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1. Hpth (1-34)
2. Human Parathyroid Hormone (1-34)
3. Parathar
4. Teriparatide
5. Teriparatide Acetate
1. Parathar
2. Parathyroid Hormone (1-34) (human)
3. 52232-67-4
4. Teriparatida
5. Teriparatidum
6. Teriparatidum [latin]
7. Teriparatida [spanish]
8. Human Parathyroid Hormone (1-34)
9. Human Pth (1-34)
10. Unii-10t9csu89i
11. (1-34)-human Parathormone
12. 1-34-parathormone (human)
13. Parathyroid Hormone (1-34)
14. Mn 10t
15. Hsdb 7367
16. Hpth (1-34)
17. Mn 10-t
18. Teriparatide [usan:inn:ban:jan]
19. Parathyroid Hormone Peptide (1-34)
20. Hpth- (1-34)
21. Zt 034
22. 10t9csu89i
23. Chebi:135983
24. Pth 1-34
25. Akos015994659
26. Hs-2025
Molecular Weight | 4118 g/mol |
---|---|
Molecular Formula | C181H291N55O51S2 |
XLogP3 | -18.7 |
Hydrogen Bond Donor Count | 60 |
Hydrogen Bond Acceptor Count | 62 |
Rotatable Bond Count | 146 |
Exact Mass | 4116.1342973 g/mol |
Monoisotopic Mass | 4115.1309424 g/mol |
Topological Polar Surface Area | 1800 Ų |
Heavy Atom Count | 289 |
Formal Charge | 0 |
Complexity | 9740 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 34 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Bone Density Conservation Agents
National Library of Medicine, SIS; ChemIDplus Record for Teriparatide (52232-67-4), MESH Heading. Available from, as of March 15, 2006: https://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
Forteo is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. These include women with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment. In postmenopausal women with osteoporosis, forteo increases BMD and reduces the risk of vertebral and nonvertebral fractures.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1741
Forteo is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. In men with primary or hypogonadal osteoporosis, forteo increases BMD. The effects of forteo on risk for fracture in men have not been studied.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1741
In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20-ug dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, teriparatide should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk. Teriparatide should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior external beam or implant radiation therapy involving the skeleton).
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1739
Adverse effects reported to have been increased by teriparatide treatment in clinical trials included leg cramps and dizziness. Adverse effects reported in at least 2% of patients receiving teriparatide and more frequently than with placebo but without attribution of causality include pain, arthralgia, rhinitis, asthenia, nausea, dizziness, headache, hypertension, increased cough, pharyngitis, constipation, dyspepsia, diarrhea, rash, insomnia, depression, pneumonia, vertigo, dyspnea, neck pain, vomiting, syncope, leg cramps, angina pectoris, GI disorder, sweating, or tooth disorder.
McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3088
In short-term clinical pharmacology studies with teriparatide, transient episodes of symptomatic orthostatic hypotension were observed infrequently. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, it was relieved by placing the person in a reclining position, and it did not preclude continued treatment.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1741
The safety and efficacy of forteo have not been evaluated beyond 2 years of treatment. Consequently, use of the drug for more than 2 years is not recommended. In clinical trials, the frequency of urolithiasis was similar in patients treated with forteo and placebo. However, forteo has not been studied in patients with active urolithiasis. If active urolithiasis or pre-existing hypercalciuria are suspected, measurement of urinary calcium excretion should be considered. Forteo should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1741
For more Drug Warnings (Complete) data for TERIPARATIDE (13 total), please visit the HSDB record page.
Bone Density Conservation Agents
Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)
Calcium-Regulating Hormones and Agents
Hormones and molecules with calcium-regulating hormone-like actions that modulate OSTEOLYSIS and other extra-skeletal activities to maintain calcium homeostasis. (See all compounds classified as Calcium-Regulating Hormones and Agents.)
Systemic clearance of teriparatide (approximately 62 L/hr in women and 94 L/hr in men) exceeds the rate of normal liver plasma flow, consistent with both hepatic and extra-hepatic clearance. Volume of distribution, following intravenous injection, is approximately 0.12 L/kg. Intersubject variability in systemic clearance and volume of distribution is 25% to 50%.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1739
Teriparatide is extensively absorbed after subcutaneous injection; the absolute bioavailability is approximately 95% based on pooled data from 20-, 40-, and 80-ug doses. The rates of absorption and elimination are rapid. The peptide reaches peak serum concentrations about 30 minutes after subcutaneous injection of a 20-ug dose and declines to non-quantifiable concentrations within 3 hours.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1739
The half-life of teriparatide in serum is 5 minutes when administered by intravenous injection and approximately 1 hour when administered by subcutaneous injection. The longer half-life following subcutaneous administration reflects the time required for absorption from the injection site.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1739
The skeletal effects of teriparatide depend upon the pattern of systemic exposure. Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide are manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1739
Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors. Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues.
Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 1739
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8509
Submission : 1990-04-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-29
DMF Number : 38923
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-09
Pay. Date : 2019-05-17
DMF Number : 33857
Submission : 2019-05-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-19
Pay. Date : 2018-08-13
DMF Number : 33079
Submission : 2018-08-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-22
Pay. Date : 2019-06-17
DMF Number : 32144
Submission : 2019-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34388
Submission : 2019-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-21
Pay. Date : 2021-12-22
DMF Number : 36502
Submission : 2021-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34713
Submission : 2020-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-24
Pay. Date : 2019-05-16
DMF Number : 33210
Submission : 2019-01-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-03
Pay. Date : 2021-02-05
DMF Number : 35583
Submission : 2021-02-22
Status : Active
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info :
Registration Country : Switzerland
Brand Name : Sondelbay
Dosage Form : Inj L?s
Dosage Strength : 20mcg/80mcl,ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : FORSTEO
Dosage Form : Solution For Injection In Pre-Filled Pen
Dosage Strength : 20 mcg/80 mcl
Packaging : 1 UNIT 20 MCG/80 MCL - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Forsteo
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 20 microg/80 microliter
Packaging : Pre-filled pen 1 28doses
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Terrosa Start
Dosage Form : Solution for injection
Dosage Strength : 20 microg/80 microliter
Packaging : Sylinderampulle 1 28doses, pcs
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Terrosa
Dosage Form : Solution for injection
Dosage Strength : 20 microg/80 microliter
Packaging : Sylinderampulle 3 28doses
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Terrosa
Dosage Form : Inj Solution
Dosage Strength : 250mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : OSEFFYL
Dosage Form : Solution For Injection In Pre-Filled Pen
Dosage Strength : 20 micrograms/80 microliters
Packaging : 1 UNIT 20 MCG/80 MCL - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Teriparatide-Mepha
Dosage Form : Inj Solution
Dosage Strength : 250mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Norway
Brand Name : Forsteo
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 20 microg/80 microliter
Packaging : Pre-filled pen 1 28doses
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Movymia Start
Dosage Form : Solution for injection
Dosage Strength : 20 microg/80 microliter
Packaging : Sylinderampulle 1 28doses, pcs
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Global Sales Information
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Teriparatide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teriparatide, including repackagers and relabelers. The FDA regulates Teriparatide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teriparatide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Teriparatide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teriparatide supplier is an individual or a company that provides Teriparatide active pharmaceutical ingredient (API) or Teriparatide finished formulations upon request. The Teriparatide suppliers may include Teriparatide API manufacturers, exporters, distributors and traders.
click here to find a list of Teriparatide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Teriparatide DMF (Drug Master File) is a document detailing the whole manufacturing process of Teriparatide active pharmaceutical ingredient (API) in detail. Different forms of Teriparatide DMFs exist exist since differing nations have different regulations, such as Teriparatide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teriparatide DMF submitted to regulatory agencies in the US is known as a USDMF. Teriparatide USDMF includes data on Teriparatide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teriparatide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teriparatide suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Teriparatide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Teriparatide API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Teriparatide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Teriparatide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Teriparatide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Teriparatide suppliers with NDC on PharmaCompass.
Teriparatide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Teriparatide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Teriparatide GMP manufacturer or Teriparatide GMP API supplier for your needs.
A Teriparatide CoA (Certificate of Analysis) is a formal document that attests to Teriparatide's compliance with Teriparatide specifications and serves as a tool for batch-level quality control.
Teriparatide CoA mostly includes findings from lab analyses of a specific batch. For each Teriparatide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Teriparatide may be tested according to a variety of international standards, such as European Pharmacopoeia (Teriparatide EP), Teriparatide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Teriparatide USP).
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