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Also known as: Parathar, Parathyroid hormone (1-34) (human), 52232-67-4, Teriparatida, Teriparatidum, Teriparatidum [latin]
Molecular Formula
C181H291N55O51S2
Molecular Weight
4118  g/mol
InChI Key
OGBMKVWORPGQRR-UMXFMPSGSA-N

Teriparatide
A polypeptide that consists of the 1-34 amino-acid fragment of human PARATHYROID HORMONE, the biologically active N-terminal region. The acetate form is given by intravenous infusion in the differential diagnosis of HYPOPARATHYROIDISM and PSEUDOHYPOPARATHYROIDISM. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
1 2D Structure

Teriparatide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S)-4-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S,3S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-3-hydroxypropanoyl]amino]-3-methylbutanoyl]amino]-3-hydroxypropanoyl]amino]-4-carboxybutanoyl]amino]-3-methylpentanoyl]amino]-5-oxopentanoyl]amino]-4-methylpentanoyl]amino]-4-methylsulfanylbutanoyl]amino]-3-(1H-imidazol-4-yl)propanoyl]amino]-4-oxobutanoyl]amino]-4-methylpentanoyl]amino]acetyl]amino]hexanoyl]amino]-3-(1H-imidazol-4-yl)propanoyl]amino]-4-methylpentanoyl]amino]-4-oxobutanoyl]amino]-3-hydroxypropanoyl]amino]-4-methylsulfanylbutanoyl]amino]-5-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(2S)-6-amino-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(1S)-1-carboxy-2-phenylethyl]amino]-1,4-dioxobutan-2-yl]amino]-3-(1H-imidazol-4-yl)-1-oxopropan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-3-carboxy-1-oxopropan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxohexan-2-yl]amino]-1-oxohexan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-5-oxopentanoic acid
2.1.2 InChI
InChI=1S/C181H291N55O51S2/c1-21-96(18)146(236-160(267)114(48-53-141(250)251)212-174(281)132(84-239)232-177(284)143(93(12)13)233-147(254)103(185)82-237)178(285)216-111(45-50-134(187)241)155(262)219-119(65-90(6)7)163(270)213-116(55-62-289-20)158(265)224-124(71-100-79-196-86-203-100)167(274)226-126(73-135(188)242)169(276)217-117(63-88(2)3)148(255)201-81-138(245)205-105(39-27-30-56-182)149(256)223-123(70-99-78-195-85-202-99)166(273)221-121(67-92(10)11)164(271)225-128(75-137(190)244)171(278)231-131(83-238)173(280)214-115(54-61-288-19)157(264)210-112(46-51-139(246)247)153(260)208-109(43-34-60-199-181(193)194)159(266)234-144(94(14)15)175(282)215-113(47-52-140(248)249)156(263)222-122(69-98-77-200-104-38-26-25-37-102(98)104)165(272)220-120(66-91(8)9)161(268)209-108(42-33-59-198-180(191)192)151(258)206-106(40-28-31-57-183)150(257)207-107(41-29-32-58-184)152(259)218-118(64-89(4)5)162(269)211-110(44-49-133(186)240)154(261)228-129(76-142(252)253)172(279)235-145(95(16)17)176(283)229-125(72-101-80-197-87-204-101)168(275)227-127(74-136(189)243)170(277)230-130(179(286)287)68-97-35-23-22-24-36-97/h22-26,35-38,77-80,85-96,103,105-132,143-146,200,237-239H,21,27-34,39-76,81-84,182-185H2,1-20H3,(H2,186,240)(H2,187,241)(H2,188,242)(H2,189,243)(H2,190,244)(H,195,202)(H,196,203)(H,197,204)(H,201,255)(H,205,245)(H,206,258)(H,207,257)(H,208,260)(H,209,268)(H,210,264)(H,211,269)(H,212,281)(H,213,270)(H,214,280)(H,215,282)(H,216,285)(H,217,276)(H,218,259)(H,219,262)(H,220,272)(H,221,273)(H,222,263)(H,223,256)(H,224,265)(H,225,271)(H,226,274)(H,227,275)(H,228,261)(H,229,283)(H,230,277)(H,231,278)(H,232,284)(H,233,254)(H,234,266)(H,235,279)(H,236,267)(H,246,247)(H,248,249)(H,250,251)(H,252,253)(H,286,287)(H4,191,192,198)(H4,193,194,199)/t96-,103-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,127-,128-,129-,130-,131-,132-,143-,144-,145-,146-/m0/s1
2.1.3 InChI Key
OGBMKVWORPGQRR-UMXFMPSGSA-N
2.1.4 Canonical SMILES
CCC(C)C(C(=O)NC(CCC(=O)N)C(=O)NC(CC(C)C)C(=O)NC(CCSC)C(=O)NC(CC1=CNC=N1)C(=O)NC(CC(=O)N)C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CC2=CNC=N2)C(=O)NC(CC(C)C)C(=O)NC(CC(=O)N)C(=O)NC(CO)C(=O)NC(CCSC)C(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CC3=CNC4=CC=CC=C43)C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)N)C(=O)NC(CC(=O)O)C(=O)NC(C(C)C)C(=O)NC(CC5=CNC=N5)C(=O)NC(CC(=O)N)C(=O)NC(CC6=CC=CC=C6)C(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)C)NC(=O)C(CO)N
2.1.5 Isomeric SMILES
CC[C@H](C)[C@@H](C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC1=CNC=N1)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC2=CNC=N2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC3=CNC4=CC=CC=C43)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC5=CNC=N5)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](CC6=CC=CC=C6)C(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CO)N
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Hpth (1-34)

2. Human Parathyroid Hormone (1-34)

3. Parathar

4. Teriparatide

5. Teriparatide Acetate

2.2.2 Depositor-Supplied Synonyms

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

2.3 Create Date
2007-07-04
3 Chemical and Physical Properties
Molecular Weight 4118 g/mol
Molecular Formula C181H291N55O51S2
XLogP3-18.7
Hydrogen Bond Donor Count60
Hydrogen Bond Acceptor Count62
Rotatable Bond Count146
Exact Mass4116.1342973 g/mol
Monoisotopic Mass4115.1309424 g/mol
Topological Polar Surface Area1800 Ų
Heavy Atom Count289
Formal Charge0
Complexity9740
Isotope Atom Count0
Defined Atom Stereocenter Count34
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

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


4.2 Drug Warning

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.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 Absorption, Distribution and Excretion

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


5.3 Biological Half-Life

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


5.4 Mechanism of Action

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


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VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697999400,"product":"PARATHYROID HORMONE (1-34),HUMAN, ACETATE (TERIPARATIDE) (29G)","address":"H NO.141, SILPA BRINDAVAN,","city":"KUKATPALLY, HYDERABAD, AP.","supplier":"POLYPEPTIDE GROUP","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"ORBICULAR PHARMACEUTICAL TECHNOLOGIES ","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.029","unit":"KGS","unitRateFc":"3600000","totalValueFC":"106528.1","currency":"USD","unitRateINR":"305733103.5","date":"23-Oct-2023","totalValueINR":"8866260","totalValueInUsd":"106528.1","indian_port":"Hyderabad Air","hs_no":"29379090","bill_no":"8429825","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"365 Maple Avenue Torrance, CA 90503USA United StatesSDNF United States","customerAddress":"H NO.141, SILPA BRINDAVAN,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"PARATHYROID HORMONE (1-34), HUMAN, ACETATE (TERIPARATIDE) (0.5G)","address":"H NO.141, SILPA BRINDAVAN,","city":"KUKATPALLY, HYDERABAD, AP.","supplier":"POLYPEPTIDE GROUP","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"ORBICULAR PHARMACEUTICAL TECHNOLOGIES ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0005","unit":"KGS","unitRateFc":"3600000","totalValueFC":"2731","currency":"USD","unitRateINR":"456570000","date":"22-Jul-2024","totalValueINR":"228285","totalValueInUsd":"2731","indian_port":"Hyderabad Air","hs_no":"29379090","bill_no":"4646724","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"365 Maple Avenue - Torrance - CA -90503 - United StatesSDNF United States","customerAddress":"H NO.141, SILPA BRINDAVAN,"}]
29-May-2021
31-Jul-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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Europe

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01

Accord Healthcare AG

United Kingdom
BIO Partnering at JPM
Not Confirmed
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Accord Healthcare AG

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Teriparatidum ADNr

Brand Name : Sondelbay

Dosage Form : Inj L?s

Dosage Strength : 20mcg/80mcl,ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Teriparatide

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

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03

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Teriparatid

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

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04

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Teriparatid

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

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05

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Teriparatid

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

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06

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Teriparatidum ADNr

Brand Name : Terrosa

Dosage Form : Inj Solution

Dosage Strength : 250mcg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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07

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Teriparatide

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

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08

Mepha Pharma AG

Switzerland
BIO Partnering at JPM
Not Confirmed
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Mepha Pharma AG

Switzerland
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BIO Partnering at JPM
Not Confirmed

Teriparatide

Brand Name : Teriparatide-Mepha

Dosage Form : Inj Solution

Dosage Strength : 250mcg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

Orifarm AS

Denmark
BIO Partnering at JPM
Not Confirmed
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Orifarm AS

Denmark
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BIO Partnering at JPM
Not Confirmed

Teriparatid

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

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10

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Teriparatid

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

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ABOUT THIS PAGE

Teriparatide Manufacturers

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.

Teriparatide Suppliers

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.

Teriparatide USDMF

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.

Teriparatide NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Teriparatide API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Teriparatide CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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