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Chemistry

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Also known as: Berotralstat, 1809010-50-1, Bcx7353, Berotralstat [inn], Berotralstat [usan], Xza0kb1bdq
Molecular Formula
C30H26F4N6O
Molecular Weight
562.6  g/mol
InChI Key
UXNXMBYCBRBRFD-MUUNZHRXSA-N
FDA UNII
XZA0KB1BDQ

Berotralstat Hydrochloride
Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Developed by BioCryst Pharmaceuticals, berotralstat is taken once-daily as oral capsules. Under the market name Orladeyo, berotralstat was approved by the FDA on December 3, 2020, as the first oral, once-daily therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. In clinical trials, berotralstat was shown to significantly reduce attack rates at 24 weeks compared to placebo, which was sustained through 48 weeks. Berotralstat is strictly used to prevent, but not treat, these attacks. Previous oral therapies used for prophylaxis of HAE attacks, such as androgens, were limited by undesirable adverse effects and several contraindications. In clinical trials, berotralstat displayed a fast onset of action, long duration of action, and acceptable tolerance in patients.
Berotralstat is a Plasma Kallikrein Inhibitor. The mechanism of action of berotralstat is as a Kallikrein Inhibitor, and Cytochrome P450 2D6 Inhibitor, and Cytochrome P450 3A4 Inhibitor, and P-Glycoprotein Inhibitor.
1 2D Structure

Berotralstat Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[3-(aminomethyl)phenyl]-N-[5-[(R)-(3-cyanophenyl)-(cyclopropylmethylamino)methyl]-2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide
2.1.2 InChI
InChI=1S/C30H26F4N6O/c31-24-10-9-22(28(37-17-18-7-8-18)21-5-1-3-19(11-21)15-35)13-25(24)38-29(41)26-14-27(30(32,33)34)39-40(26)23-6-2-4-20(12-23)16-36/h1-6,9-14,18,28,37H,7-8,16-17,36H2,(H,38,41)/t28-/m1/s1
2.1.3 InChI Key
UXNXMBYCBRBRFD-MUUNZHRXSA-N
2.1.4 Canonical SMILES
C1CC1CNC(C2=CC(=C(C=C2)F)NC(=O)C3=CC(=NN3C4=CC=CC(=C4)CN)C(F)(F)F)C5=CC=CC(=C5)C#N
2.1.5 Isomeric SMILES
C1CC1CN[C@@H](C2=CC(=C(C=C2)F)NC(=O)C3=CC(=NN3C4=CC=CC(=C4)CN)C(F)(F)F)C5=CC=CC(=C5)C#N
2.2 Other Identifiers
2.2.1 UNII
XZA0KB1BDQ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

2. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)

3. Bcx-7353

4. Bcx7353

5. Berotralstat

2.3.2 Depositor-Supplied Synonyms

1. Berotralstat

2. 1809010-50-1

3. Bcx7353

4. Berotralstat [inn]

5. Berotralstat [usan]

6. Xza0kb1bdq

7. Bcx-7353

8. Berotralstat (usan)

9. 2-[3-(aminomethyl)phenyl]-n-[5-[(r)-(3-cyanophenyl)-(cyclopropylmethylamino)methyl]-2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide

10. 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

11. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-

12. 1-[3-(aminomethyl)phenyl]-n-(5-{(r)-(3-cyanophenyl)[(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

13. Unii-xza0kb1bdq

14. Berotralstat [usan:inn]

15. Berotralstat [who-dd]

16. Schembl21974728

17. Gtpl11347

18. Dtxsid401336676

19. Ex-a5537

20. Who 10907

21. Hy-109127

22. Cs-0086757

23. D11673

24. (r)-1-(3-(aminomethyl)phenyl)-n-(5-((3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

25. 0ri

26. 1-[3-(aminomethyl)phenyl]-n-(5-{(r)-[3-(aminomethyl)phenyl][(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

27. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)

2.4 Create Date
2019-03-16
3 Chemical and Physical Properties
Molecular Weight 562.6 g/mol
Molecular Formula C30H26F4N6O
XLogP34.5
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count9
Rotatable Bond Count9
Exact Mass562.21042212 g/mol
Monoisotopic Mass562.21042212 g/mol
Topological Polar Surface Area109 Ų
Heavy Atom Count41
Formal Charge0
Complexity938
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Berotralstat is indicated for prophylaxis of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. It is not used for the treatment of acute HAE attacks.


Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Berotralstat prevents angioedema attacks by inhibiting plasma kallikrein, thereby regulating excess bradykinin generation in patients with hereditary angioedema. It has a fast onset of action, long duration of action, and acceptable tolerance. Berotralstat inhibits plasma kallikrein in a concentration-dependent. In clinical trials, doses of berotralstat higher than 150 mg once daily led to QT Prolongation in a concentration-dependent manner.


5.2 MeSH Pharmacological Classification

Serine Proteinase Inhibitors

Exogenous or endogenous compounds which inhibit SERINE ENDOPEPTIDASES. (See all compounds classified as Serine Proteinase Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
BEROTRALSTAT
5.3.2 FDA UNII
XZA0KB1BDQ
5.3.3 Pharmacological Classes
Mechanisms of Action [MoA] - P-Glycoprotein Inhibitors
5.4 ATC Code

B06AC


B - Blood and blood forming organs

B06 - Other hematological agents

B06A - Other hematological agents

B06AC - Drugs used in hereditary angioedema

B06AC06 - Berotralstat


5.5 Absorption, Distribution and Excretion

Absorption

The steady-state of berotralstat is reached within 6 to 12 days following initial administration. After once-daily administration, the Cmax and AUC of berotralstat at steady-state is approximately five times that of the drug after a single dose. Following oral administration of berotralstat once-daily, the steady-state Cmax was 158 ng/mL (range: 110 to 234 ng/mL) at the dose of 150 mg and 97.8 ng/mL (range: 63 to 235 ng/mL) at the dose of 110 mg. The area under the curve over the dosing interval (AUCtau) was 2770 ng*hr/mL (range: 1880 to 3790 ng*hr/mL) and 1600 ng*hr/mL (range: 950 to 4170 ng*hr/mL) at the dose of 110 mg. The median Tmax is 2 hours in a fasted state and a high-fat meal delays the Tmax to 5 hours. The Tmax can range from 1 to 8 hours.


Route of Elimination

Following a single oral dose administration of 300 mg radiolabeled berotralstat, approximately 9% of the drug was excreted in the urine, where 1.8 to 4.7% of the total radiolabeled compound accounted for the unchanged parent drug. About 79% of the drug was excreted in feces.


Volume of Distribution

The blood to plasma ratio was approximately 0.92 following a single 300 mg dose administration of radiolabeled berotralstat.


Clearance

There is no information on the clearance rate.


5.6 Metabolism/Metabolites

Berotralstat is metabolized by CYP2D6 and CYP3A4. The metabolic pathway and the metabolites of berotralstat have not yet been characterized. Following a single oral dose administration of 300 mg radiolabeled berotralstat, about 34% of the total plasma radioactivity accounted for the unchanged drug while about eight detectable metabolites accounted for 1.8 to 7.8% of the total radioactivity.


5.7 Biological Half-Life

Following a single oral dose administration of 300 mg radiolabeled berotralstat, the median elimination half-life of berotralstat was approximately 93 hours, ranging from 39 to 152 hours.


5.8 Mechanism of Action

Hereditary angioedema (HAE) is a rare genetic disorder associated with severe swelling of the skin and upper airway. It is caused by mutations in the regulatory or coding regions of the gene that encodes C1 inhibitor (SERPING1), which result in either a deficiency (type I) or dysfunction (type II) of C1 inhibitor (C1 esterase inhibitor, C1-INH). C1 inhibitor is a serine protease inhibitor that normally regulates bradykinin production by covalently binding to and inactivating plasma kallikrein. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK). During HAE attacks, the levels of plasma kallikrein fall, leading to the cleavage of high-molecular-weight-kininogen and the release of bradykinin, a potent vasodilator that increases vascular permeability. Bradykinin plays a major role in promoting edema and pain associated with HAE. Patients with HAE cannot properly regulate plasma kallikrein activity due to the deficiency or dysfunction of a serum inhibitor of C1 inhibitor, leading to uncontrolled increases in plasma kallikrein activity and recurrent angioedema attacks. Berotralstat is a potent inhibitor of plasma kallikrein that works by binding to plasma kallikrein and blocking its proteolytic activity, thereby controlling excess bradykinin generation.


Drugs in Development

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Details:

Orladeyo (berotralstat), plasma kallikrein inhbitor, which is being evaluated for the treatment in pediatric patients with hereditary angioedema aged 2 to <12 years.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 24, 2025

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01

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, which is being evaluated for the treatment in pediatric patients with hereditary angioedema aged 2 to <12 years.

Product Name : Orladeyo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 24, 2025

blank

Details:

Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 12, 2025

blank

02

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.

Product Name : Orladeyo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 12, 2025

blank

Details:

Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 18, 2024

blank

03

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Not Applicable

November 18, 2024

blank

Details:

Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 09, 2024

blank

04

Pint Pharma

Austria
arrow
World ADC London
Not Confirmed

Pint Pharma

Austria
arrow
World ADC London
Not Confirmed

Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Not Applicable

July 09, 2024

blank

Details:

Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: BioCryst Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 13, 2024

blank

05

Pint Pharma

Austria
arrow
World ADC London
Not Confirmed

Pint Pharma

Austria
arrow
World ADC London
Not Confirmed

Details : Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Not Applicable

May 13, 2024

blank

Details:

Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: BioCryst Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 16, 2024

blank

06

Pint Pharma

Austria
arrow
World ADC London
Not Confirmed

Pint Pharma

Austria
arrow
World ADC London
Not Confirmed

Details : Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Not Applicable

April 16, 2024

blank

Details:

Argentina's regulatory body approved the drug product, Orladeyo® (berotralstat), a plasma kallikrein inhibitor, is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 29, 2023

blank

07

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Argentina's regulatory body approved the drug product, Orladeyo® (berotralstat), a plasma kallikrein inhibitor, is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older.

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Not Applicable

November 29, 2023

blank

Details:

Orladeyo (berotralstat) is an oral, once-daily, plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 21, 2023

blank

08

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Orladeyo (berotralstat) is an oral, once-daily, plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Not Applicable

November 21, 2023

blank

Details:

Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 18, 2023

blank

09

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Not Applicable

September 18, 2023

blank

Details:

Under the collaboration, Er-Kim Pharmaceuticals will commercialize Orladeyo (berotralstat), the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older, in Turkey.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: BioCryst Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration July 19, 2023

blank

10

Erkim

Turkey
arrow
World ADC London
Not Confirmed

Erkim

Turkey
arrow
World ADC London
Not Confirmed

Details : Under the collaboration, Er-Kim Pharmaceuticals will commercialize Orladeyo (berotralstat), the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older, in Tur...

Product Name : Orladeyo

Product Type : Small molecule

Upfront Cash : Undisclosed

July 19, 2023

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FDF Dossiers

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World ADC London
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BEROTRALSTAT HYDROCHLORIDE

Brand Name : ORLADEYO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 110MG BASE

Packaging :

Approval Date : 2020-12-03

Application Number : 214094

Regulatory Info : RX

Registration Country : USA

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World ADC London
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BEROTRALSTAT HYDROCHLORIDE

Brand Name : ORLADEYO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 2020-12-03

Application Number : 214094

Regulatory Info : RX

Registration Country : USA

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Not Confirmed
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Berotralstatum

Brand Name : Orladeyo

Dosage Form : Kaps

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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ABOUT THIS PAGE

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API | Excipient name

Berotralstat

Synonyms

1809010-50-1, Bcx7353, Berotralstat [inn], Berotralstat [usan], Xza0kb1bdq, Bcx-7353

Cas Number

1809010-50-1

Unique Ingredient Identifier (UNII)

XZA0KB1BDQ

About Berotralstat

Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Developed by BioCryst Pharmaceuticals, berotralstat is taken once-daily as oral capsules. Under the market name Orladeyo, berotralstat was approved by the FDA on December 3, 2020, as the first oral, once-daily therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. In clinical trials, berotralstat was shown to significantly reduce attack rates at 24 weeks compared to placebo, which was sustained through 48 weeks. Berotralstat is strictly used to prevent, but not treat, these attacks. Previous oral therapies used for prophylaxis of HAE attacks, such as androgens, were limited by undesirable adverse effects and several contraindications. In clinical trials, berotralstat displayed a fast onset of action, long duration of action, and acceptable tolerance in patients.

Berotralstat Hydrochloride Manufacturers

A Berotralstat Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berotralstat Hydrochloride, including repackagers and relabelers. The FDA regulates Berotralstat Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berotralstat Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Berotralstat Hydrochloride Suppliers

A Berotralstat Hydrochloride supplier is an individual or a company that provides Berotralstat Hydrochloride active pharmaceutical ingredient (API) or Berotralstat Hydrochloride finished formulations upon request. The Berotralstat Hydrochloride suppliers may include Berotralstat Hydrochloride API manufacturers, exporters, distributors and traders.

Berotralstat Hydrochloride 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 Berotralstat Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Berotralstat Hydrochloride 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 Berotralstat Hydrochloride 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 Berotralstat Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Berotralstat Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Berotralstat Hydrochloride suppliers with NDC on PharmaCompass.

Berotralstat Hydrochloride GMP

Berotralstat Hydrochloride 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 Berotralstat Hydrochloride 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 Berotralstat Hydrochloride GMP manufacturer or Berotralstat Hydrochloride GMP API supplier for your needs.

Berotralstat Hydrochloride CoA

A Berotralstat Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Berotralstat Hydrochloride's compliance with Berotralstat Hydrochloride specifications and serves as a tool for batch-level quality control.

Berotralstat Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Berotralstat Hydrochloride 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.

Berotralstat Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Berotralstat Hydrochloride EP), Berotralstat Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Berotralstat Hydrochloride 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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