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1. 188re-lanreotide
2. 2-naphthylalanyl-cyclo(cysteinyl-tyrosyl-tryptophyl-lysyl-valyl-cysteinyl)-threoninamide
3. 3-(2-naphthyl)-d-ala-cys-tyr-d-trp-lys-val-cys-thr-nh2
4. 3-(2-naphthyl)alanyl-cystinyl-tyrosyl-tryptophyl-lysyl-valyl-cystinyl-threonine Amide
5. Angiopeptin
6. Bim 23014
7. Bim 23014 C
8. Bim 23014c
9. Bim-23014
10. Bim-23014 C
11. D-nal-cys-tyr-trp-lys-val-cys-thr-nh2
12. Dc 13-116
13. Dc-13-116
14. Dc13-116
15. L-threoninamide, 3-(2-naphthalenyl)-d-alanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-valyl-l-cysteinyl-, Cyclic (2-7)-disulfide
16. Lanreotide
17. Lanreotide Acetate
18. Lanreotide-sr
19. Nal-cyclo(cys-tyr-trp-lys-val-cys)-thr-nh2
20. Nal-cyclo(cys-tyr-trp-lys-val-cys)thr-nh2
21. Naphthalenyl-cyclo(cysteinyl-tyrosyl-tryptophyl-lysyl-valyl-cysteinyl)threoninamide
22. Naphthyl-cyclo(cys-tyr-trp-lys-val-cys)thr-nh2
23. Somatulin
24. Somatulina
25. Somatuline
1. Somatuline Lp
2. Lanreotide (acetate)
3. Bim-23014c
4. Ipstyl
5. Somatuline
6. Somatuline Autogel
7. 2378114-72-6
8. Angiopeptin Acetate
9. Somatulina
10. Somatuline La
11. Acetic Acid;(4r,7s,10s,13r,16s,19r)-10-(4-aminobutyl)-n-[(2s,3r)-1-amino-3-hydroxy-1-oxobutan-2-yl]-19-[[(2r)-2-amino-3-naphthalen-2-ylpropanoyl]amino]-16-[(4-hydroxyphenyl)methyl]-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-7-propan-2-yl-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide
12. Chembl1201184
13. Hy-p1959a
14. Itm-014
15. Mfcd00873576
16. Bn-52030
17. Dc13-116
18. Cs-0113779
19. P1088
Molecular Weight | 1156.4 g/mol |
---|---|
Molecular Formula | C56H73N11O12S2 |
Hydrogen Bond Donor Count | 14 |
Hydrogen Bond Acceptor Count | 16 |
Rotatable Bond Count | 17 |
Exact Mass | 1155.48815915 g/mol |
Monoisotopic Mass | 1155.48815915 g/mol |
Topological Polar Surface Area | 443 Ų |
Heavy Atom Count | 81 |
Formal Charge | 0 |
Complexity | 2030 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Somatuline depot |
PubMed Health | Lanreotide (Subcutaneous) |
Drug Classes | Endocrine-Metabolic Agent |
Drug Label | Somatuline Depot (lanreotide) Injection 60, 90 and 120 mg is a prolonged-release formulation for deep subcutaneous injection containing the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occ... |
Active Ingredient | Lanreotide acetate |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | eq 90mg base; eq 120mg base; eq 60mg base |
Market Status | Prescription |
Company | Ipsen Pharma |
2 of 2 | |
---|---|
Drug Name | Somatuline depot |
PubMed Health | Lanreotide (Subcutaneous) |
Drug Classes | Endocrine-Metabolic Agent |
Drug Label | Somatuline Depot (lanreotide) Injection 60, 90 and 120 mg is a prolonged-release formulation for deep subcutaneous injection containing the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occ... |
Active Ingredient | Lanreotide acetate |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | eq 90mg base; eq 120mg base; eq 60mg base |
Market Status | Prescription |
Company | Ipsen Pharma |
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Details:
Lanreotide generic injection is approved by FDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.
Lead Product(s): Lanreotide Acetate
Therapeutic Area: Endocrinology Brand Name: Somatuline Depot-Generic
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 22, 2024
Lead Product(s) : Lanreotide Acetate
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Cipla Gets Approval for Generic Somatuline® Depot Injection (Lanreotide)
Details : Lanreotide generic injection is approved by FDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.
Product Name : Somatuline Depot-Generic
Product Type : Peptide
Upfront Cash : Inapplicable
May 22, 2024
Details:
Debio 4126 (octreotide) is a synthetic octapeptide that mimics the pharmacology of endogenous somatostatin (SST). It demonstrates activity against growth hormone and glucagon, treating the disordered tissue growth and insulin regulation in patients with acromegaly.
Lead Product(s): Octreotide Acetate,Lanreotide Acetate
Therapeutic Area: Endocrinology Brand Name: Debio 4126
Study Phase: Phase IProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 01, 2023
Lead Product(s) : Octreotide Acetate,Lanreotide Acetate
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Debio 4126 (octreotide) is a synthetic octapeptide that mimics the pharmacology of endogenous somatostatin (SST). It demonstrates activity against growth hormone and glucagon, treating the disordered tissue growth and insulin regulation in patients with ...
Product Name : Debio 4126
Product Type : Peptide
Upfront Cash : Inapplicable
December 01, 2023
Details:
New data presented at ENETS 2022 showed patients treated with Somatuline Autogel and Somatuline Depot (lanreotide) pre-filled syringe reported less frequent injection-site pain lasting more than two days than those treated with octreotide long-acting release syringe.
Lead Product(s): Lanreotide Acetate
Therapeutic Area: Oncology Brand Name: Somatuline Autogel
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 03, 2022
Lead Product(s) : Lanreotide Acetate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : New data presented at ENETS 2022 showed patients treated with Somatuline Autogel and Somatuline Depot (lanreotide) pre-filled syringe reported less frequent injection-site pain lasting more than two days than those treated with octreotide long-acting rel...
Product Name : Somatuline Autogel
Product Type : Peptide
Upfront Cash : Inapplicable
August 03, 2022
Details:
Ipsen’s extensive experience with Somatuline Autogel / Somatuline Depot has offered deep insights into the challenges of living with gastroenteropancreatic neuroendocrine tumors, carcinoid syndrome or acromegaly.
Lead Product(s): Lanreotide Acetate
Therapeutic Area: Oncology Brand Name: Somatuline Autogel
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Phillips - Medisize
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing March 16, 2022
Lead Product(s) : Lanreotide Acetate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Phillips - Medisize
Deal Size : Undisclosed
Deal Type : Financing
Details : Ipsen’s extensive experience with Somatuline Autogel / Somatuline Depot has offered deep insights into the challenges of living with gastroenteropancreatic neuroendocrine tumors, carcinoid syndrome or acromegaly.
Product Name : Somatuline Autogel
Product Type : Peptide
Upfront Cash : Undisclosed
March 16, 2022
Details:
Company received final approval for its Lanreotide acetate-Generic Injection, from USFDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.
Lead Product(s): Lanreotide Acetate
Therapeutic Area: Endocrinology Brand Name: Somatuline Depot-Generic
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 19, 2021
Lead Product(s) : Lanreotide Acetate
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Cipla Receives Final Approval for Lanreotide Injection
Details : Company received final approval for its Lanreotide acetate-Generic Injection, from USFDA for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors.
Product Name : Somatuline Depot-Generic
Product Type : Peptide
Upfront Cash : Inapplicable
December 19, 2021
Details:
Increasing the dose frequency of lanreotidefrom monthly to bi-monthly achieved a progression-free survival of 8.3 months in patients with progressive midgut neuroendocrine tumors (NETs) and 5.6 months in patients with progressive pancreatic NETs.
Lead Product(s): Lanreotide Acetate
Therapeutic Area: Oncology Brand Name: Somatuline Autogel
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 18, 2020
Lead Product(s) : Lanreotide Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Increasing the dose frequency of lanreotidefrom monthly to bi-monthly achieved a progression-free survival of 8.3 months in patients with progressive midgut neuroendocrine tumors (NETs) and 5.6 months in patients with progressive pancreatic NETs.
Product Name : Somatuline Autogel
Product Type : Peptide
Upfront Cash : Inapplicable
September 18, 2020
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : SOMATULINE AUTOGEL 60
Dosage Form : PFS
Dosage Strength : 60mg/0.5ml
Packaging : 0.5X1mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : SOMATULINE AUTOGEL 90
Dosage Form : PFS
Dosage Strength : 90mg/0.5ml
Packaging : 0.5X1mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : SOMATULINE AUTOGEL 120
Dosage Form : PFS
Dosage Strength : 120mg/0.5ml
Packaging : 0.5X1mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 60MG/0.2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 90MG/0.3ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 120MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 60MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 90MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 120MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Regulatory Info :
Registration Country : Australia
Brand Name : Somatuline Autogel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Italy
Brand Name : Ipstyl
Dosage Form : Lanreotide 90Mg 1 Unit Parenteral Use
Dosage Strength : 1 syringe SC 90 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : IPSTYL
Dosage Form : Solution For Injection For Subcutaneous
Dosage Strength : 90 mg
Packaging : 1 UNIT 90 MG - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Somatulina AUTOGEL
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 90 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Somatuline AUTOGEL
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 60 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Ipstyl
Dosage Form : Injection fluid, resolution in the finished filled syringe
Dosage Strength : 120 mg
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Myrelez
Dosage Form : Solution for injection, solution in pre-filled syringe
Dosage Strength : 90 mg
Packaging : Pre-filled syringe 1 0.5ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : Ipstyl AUTOGEL
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 90 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Somatulina AUTOGEL
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 60 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Somatuline AUTOGEL
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 120 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Somatuline AUTOGEL
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 90 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
LANREOTIDE (LANREOTIDE ACETATE)
Brand Name : SOMATULINE AUTOGEL
Dosage Form : SOLUTION (EXTENDED RELEASE)
Dosage Strength : 60MG/SYR
Packaging : 60MG/SYRINGE
Approval Date :
Application Number : 2283395
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
LANREOTIDE (LANREOTIDE ACETATE)
Brand Name : SOMATULINE AUTOGEL
Dosage Form : SOLUTION (EXTENDED RELEASE)
Dosage Strength : 90MG/SYR
Packaging : 90MG/SYRINGE
Approval Date :
Application Number : 2283409
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
LANREOTIDE (LANREOTIDE ACETATE)
Brand Name : SOMATULINE AUTOGEL
Dosage Form : SOLUTION (EXTENDED RELEASE)
Dosage Strength : 120MG/SYR
Packaging : 120MG/SYRINGE
Approval Date :
Application Number : 2283417
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Mytolac
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Mytolac
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Mytolac
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Mytolac
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Mytolac
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Somatuline Autogel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Somatuline Autogel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Somatuline Autogel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Somatuline Autogel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Somatuline Autogel
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : SOMATULINE AUTOGEL 60
Dosage Form : PFS
Dosage Strength : 60mg/0.5ml
Packaging : 0.5X1mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : SOMATULINE AUTOGEL 90
Dosage Form : PFS
Dosage Strength : 90mg/0.5ml
Packaging : 0.5X1mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : SOMATULINE AUTOGEL 120
Dosage Form : PFS
Dosage Strength : 120mg/0.5ml
Packaging : 0.5X1mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 60MG/0.2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Under De...
Dosage : Injection
Dosage Strength : 60MG/0.2ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 90MG/0.3ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Under De...
Dosage : Injection
Dosage Strength : 90MG/0.3ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 120MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Under De...
Dosage : Injection
Dosage Strength : 120MG/0.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 60MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Long Acting Injectable
Dosage Strength : 60MG/SYRINGE
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 90MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Long Acting Injectable
Dosage Strength : 90MG/SYRINGE
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Long Acting Injectable
Dosage Strength : 120MG/SYRINGE
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Long Acting Injectable
Dosage Strength : 120MG/SYRINGE
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Pre Filled Syringe
Dosage Strength : 60MG/0.2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Pre Filled Syringe
Dosage Strength : 60MG/0.2ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Pre Filled Syringe
Dosage Strength : 90MG/0.3ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Pre Filled Syringe
Dosage Strength : 90MG/0.3ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Pre Filled Syringe
Dosage Strength : 120MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Pre Filled Syringe
Dosage Strength : 120MG/0.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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38
PharmaCompass offers a list of Lanreotide Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lanreotide Acetate manufacturer or Lanreotide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lanreotide Acetate manufacturer or Lanreotide Acetate supplier.
PharmaCompass also assists you with knowing the Lanreotide Acetate API Price utilized in the formulation of products. Lanreotide Acetate API Price is not always fixed or binding as the Lanreotide Acetate Price is obtained through a variety of data sources. The Lanreotide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lanreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanreotide, including repackagers and relabelers. The FDA regulates Lanreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanreotide 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 Lanreotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lanreotide supplier is an individual or a company that provides Lanreotide active pharmaceutical ingredient (API) or Lanreotide finished formulations upon request. The Lanreotide suppliers may include Lanreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Lanreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lanreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanreotide active pharmaceutical ingredient (API) in detail. Different forms of Lanreotide DMFs exist exist since differing nations have different regulations, such as Lanreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Lanreotide USDMF includes data on Lanreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lanreotide 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 Lanreotide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lanreotide 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 Lanreotide 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 Lanreotide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lanreotide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lanreotide suppliers with NDC on PharmaCompass.
Lanreotide 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 Lanreotide 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 Lanreotide GMP manufacturer or Lanreotide GMP API supplier for your needs.
A Lanreotide CoA (Certificate of Analysis) is a formal document that attests to Lanreotide's compliance with Lanreotide specifications and serves as a tool for batch-level quality control.
Lanreotide CoA mostly includes findings from lab analyses of a specific batch. For each Lanreotide 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.
Lanreotide may be tested according to a variety of international standards, such as European Pharmacopoeia (Lanreotide EP), Lanreotide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lanreotide USP).