liquid multi-dose vial formulation and fill-finish
- Immunoassays and bioanalytical assay platforms