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Synopsis

Synopsis

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Chemistry

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Also known as:
Molecular Formula
C18H19ClN4
Molecular Weight
326.8  g/mol
InChI Key
ZUXABONWMNSFBN-UHFFFAOYSA-N

Clozapine
1 2D Structure

Clozapine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-chloro-6-(4-methylpiperazin-1-yl)-5H-benzo[b][1,4]benzodiazepine
2.1.2 InChI
InChI=1S/C18H19ClN4/c1-22-8-10-23(11-9-22)18-14-4-2-3-5-15(14)20-16-7-6-13(19)12-17(16)21-18/h2-7,12,21H,8-11H2,1H3
2.1.3 InChI Key
ZUXABONWMNSFBN-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1CCN(CC1)C2=C3C=CC=CC3=NC4=C(N2)C=C(C=C4)Cl
2.1.5 Isomeric SMILES
CN1CCN(CC1)C2=C3C=CC=CC3=NC4=C(N2)C=C(C=C4)Cl
2.2 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 326.8 g/mol
Molecular Formula C18H19ClN4
XLogP33.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count1
Exact Mass326.1298243 g/mol
Monoisotopic Mass326.1298243 g/mol
Topological Polar Surface Area30.9 A^2
Heavy Atom Count23
Formal Charge0
Complexity584
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameClozapine
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelVERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength200mg; 100mg; 25mg; 50mg; 12.5mg
Market StatusPrescription
CompanyIvax Sub Teva Pharms; Sun Pharm Inds; Mylan

2 of 6  
Drug NameClozaril
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelCLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength100mg; 25mg
Market StatusPrescription
CompanyNovartis

3 of 6  
Drug NameFazaclo odt
Active IngredientClozapine
Dosage FormTablet, orally disintegrating
RouteOral
Strength200mg; 100mg; 25mg; 150mg; 12.5mg
Market StatusPrescription
CompanyJazz Pharms Iii

4 of 6  
Drug NameClozapine
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelVERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength200mg; 100mg; 25mg; 50mg; 12.5mg
Market StatusPrescription
CompanyIvax Sub Teva Pharms; Sun Pharm Inds; Mylan

5 of 6  
Drug NameClozaril
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelCLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength100mg; 25mg
Market StatusPrescription
CompanyNovartis

6 of 6  
Drug NameFazaclo odt
Active IngredientClozapine
Dosage FormTablet, orally disintegrating
RouteOral
Strength200mg; 100mg; 25mg; 150mg; 12.5mg
Market StatusPrescription
CompanyJazz Pharms Iii

API SUPPLIERS

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01

LGM Pharma

U.S.A

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

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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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02

Cohance Lifesciences

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Digital Content Digital Content
USDMF arrow-down CEP/COS Inactive-api JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
Cohance

03

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 AU arrow-down AUDIT
HRV Global Life Sciences

04

Mankind Pharma

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

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USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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05

SMS Pharmaceuticals

India

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

ACS GCI
Not Confirmed
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SMS Pharmaceuticals

India

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

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ACS GCI
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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06

Aurore Life Sciences

India

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

ACS GCI
Not Confirmed
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Aurore Life Sciences

India

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

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ACS GCI
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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07

Shouguang Fukang Pharmaceutical Co...

China

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

ACS GCI
Not Confirmed
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Shouguang Fukang Pharmaceutical Co...

China

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

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ACS GCI
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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08

SHANGHAI ZHONGXI SUNVE PHARMACEUTI...

China

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

ACS GCI
Not Confirmed
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SHANGHAI ZHONGXI SUNVE PHARMACEUTI...

China

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

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ACS GCI
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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09

Global Calcium

India

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

ACS GCI
Not Confirmed
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Global Calcium

India

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

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Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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10

Wuhan Shiji Pharmaceutical

China

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

ACS GCI
Not Confirmed
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Wuhan Shiji Pharmaceutical

China

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

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USDMF

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2019-01-29

Pay. Date : 2018-12-07

DMF Number : 31999

Submission : 2017-08-24

Status : Active

Type : II

Cohance

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

Flag India
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37540

Submission : 2023-02-01

Status : Active

Type : II

Company Banner

03

Arevipharma Gmbh

Germany

USDMF

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ACS GCI
Not Confirmed

04

ACS GCI
Not Confirmed

04

ACS GCI
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-04

Pay. Date : 2013-09-30

DMF Number : 11692

Submission : 1995-10-03

Status : Active

Type : II

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05

Medichem Sa

Spain

USDMF

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ACS GCI
Not Confirmed

07

ACS GCI
Not Confirmed

08

ACS GCI
Not Confirmed

08

ACS GCI
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-29

Pay. Date : 2013-09-25

DMF Number : 25182

Submission : 2011-08-03

Status : Active

Type : II

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09

ACS GCI
Not Confirmed

09

10

Huizhou Dongjiang Pharmaceutical Fac...

Country

USDMF

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ACS GCI
Not Confirmed

10

Huizhou Dongjiang Pharmaceutical Fac...

Country
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ACS GCI
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12873

Submission : 1998-02-22

Status : Inactive

Type : II

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CEP/COS

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  • fda
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Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Digital Content Digital Content
R0-CEP 2018-192 - Rev 01
Withdrawn by Holder
Chemical
2021-02-12
2025-03-31
1191
Cohance

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Certificate Number : R0-CEP 2018-192 - Rev 01

Status : Withdrawn by Holder

Issue Date : 2021-02-12

Type : Chemical

Substance Number : 1191

Cohance

02

ACS GCI
Not Confirmed
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Certificate Number : R1-CEP 2006-205 - Rev 01

Status : Withdrawn by Holder

Issue Date : 2015-11-05

Type : Chemical

Substance Number : 1191

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05

ACS GCI
Not Confirmed
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Certificate Number : R1-CEP 2005-128 - Rev 03

Status : Valid

Issue Date : 2022-05-31

Type : Chemical

Substance Number : 1191

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08

ACS GCI
Not Confirmed
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ACS GCI
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Certificate Number : R1-CEP 2012-006 - Rev 00

Status : Valid

Issue Date : 2018-04-12

Type : Chemical

Substance Number : 1191

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ACS GCI
Not Confirmed
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ACS GCI
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Certificate Number : CEP 2008-234 - Rev 02

Status : Valid

Issue Date : 2024-07-25

Type : Chemical

Substance Number : 1191

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10

ACS GCI
Not Confirmed
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ACS GCI
Not Confirmed

Certificate Number : R1-CEP 2010-087 - Rev 01

Status : Valid

Issue Date : 2019-04-23

Type : Chemical

Substance Number : 1191

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Listed Suppliers

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01

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Flag U.S.A
Digital Content Digital Content

Clozapine

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

02

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Clozapine

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

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

Flag India
Digital Content Digital Content

Clozapine

About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...

Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical company in 1995. Today, we have 11,000 employees and are heading towards a turnover of INR 50000 million. Our vast network includes 50 C&F agents and 7500+ stockists. We provide a wide range of products – Antibiotic, Antifungal, NSAIDs, Gastrointestinal, Anthelmintic, Cardiovascular, Dermal, Erectile Dysfunction, and several other categories – across the nation.
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04

ACS GCI
Not Confirmed
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Clozapine

About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...

Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with vast experience across the pharmaceutical value chain, the company is on a mission to become the most preferred partner for pharmaceuticals. At Aurore, we aim to push the boundaries to manufacture and deliver high quality products that can be relied upon by both customers and regulators. Our thrust on rapidly adding capabilities have led us to acquire, integrate and expand our reach across the geographies.
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05

ACS GCI
Not Confirmed
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Clozapine

About the Company : As an EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979 as Calcium Ind...

As an EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979 as Calcium India. Today, Global Calcium represents the true hallmark of quality when it comes to pharmaceutical products. Global Calcium is backed by an excellent management team comprising of industry specialists, technocrats, entrepreneurs and business specialists bringing in strong domain expertise in fields such as investment banking, to consulting to behind the scenes pure sciences.
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06

ACS GCI
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Clozapine

About the Company : JIN DUN Medical Research Institute is affiliated to Shanghai JIN DUN Industrial Co., Ltd., headquartered in Shanghai, adjacent to Hongqiao High-speed Railway Station and Hongqiao I...

JIN DUN Medical Research Institute is affiliated to Shanghai JIN DUN Industrial Co., Ltd., headquartered in Shanghai, adjacent to Hongqiao High-speed Railway Station and Hongqiao International airport. JIN DUN Medical Research Institute is committed to providing pharmaceutical intermediates and raw materials with the purpose of innovative drug research. Customized R&D and customized production services.
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Medichem S.A

Spain
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Not Confirmed
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Medichem S.A

Spain
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Clozapine

About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.
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ACS GCI
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Clozapine

About the Company : Medilux Laboratories has been providing quality back-end support to the pharmaceutical industry since our inception in 1988. Our resources are dedicated to promoting better health ...

Medilux Laboratories has been providing quality back-end support to the pharmaceutical industry since our inception in 1988. Our resources are dedicated to promoting better health through products that offer superior value. Located in Pithampur, Madhya Pradesh, Medilux Laboratories is committed to strategic research, delivering a complex range of globally benchmarked chemistries. Our products and services are rapidly making strides in the global pharmaceutical space, giving us the impetus to constantly strive for excellence and provide quality customer service.
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09

ACS GCI
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Clozapine

About the Company : Smilax Laboratories Limited is a research-driven, vertically integrated pharmaceutical company manufacturing Active Pharmaceutical Ingredients, API Intermediates and NDDS/Pellets f...

Smilax Laboratories Limited is a research-driven, vertically integrated pharmaceutical company manufacturing Active Pharmaceutical Ingredients, API Intermediates and NDDS/Pellets for the generics market across the world. Set up in 2005, Smilax has emerged a reliable supplier of generic products in the global market today. Set up in 2005, Smilax has emerged a reliable supplier of generic products in the global market today.Set up in 2005, Smilax has emerged a reliable supplier of generic products in the global market today. Smilax manufactures APIs and API Intermediates at its state-of-the-art manufacturing facilities located at Hyderabad, Telangana and Visakhapatnam, Andhra Pradesh, India. Supported by a highly qualified and competent technical team, and endowed with strengths in research and development, Smilax continues to expand its presence in the world of pharmaceuticals.
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ACS GCI
Not Confirmed
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Clozapine

About the Company : SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a sin...

SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a single facility - single product manufacturing company in 1990 grew to be a multi-location group having product list spreading across an array of therapeutic segments. SMS was given the export house status in the year 1997-98. SMS is currently a listed company having ever appreciating international and domestic customer base.
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API Reference Price

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GUJARAT","supplier":"NANJING SHUODI TRADING COMPANY LIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"TORRENT PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"177","totalValueFC":"7135.8","currency":"USD","unitRateINR":"15452.1","date":"22-Mar-2025","totalValueINR":"618084","totalValueInUsd":"7135.8","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"9036274","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ROOM 427, BLDG.,1 TIANZHENG TAOYUAN FU, REHE SOUTH ROAD, NANJING CHINA 210011 CHINA","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742754600,"product":"CLOZAPINE IP\/BP\/USP CLOZAPINE IP\/BP\/USP","address":"13,VITHALDAS ROAD,BULAKHIDAS","city":"MUMBAI,MAHARASHTRA","supplier":"BRILLIANT PHARMACEUTICAL LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"MEDI PHARMA DRUG HOUSE","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"70.5","totalValueFC":"35532.8","currency":"USD","unitRateINR":"6155.5","date":"24-Mar-2025","totalValueINR":"3077761.5","totalValueInUsd":"35532.8","indian_port":"JNPT","hs_no":"29339990","bill_no":"9071811","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"OFFICE F 32\/F PLAZA 88 NO 88 YEUNG UK ROAD TSUEN WAN NT HONG KONG, SDNF CHINA","customerAddress":"13,VITHALDAS ROAD,BULAKHIDAS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744309800,"product":"CLOZAPINE (2017.75 KGS)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CAMBREX PROFARMACO MILANO SRL","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"2017.75","actualQuantity":"2017.75","unit":"KGS","unitRateFc":"390","totalValueFC":"796099","currency":"USD","unitRateINR":"33774","date":"11-Apr-2025","totalValueINR":"68147488.5","totalValueInUsd":"796099","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29335990","bill_no":"9420331","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILANO","supplierAddress":"VIA CURIEL 34 20067 PAULLO MILANO Italy SDNF Italy","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747074600,"product":"CLOZAPINE (FOR PHARMACEUTICAL USE ONLY) CLOZAPINE (FOR PHARMACEUTICAL USE ONLY)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MEDICHEM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"1136.30","actualQuantity":"1136.3","unit":"KGS","unitRateFc":"250","totalValueFC":"285239.8","currency":"USD","unitRateINR":"21387.5","date":"13-May-2025","totalValueINR":"24302616.25","totalValueInUsd":"285239.8","indian_port":"JNPT","hs_no":"29339990","bill_no":"2036839","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6,08970 SANT JOA N DESPIBARCELONA SDNF SPAIN","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748543400,"product":"CLOZAPINE IP\/USP CLOZAPINE IP\/USP","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"88","totalValueFC":"4461.9","currency":"N\/A","unitRateINR":"7603.2","date":"30-May-2025","totalValueINR":"380160","totalValueInUsd":"4461.9","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"2383104","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEUNG UK ROAD, TSUEN WAN, NT HONG KONG, CHINA CN","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"}]
29-Jan-2022
30-May-2025
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Drugs in Development

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Details:

Tanner to distribute Versacloz in areas outside of the U.S where the product is not yet registered. Versacloz is indicated for the treatment of severely ill patients with schizophrenia who fail to respond to standard antipsychotic treatment.


Lead Product(s): Clozapine

Therapeutic Area: Psychiatry/Psychology Brand Name: Versacloz

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Tasmanian Alkaloids Pty Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 22, 2020

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01

ACS GCI
Not Confirmed
ACS GCI
Not Confirmed

Details : Tanner to distribute Versacloz in areas outside of the U.S where the product is not yet registered. Versacloz is indicated for the treatment of severely ill patients with schizophrenia who fail to respond to standard antipsychotic treatment.

Product Name : Versacloz

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

June 22, 2020

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 100MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 50MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - SUSPENSION;ORAL - 50MG/ML

USFDA APPLICATION NUMBER - 203479

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21590

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Patents & EXCLUSIVITIES

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US Patents

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01

DOUGLAS PHARMS

New Zealand
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEnd-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

Patent Expiration Date : 2028-05-01

CLOZAPINE

US Patent Number : 8057811

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 203479

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-01

Douglas CDMO
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ABOUT THIS PAGE

Looking for / Clozapine API manufacturers, exporters & distributors?

Clozapine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Clozapine

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Manufacturers

A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex, including repackagers and relabelers. The FDA regulates Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Suppliers

A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex supplier is an individual or a company that provides Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex active pharmaceutical ingredient (API) or Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex finished formulations upon request. The Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers may include Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex API manufacturers, exporters, distributors and traders.

click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex USDMF

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

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

click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with USDMF on PharmaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JDMF

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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Drug Master File in Japan (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JDMF) empowers Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JDMF during the approval evaluation for pharmaceutical products. At the time of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with JDMF on PharmaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Drug Master File in Korea (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex. The MFDS reviews the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex KDMF as part of the drug registration process and uses the information provided in the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex KDMF to evaluate the safety and efficacy of the drug.

After submitting a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with KDMF on PharmaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP

A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP of the European Pharmacopoeia monograph is often referred to as a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Certificate of Suitability (COS). The purpose of a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex to their clients by showing that a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP has been issued for it. The manufacturer submits a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP holder for the record. Additionally, the data presented in the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex DMF.

A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with CEP (COS) on PharmaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex WC

A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex written confirmation (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex WC) is an official document issued by a regulatory agency to a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex manufacturer, verifying that the manufacturing facility of a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex APIs or Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex finished pharmaceutical products to another nation, regulatory agencies frequently require a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex WC (written confirmation) as part of the regulatory process.

click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with Written Confirmation (WC) on PharmaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with NDC on PharmaCompass.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex GMP

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex GMP manufacturer or Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex GMP API supplier for your needs.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CoA

A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CoA (Certificate of Analysis) is a formal document that attests to Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex's compliance with Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex specifications and serves as a tool for batch-level quality control.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CoA mostly includes findings from lab analyses of a specific batch. For each Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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.

Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex may be tested according to a variety of international standards, such as European Pharmacopoeia (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex EP), Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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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