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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

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JDMF

JDMFs Filed

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EU WC

EU WC

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VMF

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EDQM

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USP

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Europe

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Chemistry

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Also known as: Gepirone hcl, Travivo, Gepirone hydrochloride [usan], 83928-66-9, Tgfk07ad, Bmy 13805-1
Molecular Formula
C19H30ClN5O2
Molecular Weight
395.9  g/mol
InChI Key
DGOCVISYYYQFEP-UHFFFAOYSA-N
FDA UNII
80C9L8EP6V

Gepirone
1 2D Structure

Gepirone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4,4-dimethyl-1-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]piperidine-2,6-dione;hydrochloride
2.1.2 InChI
InChI=1S/C19H29N5O2.ClH/c1-19(2)14-16(25)24(17(26)15-19)9-4-3-8-22-10-12-23(13-11-22)18-20-6-5-7-21-18;/h5-7H,3-4,8-15H2,1-2H3;1H
2.1.3 InChI Key
DGOCVISYYYQFEP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1(CC(=O)N(C(=O)C1)CCCCN2CCN(CC2)C3=NC=CC=N3)C.Cl
2.2 Other Identifiers
2.2.1 UNII
80C9L8EP6V
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4,4-dimethyl-1-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-2,6-piperidinedione

2. Bmy 13805

3. Bmy-13805

4. Gepirone

5. Gepirone Monohydrochloride

6. Mj 13805

7. Mj 13805-1

8. Mj-13805

2.3.2 Depositor-Supplied Synonyms

1. Gepirone Hcl

2. Travivo

3. Gepirone Hydrochloride [usan]

4. 83928-66-9

5. Tgfk07ad

6. Bmy 13805-1

7. 80c9l8ep6v

8. Chembl1204187

9. Variza

10. Ariza

11. Bmy-13805-1

12. Gepirone Er

13. 3,3-dimethyl-1-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)glutarimide Monohydrochloride

14. Gepirone Hydrochloride (usan)

15. 2,6-piperidinedione, 4,4-dimethyl-1-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-, Monohydrochloride

16. Bmy-13805

17. Unii-80c9l8ep6v

18. Bmy 138951

19. Schembl318838

20. Dtxsid30232812

21. Org-33062

22. Gepirone Hydrochloride [mart.]

23. Gepirone Hydrochloride [who-dd]

24. Sb19633

25. Mj-13805

26. D04314

27. Q27269140

28. 2,6-piperidinedione, 4,4-dimethyl-1-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, Hydrochloride (1:1)

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 395.9 g/mol
Molecular Formula C19H30ClN5O2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count6
Exact Mass395.2088029 g/mol
Monoisotopic Mass395.2088029 g/mol
Topological Polar Surface Area69.6 Ų
Heavy Atom Count27
Formal Charge0
Complexity476
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)


Antidepressive Agents

Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)


Serotonin Receptor Agonists

Endogenous compounds and drugs that bind to and activate SEROTONIN RECEPTORS. Many serotonin receptor agonists are used as ANTIDEPRESSANTS; ANXIOLYTICS; and in the treatment of MIGRAINE DISORDERS. (See all compounds classified as Serotonin Receptor Agonists.)


API SUPPLIERS

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01

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Metrochem

02

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
HRV Global Life Sciences

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Erregierre SpA

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AGGSpend
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Erregierre SpA

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AGGSpend
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MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Zydus Lifesciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AGGSpend
Not Confirmed
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Zydus Lifesciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Flag India
Digital Content Digital Content

Gepirone

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Digital Content Digital Content

Gepirone

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

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Gepirone

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Gepirone

About the Company : Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states...

Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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FDA Orange Book

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01

FABRE KRAMER

U.S.A
AGGSpend
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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

Brand Name : EXXUA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 18.2MG BASE

Approval Date : 2023-09-22

Application Number : 21164

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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FABRE KRAMER

U.S.A
AGGSpend
Not Confirmed
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FABRE KRAMER

U.S.A
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Not Confirmed

GEPIRONE HYDROCHLORIDE

Brand Name : EXXUA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 36.3MG BASE

Approval Date : 2023-09-22

Application Number : 21164

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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FABRE KRAMER

U.S.A
AGGSpend
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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

Brand Name : EXXUA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 54.5MG BASE

Approval Date : 2023-09-22

Application Number : 21164

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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FABRE KRAMER

U.S.A
AGGSpend
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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

Brand Name : EXXUA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 72.6MG BASE

Approval Date : 2023-09-22

Application Number : 21164

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   

Impressions: 8051

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

NEWS #PharmaBuzz

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Patents & EXCLUSIVITIES

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US Patents

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

US Patent Number : 7538116

Drug Substance Claim :

Drug Product Claim :

Application Number : 21164

Patent Use Code : U-3699

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-09-02

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

US Patent Number : 7538116

Drug Substance Claim :

Drug Product Claim :

Application Number : 21164

Patent Use Code : U-3699

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-09-02

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

US Patent Number : 7538116

Drug Substance Claim :

Drug Product Claim :

Application Number : 21164

Patent Use Code : U-3699

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-09-02

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

US Patent Number : 7538116

Drug Substance Claim :

Drug Product Claim :

Application Number : 21164

Patent Use Code : U-3699

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-09-02

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US Exclusivities

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-09-22

Application Number : 21164

Product Number : 1

Exclusivity Details :

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-09-22

Application Number : 21164

Product Number : 2

Exclusivity Details :

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-09-22

Application Number : 21164

Product Number : 3

Exclusivity Details :

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FABRE KRAMER

U.S.A
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GEPIRONE HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-09-22

Application Number : 21164

Product Number : 4

Exclusivity Details :

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ABOUT THIS PAGE

Looking for 83928-66-9 / Gepirone API manufacturers, exporters & distributors?

Gepirone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Gepirone 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 Gepirone manufacturer or Gepirone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gepirone manufacturer or Gepirone supplier.

PharmaCompass also assists you with knowing the Gepirone API Price utilized in the formulation of products. Gepirone API Price is not always fixed or binding as the Gepirone Price is obtained through a variety of data sources. The Gepirone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gepirone

Synonyms

Gepirone hcl, Travivo, Gepirone hydrochloride [usan], 83928-66-9, Tgfk07ad, Bmy 13805-1

Cas Number

83928-66-9

Unique Ingredient Identifier (UNII)

80C9L8EP6V

GEPIRONE HYDROCHLORIDE Manufacturers

A GEPIRONE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GEPIRONE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates GEPIRONE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GEPIRONE 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.

click here to find a list of GEPIRONE HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

GEPIRONE HYDROCHLORIDE Suppliers

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

click here to find a list of GEPIRONE HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

GEPIRONE HYDROCHLORIDE USDMF

A GEPIRONE HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of GEPIRONE HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of GEPIRONE HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as GEPIRONE HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A GEPIRONE HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. GEPIRONE HYDROCHLORIDE USDMF includes data on GEPIRONE HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GEPIRONE HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of GEPIRONE HYDROCHLORIDE suppliers with USDMF on PharmaCompass.

GEPIRONE 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 GEPIRONE HYDROCHLORIDE as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of GEPIRONE HYDROCHLORIDE suppliers with NDC on PharmaCompass.

GEPIRONE HYDROCHLORIDE GMP

GEPIRONE 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 GEPIRONE 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 GEPIRONE HYDROCHLORIDE GMP manufacturer or GEPIRONE HYDROCHLORIDE GMP API supplier for your needs.

GEPIRONE HYDROCHLORIDE CoA

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

GEPIRONE HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each GEPIRONE 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.

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