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Chemistry

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Also known as: 1208319-27-0, Oclacitinib (maleate), 1640292-55-2, Apoquel, Oclacitinib maleate [usan], Oclacitinib maleate(pf-03394197)
Molecular Formula
C19H27N5O6S
Molecular Weight
453.5  g/mol
InChI Key
VQIGDTLRBSNOBV-BTJKTKAUSA-N
FDA UNII
VON733L42A

Oclacitinib Maleate
1 2D Structure

Oclacitinib Maleate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(Z)-but-2-enedioic acid;N-methyl-1-[4-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]cyclohexyl]methanesulfonamide
2.1.2 InChI
InChI=1S/C15H23N5O2S.C4H4O4/c1-16-23(21,22)9-11-3-5-12(6-4-11)20(2)15-13-7-8-17-14(13)18-10-19-15;5-3(6)1-2-4(7)8/h7-8,10-12,16H,3-6,9H2,1-2H3,(H,17,18,19);1-2H,(H,5,6)(H,7,8)/b;2-1-
2.1.3 InChI Key
VQIGDTLRBSNOBV-BTJKTKAUSA-N
2.1.4 Canonical SMILES
CNS(=O)(=O)CC1CCC(CC1)N(C)C2=NC=NC3=C2C=CN3.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CNS(=O)(=O)CC1CCC(CC1)N(C)C2=NC=NC3=C2C=CN3.C(=C\C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
VON733L42A
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Apoquel

2. Oclacitinib

2.3.2 Depositor-Supplied Synonyms

1. 1208319-27-0

2. Oclacitinib (maleate)

3. 1640292-55-2

4. Apoquel

5. Oclacitinib Maleate [usan]

6. Oclacitinib Maleate(pf-03394197)

7. Pf-03394197-11

8. Von733l42a

9. Oclacitinib Maleate (usan)

10. (z)-but-2-enedioic Acid;n-methyl-1-[4-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]cyclohexyl]methanesulfonamide

11. N-methyl(trans-4-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)cyclohexyl) Methanesulfonamide (2z)-2-butenedioate

12. Unii-von733l42a

13. Oclacitinib(maleate)

14. Pf-03394197 Maleate

15. Schembl260868

16. Chembl2105739

17. Oclacitinib Maleate [mi]

18. Schembl19205843

19. Amy19492

20. Ex-a3658

21. Hy-13577a

22. S8195

23. Ccg-269269

24. Cs-7611

25. Ac-32980

26. Bs-44681

27. D10142

28. D84061

29. Oclacitinib Maleate (ema Epar: Veterinary)

30. Pf 03394197-11

31. Q27291934

32. Cyclohexanemethanesulfonamide, N-methyl-4-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4- Ylamino)-, Trans-, (2z)-2-butenedioate (1:?)

33. N-methyl-1-((1r,4r)-4-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide Maleate

34. N-methyl-1-(trans-4-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide Maleate(1:x)

2.4 Create Date
2010-03-08
3 Chemical and Physical Properties
Molecular Weight 453.5 g/mol
Molecular Formula C19H27N5O6S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count10
Rotatable Bond Count7
Exact Mass453.16820477 g/mol
Monoisotopic Mass453.16820477 g/mol
Topological Polar Surface Area174 Ų
Heavy Atom Count31
Formal Charge0
Complexity606
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

- Treatment of pruritus associated with allergic dermatitis in dogs.

- Treatment of clinical manifestations of atopic dermatitis in dogs.


5 Pharmacology and Biochemistry
5.1 ATC Code

QD11AH90


NDC API

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01

Siegfried AG

Switzerland
COMPAMED
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Siegfried AG

Switzerland
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COMPAMED
Not Confirmed

OCLACITINIB MALEATE

NDC Package Code : 17205-097

Start Marketing Date : 2019-04-12

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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02

Zoetis Inc.

U.S.A
COMPAMED
Not Confirmed
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Zoetis Inc.

U.S.A
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COMPAMED
Not Confirmed

OCLACITINIB MALEATE

NDC Package Code : 54771-1344

Start Marketing Date : 2020-03-25

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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VMF

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01

Zoetis Inc

U.S.A
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Chinacoat
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02

Zoetis Inc

U.S.A
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Chinacoat
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03

Zoetis Inc

U.S.A
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Chinacoat
Not Confirmed
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Listed Suppliers

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01

  • fda
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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Oclacitinib Maleate

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
Rochem

02

  • fda
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Virtual BoothQingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.

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Oclacitinib Maleate

About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and ...

Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and advanced intermediates, and also offer high-quality CDMO/CMO services for small-molecule drugs. Qingmu has been inspected and approved by global regulatory authorities such as the US FDA, Korea MFDS, and China NMPA, and has earned client approvals across the U.S., Europe, Japan, and China. With strong technical capabilities and a commitment to international quality standards, we support customers from early development through to commercial supply.
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03

Seqens

France
  • fda
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  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Oclacitinib Maleate

About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...

Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists in the development, scale-up and manufacturing of drug substances from pre-clinical to commercial stages. Seqens boasts a vast portfolio of APIs and proprietary products while also developing custom solutions and ingredients for the healthcare, electronics and cosmetics industries. It operates 16 industrial plants and 9 R&D centers worldwide. Seqens possesses technologies that enable it to produce complex molecules to meet both small- and large-scale demands.
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Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

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Oclacitinib

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulations. With 23 years of production experience, the company operates 6 GMP-compliant workshops, achieving a monthly capacity of 100 tons to meet cGMP requirements. Currently, the factory has registered 21 APIs in NMPA, filed 4 US-DMFs, and applied for 9 CEPs, while successfully passing audits by MFDS, US FDA, and global customers.
Shandong Chenghui Shuangda Pharmaceutical

05

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Virtual BoothCosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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Oclacitinib Maleate

About the Company : Cosma S.p.A., part of the CFM Group along with AMSA and Clarochem Ireland, is the group’s largest manufacturing site, located in Bergamo, Italy. With a 130,000L glass-lined react...

Cosma S.p.A., part of the CFM Group along with AMSA and Clarochem Ireland, is the group’s largest manufacturing site, located in Bergamo, Italy. With a 130,000L glass-lined reaction volume and over 300 tons of annual API output, Cosma exports more than half of its production to the U.S. and supports leading global pharmaceutical and animal health companies. Together with AMSA, specializing in small- to medium-volume APIs, and Clarochem Ireland, offering 60,000L capacity for contract manufacturing and back-integration, the CFM Group ensures scale, quality, and reliability worldwide.
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Oclacitinib Maleate

About the Company : Alivira Animal Health Limited has emerged as India's largest and 1st Global integrated animal health company specialising in manufacturing of Active Pharmaceutical Ingredients (API...

Alivira Animal Health Limited has emerged as India's largest and 1st Global integrated animal health company specialising in manufacturing of Active Pharmaceutical Ingredients (API) and Finished Dosage Formulations (FDF).Our logotype is inspired by nature and its different forms and shapes. From a microscopic view to the skin texture, footprint of a chosen animal. The circular shape evokes the idea of protection and control. It’s a closed and perfect shape that is naturally balanced, reminiscing the brand idea “Animals source of health.
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Almelo

India
COMPAMED
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Almelo

India
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Oclacitinib Maleate

About the Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse product portfolio cou...

Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse product portfolio coupled with innovative R&D, Almelo boasts of having various reputed domestic and multi-national companies as its customers.
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Oclacitinib Maleate

About the Company : NGL Fine-Chem Ltd is a manufacturer of pharmaceuticals and intermediates for usage in veterinary and human health. We cater to various global companies to custom manufacture high q...

NGL Fine-Chem Ltd is a manufacturer of pharmaceuticals and intermediates for usage in veterinary and human health. We cater to various global companies to custom manufacture high quality pharmaceuticals with reliability and flexibility. Our business is modelled around the changing customer demands and our ability to offer value-added innovative solutions to meet and even exceed these demands.
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Sterling Spa

Italy
COMPAMED
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Sterling Spa

Italy
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Oclacitinib Maleate

About the Company : The Quality Assurance department is the Guardian of Quality within the Company. We have a team dedicated to identifying and implementing new ICH guidelines. Our team is prepared ...

The Quality Assurance department is the Guardian of Quality within the Company. We have a team dedicated to identifying and implementing new ICH guidelines. Our team is prepared to obtain quality objectives which have been universally recognized by Inspection Authorities and the most important Pharmaceutical Companies from around the globe. This system is periodically verified through internal, national and international inspectors who have been able to recognize the high level obtained by the system and the actual achievement of quality objectives multiple times. Sterling has been inspected three times by FDA .
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Oclacitinib

About the Company : Zenfold Sustainable Technologies (ZST) is a specialty and fine chemicals company, established in 2021. Our advanced technological capabilities and state-of-the-art infrastructure a...

Zenfold Sustainable Technologies (ZST) is a specialty and fine chemicals company, established in 2021. Our advanced technological capabilities and state-of-the-art infrastructure allow us to provide the entire gamut of services involved in manufacturing and contract research — from process development to scaling up. We offer a wide range of APIs and intermediates to customers across industries. We differentiate ourselves in the market with our unique hybridized approach to manufacturing, built on our three core technological platforms: Synthetic Biology, Biotransformation, and Green Chemistry.
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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706034600,"product":"OCLACITINIB MALEATE(PHARMACEUTICAL RAW MATERIAL AS PER COMMERCIAL INV NO:APL\/038\/23-24 DATE:24.01.2024)","address":"PLOT.NO.A-39 & B-11, ROAD.NO.7, IDA KUKATPALLY","city":"HYDERABAD","supplier":"ALMELO PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"RESEARCH AND PRODUCTION CO","customerCountry":"RUSSIA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"4620","totalValueFC":"16553.3","currency":"INR","unitRateINR":4585.916666666667,"date":"24-Jan-2024","totalValueINR":"1375775","totalValueInUsd":"16553.3","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"6993858","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT.NO.A-39 & B-11, ROAD.NO.7, IDA KUKATPALLY, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707157800,"product":"CS-P-02276 \/ OCLACITINIB MALEATE","address":"413 LAXMI MALL LAXMI INDL,","city":"MUMBAI","supplier":"CLEARSYNTH LABS LTD","supplierCountry":"INDIA","foreign_port":"MINSK","customer":"RUBIKON LTD","customerCountry":"BELARUS","quantity":"0.00","actualQuantity":"0.5","unit":"GMS","unitRateFc":"133000","totalValueFC":"621.8","currency":"INR","unitRateINR":103193.86,"date":"06-Feb-2024","totalValueINR":"51596.93","totalValueInUsd":"621.8","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"7309961","productDescription":"API","marketType":"REGULATED MARKET","country":"BELARUS","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"413 LAXMI MALL LAXMI INDL,, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"API-OCLACITINIB MALEATE","address":"PLOT.NO.A-39 & B-11, ROAD.NO.7, IDA KUKATPALLY","city":"HYDERABAD","supplier":"ALMELO PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"ICARGO INTERNATIONAL LOGISTIK","customerCountry":"GERMANY","quantity":"0.55","actualQuantity":"0.55","unit":"KGS","unitRateFc":"51000","totalValueFC":"27688.7","currency":"USD","unitRateINR":4230150.7454545451,"date":"25-Oct-2024","totalValueINR":"2326582.91","totalValueInUsd":"27688.7","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5127590","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT.NO.A-39 & B-11, ROAD.NO.7, IDA KUKATPALLY, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743791400,"product":"OCLACITINIB MALEATE","address":"PLOT.NO.A-39 B-11, ROAD.NO.7, IDA","city":"HYDERABAD","supplier":"ALMELO PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"SHEN CHEN PHARMACEUTICALS INC","customerCountry":"TAIWAN","quantity":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"21","totalValueFC":"4134.6","currency":"USD","unitRateINR":1769.6500000000001,"date":"05-Apr-2025","totalValueINR":"353930","totalValueInUsd":"4134.6","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9709135","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT.NO.A-39 B-11, ROAD.NO.7, IDA, HYDERABAD","customerAddress":""}]
24-Jan-2024
05-Apr-2025
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INTERMEDIATE SUPPLIERS

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01

Almelo

India
The Pharmacy Technology
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Almelo

India
The Pharmacy Technology
Not Confirmed
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CAS Number : CAS-479633-63-1

End Use API : Oclacitinib Maleate

About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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Listed Dossiers

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01

  • fda
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Oclacitinib Maleate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 3.6MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

01

  • fda
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  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Packaging :

Regulatory Info :

Oclacitinib Maleate

Dosage : Tablet

Dosage Strength : 3.6MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

02

  • fda
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Oclacitinib Maleate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5.4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

02

  • fda
  • EDQM
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Digital Content Digital Content

Packaging :

Regulatory Info :

Oclacitinib Maleate

Dosage : Tablet

Dosage Strength : 5.4MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

03

  • fda
  • EDQM
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Regulatory Info :

Registration Country : India

Oclacitinib Maleate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 16MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

03

  • fda
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Packaging :

Regulatory Info :

Oclacitinib Maleate

Dosage : Tablet

Dosage Strength : 16MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

04

COMPAMED
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Oclacitinib Maleate

Brand Name : Oclacitinib

Dosage Form : Chewable Tablet

Dosage Strength : 3.6MG

Packaging :

Approval Date :

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Regulatory Info :

Registration Country : China

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Oclacitinib Maleate

Dosage : Chewable Tablet

Dosage Strength : 3.6MG

Brand Name : Oclacitinib

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Application Number :

Registration Country : China

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Oclacitinib Maleate

Brand Name : Oclacitinib

Dosage Form : Chewable Tablet

Dosage Strength : 5.4MG

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Regulatory Info :

Registration Country : China

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Oclacitinib Maleate

Dosage : Chewable Tablet

Dosage Strength : 5.4MG

Brand Name : Oclacitinib

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Application Number :

Registration Country : China

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Oclacitinib Maleate

Brand Name : Oclacitinib

Dosage Form : Chewable Tablet

Dosage Strength : 5.4MG

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Regulatory Info :

Registration Country : China

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Oclacitinib Maleate

Dosage : Chewable Tablet

Dosage Strength : 5.4MG

Brand Name : Oclacitinib

Approval Date :

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Registration Country : China

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ABOUT THIS PAGE

Looking for 1640292-55-2 / Oclacitinib Maleate API manufacturers, exporters & distributors?

Oclacitinib Maleate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Oclacitinib Maleate

Synonyms

1208319-27-0, Oclacitinib (maleate), 1640292-55-2, Apoquel, Oclacitinib maleate [usan], Oclacitinib maleate(pf-03394197)

Cas Number

1640292-55-2

Unique Ingredient Identifier (UNII)

VON733L42A

Oclacitinib Maleate Manufacturers

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

Oclacitinib Maleate Suppliers

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

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

Oclacitinib Maleate 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 Oclacitinib Maleate as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Oclacitinib Maleate suppliers with NDC on PharmaCompass.

Oclacitinib Maleate GMP

Oclacitinib Maleate 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 Oclacitinib Maleate 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 Oclacitinib Maleate GMP manufacturer or Oclacitinib Maleate GMP API supplier for your needs.

Oclacitinib Maleate CoA

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

Oclacitinib Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Oclacitinib Maleate 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.

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