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Chemistry

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Also known as: 78213-16-8, Diclofenac (diethylamine), Diclofenac diethylammonium salt, 6tgq35z71k, 2-[2-(2,6-dichloroanilino)phenyl]acetic acid;n-ethylethanamine, Voltarol
Molecular Formula
C18H22Cl2N2O2
Molecular Weight
369.3  g/mol
InChI Key
ZQVZPANTCLRASL-UHFFFAOYSA-N
FDA UNII
6TGQ35Z71K

Diclofenac Diethylamine
1 2D Structure

Diclofenac Diethylamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[2-(2,6-dichloroanilino)phenyl]acetic acid;N-ethylethanamine
2.1.2 InChI
InChI=1S/C14H11Cl2NO2.C4H11N/c15-10-5-3-6-11(16)14(10)17-12-7-2-1-4-9(12)8-13(18)19;1-3-5-4-2/h1-7,17H,8H2,(H,18,19);5H,3-4H2,1-2H3
2.1.3 InChI Key
ZQVZPANTCLRASL-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCNCC.C1=CC=C(C(=C1)CC(=O)O)NC2=C(C=CC=C2Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
6TGQ35Z71K
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 78213-16-8

2. Diclofenac (diethylamine)

3. Diclofenac Diethylammonium Salt

4. 6tgq35z71k

5. 2-[2-(2,6-dichloroanilino)phenyl]acetic Acid;n-ethylethanamine

6. Voltarol

7. Mfcd01862249

8. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Compd. With N-ethylethanamine (1:1)

9. Diclofenac Diethylammonium

10. Diclofenac Diethylamine Salt

11. Unii-6tgq35z71k

12. Voltaren Emulgel (tn)

13. N-ethylethanaminium{2-[(2,6-dichlorophenyl)amino]phenyl}acetate

14. Diethylammonium Diclofenac

15. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid, Compd. With N-ethylethanamine

16. Schembl1116300

17. Dtxsid40999449

18. 4-bromo-4-methoxybiphenyl

19. Hms3651l18

20. Hms3885e07

21. Bcp24521

22. Hy-15036a

23. S3063

24. Akos015907253

25. Ccg-268279

26. Diclofenac Diethylamine [mart.]

27. Ks-5039

28. Diclofenac Diethylamine [who-dd]

29. Sy110689

30. Db-056293

31. Diclofenac Diethylammonium Salt [mi]

32. Ft-0603077

33. Sw219367-1

34. D07817

35. H10150

36. 213d168

37. A923342

38. Diclofenac Diethylamine (diethylammonium Diclofenac)

39. Q27265501

40. Diethylamine 2-(2-(2,6-dichlorophenylamino)phenyl)acetate

41. [2-(2,6-dichloroanilino)phenyl]acetic Acid--n-ethylethanamine (1/1)

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 369.3 g/mol
Molecular Formula C18H22Cl2N2O2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count6
Exact Mass368.1058333 g/mol
Monoisotopic Mass368.1058333 g/mol
Topological Polar Surface Area61.4 Ų
Heavy Atom Count24
Formal Charge0
Complexity315
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

EU WC

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Virtual BoothTranso-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Diclofenac Diethylamine

Date of Issue : 2022-02-22

Valid Till : 2025-07-15

Written Confirmation Number : TFDA-0002291

Address of the Firm : No. 168, Kai Yuan Rd, Hsin-Ying, Tainan City 73055, Taiwan

Transo Pharm Handels GmbH

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Diclofenac Diethylamine BP/IP

Date of Issue : 2025-08-26

Valid Till : 2028-08-25

Written Confirmation Number : WC-0134

Address of the Firm : (A Division of Umedica Laboratories Pvt. Ltd.)Plot no. 322/4, 40 Shed Area, G.I....

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Hetero Drugs

India
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Hetero Drugs

India
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Diclofenac Diethylamine IH

Date of Issue : 2022-09-30

Valid Till : 2025-08-08

Written Confirmation Number : WC-0066

Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...

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Diclofenac Diethlamine BP

Date of Issue : 2025-08-26

Valid Till : 2028-08-25

Written Confirmation Number : WC-0076

Address of the Firm : Plot No.5, Phase-IV, G.I.D.C, Industrial Area, Panoli-394116, Dist-Bharuch, Guja...

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KDMF

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Diclofenac diethylammonium

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2011-05-31

Registration Number : 20110531-80-D-96-09

Manufacturer Name : Amoli Organics (A division o...

Manufacturer Address : Plot No. 322/4, 40 Shed Area, GIDC Vapi-396 195, Gujarat State, India

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Diclofenac diethylammonium

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2013-01-10

Registration Number : 20110531-80-D-96-09(2)

Manufacturer Name : Amoli Organics (A Division o...

Manufacturer Address : Plot No. 322/4, 40 Shed Area, GIDC, Vapi-396195 Gujarat State, India

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Diclofenac diethylamine

Registrant Name : Sanil Pharma Co., Ltd.

Registration Date : 2021-07-08

Registration Number : 20110531-80-D-96-09(3)

Manufacturer Name : Amoli Organics Pvt. Ltd

Manufacturer Address : Plot No. 322/4, 40 Shed Area, GIDC, Vapi-396195, Gujarat State, India

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Diclofenac diethylammonium

Registrant Name : Heilion Korea Co., Ltd.

Registration Date : 2025-02-05

Registration Number : 20250205-80-D-164-24

Manufacturer Name : Henan Dongtai Pharm Co., Ltd...

Manufacturer Address : No.2, East Kangtai Road, Tangyin County, Anyang City, Henan Province, PR China

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Diclofenac diethylammonium

Registrant Name : Heilion Korea Co., Ltd.

Registration Date : 2019-01-21

Registration Number : 20190121-80-D-154-12

Manufacturer Name : Unique Chemicals (A Division...

Manufacturer Address : Plot No. 5, Phase IV, GIDC Industrial area, City: Panoli-394 116, Dist: Bharuch, Guja...

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Diclofenac diethylamine salt

Registrant Name : Heilion Korea Co., Ltd.

Registration Date : 2011-03-31

Registration Number : 20110331-80-D-95-07

Manufacturer Name : [Partial contract manufactur...

Manufacturer Address : [Partial contract manufacturing (manufacturer)] (synthesis) Pyewipe, Grimsby, NE Linc...

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Olon S.p.A

Italy
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Italy
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Diclofenac diethylammonium

Registrant Name : Heilion Korea Co., Ltd.

Registration Date : 2019-09-18

Registration Number : 20190918-80-D-155-21

Manufacturer Name : OLON SpA@[Intermediate Zodic...

Manufacturer Address : Via Benvenuto Cellini, 20, 20054 Segrate, Milano, Italy@[Intermediate Zodiclofenac So...

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Polaris AI Pharma

South Korea
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South Korea
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Diclofenac beta-dimethylaminoethanol

Registrant Name : Polaris AI Pharma Co., Ltd.

Registration Date : 2011-03-31

Registration Number : 20110331-80-D-105-08

Manufacturer Name : S-Tech Pharma Co., Ltd.

Manufacturer Address : (445-938) 25 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

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Redox Bio

South Korea
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Redox Bio

South Korea
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Diclofenac beta-dimethylaminoethanol

Registrant Name : Redox Bio Co., Ltd.

Registration Date : 2012-06-20

Registration Number : 20120620-80-D-113-15

Manufacturer Name : Redox Bio Co., Ltd.

Manufacturer Address : 83, Yakjakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do (Diclofenac Sodium Ma...

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SamoFarm

Uzbekistan
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SamoFarm

Uzbekistan
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Diclofenac beta-dimethylaminoethanol

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2012-03-23

Registration Number : 20120323-80-D-111-14

Manufacturer Name : Samoh Pharmaceutical Co., Lt...

Manufacturer Address : (429-852) Samoh Pharmaceutical, 63 Okgucheonseo-ro 81beon-gil, Siheung-si, Gyeonggi-d...

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NDC API

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DICLOFENAC DIETHYLAMINE

NDC Package Code : 62512-0011

Start Marketing Date : 2018-01-01

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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DICLOFENAC DIETHYLAMINE

NDC Package Code : 48589-0003

Start Marketing Date : 2009-09-28

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Olon S.p.A.

Italy
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Olon S.p.A.

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DICLOFENAC DIETHYLAMINE

NDC Package Code : 17337-0407

Start Marketing Date : 2017-12-12

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Diclofenac Diethylamine

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Diclofenac Diethylamine

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
Tenatra

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Diclofenac Diethylammonium

About the Company : Biesterfeld Spezialchemie GmbH is a part of the Biesterfeld Group. Biesterfeld Spezialchemie GmbH is a pan-European, rapidly growing distributor of products requiring special perfo...

Biesterfeld Spezialchemie GmbH is a part of the Biesterfeld Group. Biesterfeld Spezialchemie GmbH is a pan-European, rapidly growing distributor of products requiring special performance in the fields of LifeScience, Nutrition, CASE (Coatings, Adhesives, Sealants, Elastomers) & Performance Products. In cooperation with leading companies in the chemical industry, our sales team - with its focus on technical applications - is constantly working on innovative products for the international market.
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Globalpharma

U.A.E
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Diclofenac Diethylamine

About the Company : Globalpharma is a wholly owned subsidiary of Dubai Investments PJSC. Established in 1998, Globalpharma is currently a market leader in key generic pharma segments with a strong reg...

Globalpharma is a wholly owned subsidiary of Dubai Investments PJSC. Established in 1998, Globalpharma is currently a market leader in key generic pharma segments with a strong regional footprint. Globalpharma started its operations in the UAE in 2003 and expanded its growth in 2008 with product line extensions and New product launches across 14 countries in the GCC and select African markets. Currently Globalpharma has two Manufacturing plants, A state of the art Beta-Lactam Penicillin Manufacturing plant providing the Amoxicillin & AmoxiClav brands in the larger MENA region.
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Diclofenac Diethylamine

About the Company : Established in 1976, J.B.Chemicals & Pharmaceuticals Ltd. (JBCPL) is one of India’s fastest growing pharmaceutical companies. An integrated, research-oriented, public listed orga...

Established in 1976, J.B.Chemicals & Pharmaceuticals Ltd. (JBCPL) is one of India’s fastest growing pharmaceutical companies. An integrated, research-oriented, public listed organisation with a focus on supplying affordable, quality products both in India and International markets, JBCPL is trusted by healthcare professionals globally. Today, JBCPL exports to over 30 countries across the world and earns more than half its revenue from its international business. JBCPL is widely committed to manufacturing a range of innovative specialty products that include various pharmaceutical dosage forms like tablets, injectable (vials, ampoules.
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JRC

India
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JRC

India
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Diclofenac Diethylamine

About the Company : We commit to be a customer focused business and acknowledge that to be successful we have to make the opportunity offered by our clients work for them and for the future prosperity...

We commit to be a customer focused business and acknowledge that to be successful we have to make the opportunity offered by our clients work for them and for the future prosperity of JRC. The opportunity within JRC is to promote an open environment to explore knowledge, share thoughts in a transparent manner and maintain our commitments to all the stakeholders at large. JRC’s strength over 5 years is in science and technology that includes synthetic organic chemistry, process research, and scale-up from laboratory to commercial-scale along with quality and regulatory support.
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Diclofenac Diethylamine

About the Company : Nortec Química stands as the largest manufacturer of Active Pharmaceutical Ingredients (IFAs) in Latin America, embarking on its mission to ensure the availability of quality medi...

Nortec Química stands as the largest manufacturer of Active Pharmaceutical Ingredients (IFAs) in Latin America, embarking on its mission to ensure the availability of quality medicines with IFAs developed in Brazil. The company's approach involves leveraging the expertise of major National Research Centers and tapping into the experience of the Brazilian Chemical and Petrochemical Industry. Nortec Química plays a significant role in the Brazilian pharmaceutical landscape and the Unified Health System (SUS), producing APIs for branded, generic, and similar medicines, as well as medicines dedicated to addressing neglected diseases.
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Olon S.p.A

Italy
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Italy
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Diclofenac Diethylamine

About the Company : We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (...

We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for generic and contract development and the manufacturing market, in a full cGMPs environment, following ICH Q7 compliance.
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Diclofenac diethylamine

About the Company : SNEHA MEDICARE PVT LTD., one of the pioneers in API sourcing and supply in India, was established in 1985 by Shri. Kirti M Shah in the name of SNEHA CHEMICALS, which was later chan...

SNEHA MEDICARE PVT LTD., one of the pioneers in API sourcing and supply in India, was established in 1985 by Shri. Kirti M Shah in the name of SNEHA CHEMICALS, which was later changed to M/s SNEHA MEDICARE PVT LTD. in the year 2002. sneha medicare is an established brand its import and exports. We thrive to provide our customers with the highest quality material, and have established ourselves among the most eminent and trustworthy supplier of High Grade APIs and formulations.
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Diclofenac Diethylamine

About the Company : Srikem is a trusted source of Active Pharmaceutical Ingredients (APIs) for top pharmaceutical companies around the world. The company was founded in the year 1994 and our founder M...

Srikem is a trusted source of Active Pharmaceutical Ingredients (APIs) for top pharmaceutical companies around the world. The company was founded in the year 1994 and our founder Mr. Srinivasan has over 42 years of experience in this industry. We are an approved vendor for the top 10 pharmaceutical companies in India. Our plant is a multi-purpose unit handling operations involved in organic synthesis, which meets the standards prescribed by various agencies like FDA, Pollution Control Board, Health and Safety Authorities. We have a global presence in over 40 countries.
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API Reference Price

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06-Jan-2022
28-Aug-2025
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Drugs in Development

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  • Development Update

Details:

Diclofenac Diethylamine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Musculoskeletal Injuries.


Lead Product(s): Diclofenac Diethylamine,Ibuprofen

Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Hamilton Health Sciences

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 28, 2025

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01

University of Calgary

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University of Calgary

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Details : Diclofenac Diethylamine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Musculoskeletal Injuries.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 28, 2025

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Details:

Diclofenac Diethylammonium is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.


Lead Product(s): Diclofenac Diethylamine,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 01, 2025

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02

Haleon

United Kingdom
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Haleon

United Kingdom
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Details : Diclofenac Diethylammonium is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 01, 2025

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Europe

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2Care4 Aps

Denmark
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2Care4 Aps

Denmark
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Diclofenac Diethylamine

Brand Name : Voltaren

Dosage Form : Gel

Dosage Strength : 23.2mg/g

Packaging :

Approval Date : 16/08/2022

Application Number : 20220318000033

Regulatory Info : Deregistered

Registration Country : Sweden

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Diclofenac Diethylamine

Brand Name : Diclofenac Apofree

Dosage Form : Gel

Dosage Strength : 23.2mg/g

Packaging :

Approval Date : 25/09/2017

Application Number : 20161102000085

Regulatory Info : Approved

Registration Country : Sweden

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Diclofenac Diethylamine

Brand Name : Diclofenac Net

Dosage Form : Gel

Dosage Strength : 23.2mg/g

Packaging :

Approval Date : 25/09/2017

Application Number : 20161102000092

Regulatory Info : Approved

Registration Country : Sweden

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Diclofenac Diethylamine

Brand Name : Voltadol

Dosage Form : Gel

Dosage Strength : 11.6MG

Packaging :

Approval Date : 2017-05-05

Application Number : 1-23820

Regulatory Info : Authorized

Registration Country : Spain

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Haleon Spain Sa

United Kingdom
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Haleon Spain Sa

United Kingdom
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Diclofenac Diethylamine

Brand Name : Voltadol Strong

Dosage Form : Gel

Dosage Strength : 23.2MG

Packaging :

Approval Date : 2014-01-27

Application Number : 78407

Regulatory Info : Authorized

Registration Country : Spain

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Diclofenac Diethylamine

Brand Name : Diclofenaco Kern Pharma

Dosage Form : Gel

Dosage Strength : 11.6MG

Packaging :

Approval Date : 2011-05-25

Application Number : 74119

Regulatory Info : Authorized

Registration Country : Spain

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Diclofenac Diethylamine

Brand Name : Voltaren Emulgel

Dosage Form : Gel

Dosage Strength : 11.6MG

Packaging :

Approval Date : 1989-10-01

Application Number : 58402

Regulatory Info : Authorized

Registration Country : Spain

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Diclofenac Diethylamine

Brand Name : Diclofenac Orifarm

Dosage Form : Gel

Dosage Strength : 11.6mg/g

Packaging :

Approval Date : 16/09/2011

Application Number : 20101204000057

Regulatory Info : Deregistered

Registration Country : Sweden

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Diclofenac Diethylamine

Brand Name : Diclofenac Stada

Dosage Form : Gel

Dosage Strength : 23.2mg/g

Packaging :

Approval Date : 23/12/2019

Application Number : 20190128000052

Regulatory Info : Approved

Registration Country : Sweden

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Teva Bv

Israel
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Teva Bv

Israel
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Diclofenac Diethylamine

Brand Name : Diclofenac Teva

Dosage Form : Gel

Dosage Strength : 23.2mg/g

Packaging :

Approval Date : 10/02/2022

Application Number : 20200529000022

Regulatory Info : Approved

Registration Country : Sweden

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ABOUT THIS PAGE

Looking for 78213-16-8 / Diclofenac Diethylamine API manufacturers, exporters & distributors?

Diclofenac Diethylamine manufacturers, exporters & distributors 1

99

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

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

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

API | Excipient name

Diclofenac Diethylamine

Synonyms

78213-16-8, Diclofenac (diethylamine), Diclofenac diethylammonium salt, 6tgq35z71k, 2-[2-(2,6-dichloroanilino)phenyl]acetic acid;n-ethylethanamine, Voltarol

Cas Number

78213-16-8

Unique Ingredient Identifier (UNII)

6TGQ35Z71K

Diclofenac Diethylamine Manufacturers

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

Diclofenac Diethylamine Suppliers

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

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

Diclofenac Diethylamine KDMF

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

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

After submitting a Diclofenac Diethylamine 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 Diclofenac Diethylamine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Diclofenac Diethylamine suppliers with KDMF on PharmaCompass.

Diclofenac Diethylamine WC

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

click here to find a list of Diclofenac Diethylamine suppliers with Written Confirmation (WC) on PharmaCompass.

Diclofenac Diethylamine 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 Diclofenac Diethylamine as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Diclofenac Diethylamine suppliers with NDC on PharmaCompass.

Diclofenac Diethylamine GMP

Diclofenac Diethylamine 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 Diclofenac Diethylamine 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 Diclofenac Diethylamine GMP manufacturer or Diclofenac Diethylamine GMP API supplier for your needs.

Diclofenac Diethylamine CoA

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

Diclofenac Diethylamine CoA mostly includes findings from lab analyses of a specific batch. For each Diclofenac Diethylamine 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.

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