Teriparatid

Name: Clinical-grade Teriparatid - Evidentic GmbH
Price: 203.00 EUR
Availability: InStock

BATCH NUMBER: To be announced

203,00 €

Minimum order quantity: 11

Therapeutic Teriparatid from the original Forsteo® commercial drug

Drug Aliquots On Demand

*Subject to availability and market fluctuations.

Product specifications:

Product Concentration 0,25 mg/mL
Volume per vial 40 µL
Quantity per vial 0,01 mg
Batch Number to be announced
Storage Temperature 2-8 °C / -80 °C

Expiry Date: to be announced

Our products are for research use only. The “therapeutic expiration date” implies expiry date for patient adminstration and is not applicable to the shelf life of the aliquot. Aliquot storage at -86°C ensures fully functional molecules even after the mentioned expiry date

Evidentic offers repackaged finished pharmaceutical products (e.g RMP/RLD). We refer to the repackaged RMP/RLD products synonymously as drug aliquots or aRMP, or short: aliquots.

We offer batches of original drug aliquots in low-binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.

Procurement of original drug products (RMP).

As ‘raw material’ for the production of drug aliquots, Evidentic sources RMP from the European (EU) market. As a licensed pharmaceutical wholesaler, Evidentic is committed to Good Distribution Practice (GDP) compliance with respect to the procurement, storage and shipment of RMP.

Production of drug aliquots from RMP

Drug aliquots are manufactured by repackaging RMP in a qualified laboratory. The aliquotation process is performed under a quality and manufacturing agreement between Evidentic and the contract manufacturer. Repackaging of RMP includes the following steps: opening the secondary and primary RMP containers and transferring the specified volumes of RMP into an Eppendorf 0.5 ml low-binding (or similar) tube. If the RMP is a lyophilized powder and not a highly concentrated solution, reconstitute the RMP according to the original manufacturer’s instructions and then aliquot as a highly concentrated solution.

Labeling of drug aliquots

For identification purposes, drug aliquots are labeled with the date of aliquoting, the original lot number of the RMP, the original expiration date of the RMP, the name of the active ingredient (INN), and a unique identification code.

Storage of drug aliquots

Immediately after aliquoting, drug aliquots are stored at either 2-8 °C or -86 °C for long-term storage. All drug aliquots stored at 2-8 °C are transferred to -86 °C at least two weeks before the expiration date of the original RLD/RMP is reached. Further quality or functional testing are not performed on the drug aliquots.

Target

PTH1

Class of molecule

Hormone

Isotype

Recombinant DNA

Host cells

Produced in E. coli

Prepared from

Forsteo®

Therapeutic Area

Bone diseases

Therapeutic Indications

Postmenopausal Osteoporosis

Mechanism of Action (MoA)

Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Teriparatid (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone. Physiological actions of PTH include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate by the kidney.

Pharmacotherapeutic group

Calcium homeostasis, parathyroid hormones and analogues

List of Excipients

Glacial acetic acid
Sodium acetate (anhydrous)
Mannitol
Metacresol
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

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