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1. 13496, Sm
2. Hcl, Lurasidone
3. Hydrochloride, Lurasidone
4. Latuda
5. Lurasidone
6. Lurasidone Hcl
7. N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide
8. Sm 13,496
9. Sm 13496
10. Sm-13,496
11. Sm-13496
12. Sm13,496
13. Sm13496
1. Lurasidone Hcl
2. 367514-88-3
3. Latuda
4. Sm-13496
5. Lurasidone Hydrochloride [usan]
6. Sm 13496
7. Chebi:70732
8. O0p4i5851i
9. Lurasidonhydrochloride
10. (1s,2r,6s,7r)-4-[[(1r,2r)-2-[[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione;hydrochloride
11. (3ar,4s,7r,7as)-2-(((1r,2r)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione Hydrochloride
12. (1r,2s,6r,7s)-4-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0^{2,6}]decane-3,5-dione Hydrochloride
13. 4,7-methano-1h-isoindole-1,3(2h)-dione, 2-(((1r,2r)-2-((4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)methyl)cyclohexyl)methyl)hexahydro-, Monohydrochloride, (3ar,4s,7r,7as)-
14. Unii-o0p4i5851i
15. Latuda (tn)
16. Lurasidone Monohydrochloride
17. Lurasidone-d8 Hydrochloride
18. Sm-13496 (hydrochloride)
19. Schembl1534132
20. Chembl1615372
21. Dtxsid401027714
22. Lurasidone Hydrochloride (jan/usan)
23. Lurasidone Hydrochloride [mi]
24. S3044
25. Smp-13496
26. Lurasidone Hydrochloride [jan]
27. Akos022185856
28. Ex-3125
29. Mk-3756
30. Lurasidone Hydrochloride [mart.]
31. Lurasidone Hydrochloride [vandf]
32. Lurasidone Hydrochloride [who-dd]
33. As-35074
34. Lurasidone Hydrochloride, >=98% (hplc)
35. Lurasidone Hydrochloride [orange Book]
36. D04820
37. Q27882070
38. (3ar,4s,7r,7as)-2-((1r,2r)-2-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2h-isoindole-1,3-dione, Hydrochloride
39. (3ar,4s,7r,7as)-2-{(1r,2r)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2h-isoindole-1,3-dione Hydrochloride
40. (3ar,4s,7r,7as)-2-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione Hydrochloride
41. 4-(1,2-benzothiazol-3-yl)-1-{[(1r,2r)-2-{[(3ar,4s,7r,7as)-1,3-dioxooctahydro-2h-4,7-methanoisoindol-2-yl]methyl}cyclohexyl]methyl}piperazin-1-ium Chloride
42. Lurasidone Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
| Molecular Weight | 529.1 g/mol |
|---|---|
| Molecular Formula | C28H37ClN4O2S |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 5 |
| Exact Mass | 528.2325753 g/mol |
| Monoisotopic Mass | 528.2325753 g/mol |
| Topological Polar Surface Area | 85 Ų |
| Heavy Atom Count | 36 |
| Formal Charge | 0 |
| Complexity | 804 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| 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 | Latuda |
| PubMed Health | Lurasidone (By mouth) |
| Drug Classes | Antipsychotic, Central Nervous System Agent |
| Drug Label | LATUDA is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3... |
| Active Ingredient | Lurasidone hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 120mg; 60mg; 80mg; 40mg; 20mg |
| Market Status | Prescription |
| Company | Sunovion Pharms |
| 2 of 2 | |
|---|---|
| Drug Name | Latuda |
| PubMed Health | Lurasidone (By mouth) |
| Drug Classes | Antipsychotic, Central Nervous System Agent |
| Drug Label | LATUDA is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3... |
| Active Ingredient | Lurasidone hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 120mg; 60mg; 80mg; 40mg; 20mg |
| Market Status | Prescription |
| Company | Sunovion Pharms |
Treatment of schizophrenia in adults aged 18 years and over.
Treatment of schizophrenia
Adrenergic alpha-2 Receptor Antagonists
Drugs that bind to and block the activation of ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Antagonists.)
Antipsychotic Agents
Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)
Dopamine D2 Receptor Antagonists
Compounds and drugs that bind to and inhibit or block the activation of DOPAMINE D2 RECEPTORS. (See all compounds classified as Dopamine D2 Receptor Antagonists.)
Serotonin 5-HT2 Receptor Antagonists
Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes. (See all compounds classified as Serotonin 5-HT2 Receptor Antagonists.)
N05AE05

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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Lurasidone HCl is a D2 and 5HT2A inhibitor, indicated for the management of schizophrenia and bipolar depression.
Lead Product(s): Lurasidone Hydrochloride,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Latuda-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 06, 2025

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Lead Product(s) : Lurasidone Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Sunshine Biopharma Launches Generic Lurasidone for Schizophrenia in Canada
Details : Lurasidone HCl is a D2 and 5HT2A inhibitor, indicated for the management of schizophrenia and bipolar depression.
Product Name : Latuda-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 06, 2025

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NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 06, 2024

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
NRx Reports Trial Results Showing Safety of NRX-101 in Suicidal Bipolar Depression
Details : NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 06, 2024

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NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 30, 2024

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
NRx Announces Promising Findings in Phase 2b/3 of NRX-101 for Suicidal Bipolar Depression
Details : NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 30, 2024

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NRX-101 (D-cycloserine & Lurasidone HCl) shows no measurable damage to intestinal or vaginal flora in rodent models of urinary tract infections and associated complications.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 17, 2024

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
NRx Reports NRX-101 Shows No Damage To Intestinal Flora
Details : NRX-101 (D-cycloserine & Lurasidone HCl) shows no measurable damage to intestinal or vaginal flora in rodent models of urinary tract infections and associated complications.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 17, 2024

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NRX-101, a combination of the NMDA antagonist D-cycloserine and lurasidone, is in phase 2/3 trials for treating resistant bipolar depression and suicidal ideation.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 04, 2024

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
NRx Pharmaceuticals Announces Last Patient, Last Visit in Phase 2b/3 Trial Of NRX-101
Details : NRX-101, a combination of the NMDA antagonist D-cycloserine and lurasidone, is in phase 2/3 trials for treating resistant bipolar depression and suicidal ideation.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 04, 2024

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The collaborations aim to support NRx for the development of NRX-101 (D-cycloserine) in the treatment of bipolar depression with suicidality.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Alvogen
Deal Size: $345.0 million Upfront Cash: $10.0 million
Deal Type: Collaboration February 11, 2024

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Alvogen
Deal Size : $345.0 million
Deal Type : Collaboration
NRx Pharmaceuticals Announces $5 Million Milestone from Alvogen and Lotus Pharma
Details : The collaborations aim to support NRx for the development of NRX-101 (D-cycloserine) in the treatment of bipolar depression with suicidality.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : $10.0 million
February 11, 2024

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NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, is in phase 2/3 trials for treatment-resistant bipolar depression and suicidal ideation.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 22, 2024

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
NRx Pharmaceuticals Completes Enrollment Of Phase 2b/3 Trial Of NRX-101
Details : NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, is in phase 2/3 trials for treatment-resistant bipolar depression and suicidal ideation.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 22, 2024

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NRX-101 combines D-cycloserine and lurasidone, currently in Phase 2 for treating complicated urinary tract infections and pyelonephritis.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 16, 2024

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
NRx Pharmaceuticals Announces FDA QIDP and Fast Track Designation for NRX-101
Details : NRX-101 combines D-cycloserine and lurasidone, currently in Phase 2 for treating complicated urinary tract infections and pyelonephritis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 16, 2024

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NRX-101 is an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor. It is being evaluated for the treatment of complicated Urinary Tract Infections.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: IND EnablingProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 18, 2023

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : NRX-101 is an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor. It is being evaluated for the treatment of complicated Urinary Tract Infections.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 18, 2023

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D-Cycloserine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Tract Infections.
Lead Product(s): Cycloserine,Lurasidone Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Amino Acid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 13, 2023

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Lead Product(s) : Cycloserine,Lurasidone Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis
Details : D-Cycloserine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Tract Infections.
Product Name : Undisclosed
Product Type : Amino Acid
Upfront Cash : Inapplicable
November 13, 2023

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PharmaCompass offers a list of Lurasidone Hydrochloride 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 Lurasidone Hydrochloride manufacturer or Lurasidone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lurasidone Hydrochloride manufacturer or Lurasidone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Lurasidone Hydrochloride API Price utilized in the formulation of products. Lurasidone Hydrochloride API Price is not always fixed or binding as the Lurasidone Hydrochloride Price is obtained through a variety of data sources. The Lurasidone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A latuda manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of latuda, including repackagers and relabelers. The FDA regulates latuda manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. latuda 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 latuda manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A latuda supplier is an individual or a company that provides latuda active pharmaceutical ingredient (API) or latuda finished formulations upon request. The latuda suppliers may include latuda API manufacturers, exporters, distributors and traders.
click here to find a list of latuda suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A latuda DMF (Drug Master File) is a document detailing the whole manufacturing process of latuda active pharmaceutical ingredient (API) in detail. Different forms of latuda DMFs exist exist since differing nations have different regulations, such as latuda USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A latuda DMF submitted to regulatory agencies in the US is known as a USDMF. latuda USDMF includes data on latuda's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The latuda USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of latuda suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The latuda Drug Master File in Japan (latuda JDMF) empowers latuda API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the latuda JDMF during the approval evaluation for pharmaceutical products. At the time of latuda JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of latuda suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a latuda Drug Master File in Korea (latuda KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of latuda. The MFDS reviews the latuda KDMF as part of the drug registration process and uses the information provided in the latuda KDMF to evaluate the safety and efficacy of the drug.
After submitting a latuda KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their latuda API can apply through the Korea Drug Master File (KDMF).
click here to find a list of latuda suppliers with KDMF on PharmaCompass.
A latuda written confirmation (latuda WC) is an official document issued by a regulatory agency to a latuda manufacturer, verifying that the manufacturing facility of a latuda active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting latuda APIs or latuda finished pharmaceutical products to another nation, regulatory agencies frequently require a latuda WC (written confirmation) as part of the regulatory process.
click here to find a list of latuda suppliers with Written Confirmation (WC) 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 latuda as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for latuda 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 latuda 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 latuda and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a latuda NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of latuda suppliers with NDC on PharmaCompass.
latuda 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 latuda 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 latuda GMP manufacturer or latuda GMP API supplier for your needs.
A latuda CoA (Certificate of Analysis) is a formal document that attests to latuda's compliance with latuda specifications and serves as a tool for batch-level quality control.
latuda CoA mostly includes findings from lab analyses of a specific batch. For each latuda 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.
latuda may be tested according to a variety of international standards, such as European Pharmacopoeia (latuda EP), latuda JP (Japanese Pharmacopeia) and the US Pharmacopoeia (latuda USP).