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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

API REF. PRICE (USD/KG)

MARKET PLACE

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FDF

FINISHED DOSAGE FORMULATIONS

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FDA Orange Book

FDA (Orange Book)

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Europe

Europe

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Australia

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South Africa

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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


API SUPPLIERS

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01

Rochem International Inc

U.S.A

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

  • fda
  • EDQM
  • WHO-GMP

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

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

02

Seqens

France

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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Flag France
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Seqens Company Banner

03

Suanfarma

Spain

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

Flag Spain
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Suanfarma

04

Supriya Lifescience

India

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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Supriya

05

Alivira Animal Health

India

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

Antibody Engineering
Not Confirmed
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Alivira Animal Health

India

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

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Antibody Engineering
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

Sichuan Qingmu Pharmaceutical

China

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

Antibody Engineering
Not Confirmed
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07

Sterling Spa

Italy

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

Antibody Engineering
Not Confirmed
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08

Almelo

India

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

Antibody Engineering
Not Confirmed
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09

Shanghai Hope Chem

China

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

Antibody Engineering
Not Confirmed
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10

Zenfold Sustainable Technologies

India

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

Antibody Engineering
Not Confirmed
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NDC API

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01

Siegfried AG

Switzerland
Antibody Engineering
Not Confirmed
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Siegfried AG

Switzerland
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Antibody Engineering
Not Confirmed

OCLACITINIB MALEATE

NDC Package Code : 17205-097

Start Marketing Date : 2019-04-12

End Marketing Date : 2024-12-31

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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Antibody Engineering
Not Confirmed

02

Zoetis Inc

U.S.A
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Antibody Engineering
Not Confirmed

03

Zoetis Inc

U.S.A
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Antibody Engineering
Not Confirmed
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Listed Suppliers

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01

  • fda
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  • WHO-GMP

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

Flag U.S.A
Digital Content Digital Content

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

Seqens

France
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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Digital Content Digital Content

Oclacitinib Maleate

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.
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03

Suanfarma

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

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Digital Content Digital Content

Oclacitinib Maleate

About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...

Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
Suanfarma

04

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Oclacitinib Maleate

About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...

Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Supriya follows industry standards and constantly improves to deliver quality products. Its facility is 47,000 square meters with dedicated areas for warehouse, QA, QC, R&D, production and finished products. The current capacity is 550 KL, with plans to expand to over 1000 KL by 2024. Supriya has 14 active USDMFs, 8 active CEPs, strong R&D and compliant facilities worldwide. Supriya works with innovators, generic companies, and as a CMO.
Supriya

05

Antibody Engineering
Not Confirmed
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Antibody Engineering
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Oclacitinib

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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06

Almelo

India
Antibody Engineering
Not Confirmed
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Almelo

India
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Antibody Engineering
Not Confirmed

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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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
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Oclacitinib

About the Company : Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Current...

Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Currently, they have exclusive partnerships with multiple, state-of-the-art and GMP-compliant manufacturers in China and abroad to service our esteemed partners for competitive, long-term & stable supplies. The main products are APIs and intermediates of antiviral drug substances and anti-inflammatory, analgesic, and non-steroidal pharmaceuticals.
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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
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Oclacitinib Maleate

About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd, is a FDA approved cGMP factory in China, focusing on APIs’ production. The products are mainly Oncology APIs, Cardiovascular APIs, and Vet...

Sichuan Qingmu Pharmaceutical Co., Ltd, is a FDA approved cGMP factory in China, focusing on APIs’ production. The products are mainly Oncology APIs, Cardiovascular APIs, and Veterinary APIs, such as Bisoprolol, Dabigatran, Lenvatinib and Fluralaner with DMFs available. Some products are certified with CEP. Also with our mother factory, we can provide CDMO production from intermediates, APIs to formulations.
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09

Sterling Spa

Italy
Antibody Engineering
Not Confirmed
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Sterling Spa

Italy
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Antibody Engineering
Not Confirmed

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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10

Antibody Engineering
Not Confirmed
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Antibody Engineering
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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","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"RESEARCH AND PRODUCTION COMPANY","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":"LESS REGULATED MARKET","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":1709317800,"product":"CS-P-02276 \/ OCLACITINIB MALEATE","address":"413 LAXMI MALL LAXMI INDL,","city":"MUMBAI","supplier":"CLEARSYNTH LABS LIMITED","supplierCountry":"INDIA","foreign_port":"MINSK","customer":"RUBIKON LTD","customerCountry":"BELARUS","quantity":"0.00","actualQuantity":"0.5","unit":"GMS","unitRateFc":"133000","totalValueFC":"621.4","currency":"INR","unitRateINR":103193.86,"date":"02-Mar-2024","totalValueINR":"51596.93","totalValueInUsd":"621.4","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"8013287","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","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"ICARGO INTERNATIONAL LOGISTIK","customerCountry":"GERMANY","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"51000","totalValueFC":"5034.3","currency":"USD","unitRateINR":4230148.6999999993,"date":"25-Oct-2024","totalValueINR":"423014.87","totalValueInUsd":"5034.3","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":""}]
24-Jan-2024
25-Oct-2024
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INTERMEDIATES SUPPLIERS

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01

Almelo

India
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Almelo

India
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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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Oclacitinib Maleate

Dosage : Tablet

Dosage Strength : 3.6MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

02

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Oclacitinib Maleate

Dosage : Tablet

Dosage Strength : 16MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya
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