Dolestine | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Dolestine
Europe

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

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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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Coral

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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Dolestine

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 5 USDMF, 3 CEP/COS, 2 JDMF, 1 EU WC, 6 NDC API, 6 Listed Suppliers, $ API Reference Price

17 API Suppliers
5 USDMF
3 CEP/COS
2 JDMF
1 EU WC
6 NDC API
6 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers, 79 FDA Orange Book, 9 Europe, 1 Canada, 16 Listed Dossiers

105 FDF Dossiers
79 FDA Orange Book
9 Europe
1 Canada
16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/ML, INJECTABLE;INJECTION - 25MG/ML, INJECTABLE;INJECTION - 50MG/ML, INJECTABLE;INJECTION - 75MG/ML, TABLET;ORAL - 100MG, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML

INJECTABLE;INJECTION - 100MG/ML
INJECTABLE;INJECTION - 25MG/ML
INJECTABLE;INJECTION - 50MG/ML
INJECTABLE;INJECTION - 75MG/ML
TABLET;ORAL - 100MG
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 10MG/ML

DIGITAL CONTENT

2 News #PharmaBuzz

2 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 14 Regulatory FDF Prices

2 US Medicaid Prescriptions
14 Regulatory FDF Prices

MARKET PLACE

6 APIs

6 APIs

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 543 Xls

Filters

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filter Applicant Reset all filters

9 All

01 1Altan Pharmaceuticals Sa

02 1Basi Pharmaceutical Industry Laboratories Sa

03 1Kern Pharma Sl

04 1MOLTENI & C. F.LLI ALITTI SpA

05 1MONICO SpA

06 1Panpharma

07 1SALF SpA

08 2Takeda AS

filter Active Ingredients Reset all filters

9 All

01 5Meperidine Hydrochloride

02 4Pethidine Hydrochloride

filter Dosage Form Reset all filters

9 All

01 4Injectable Solution

02 1Injection fluid, resolution

03 1Insert the pill

04 3Blank

filter Country Reset all filters

9 All

01 3Italy

02 2Norway

03 4Spain

filter Brand Name Reset all filters

9 All

01 1Dolantina

02 3Pethidine Hydrochloride

03 2Petidin

04 1Petidina Basi

05 1Petidina Panpharma

06 1Petidine Hydrochloride Altan

List of Suppliers

Product Main Page

01

Altan Pharmaceuticals Sa

PREP

Not Confirmed

Altan Pharmaceuticals Sa

PREP

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Pethidine Hydrochloride

Brand Name : Petidine Hydrochloride Altan

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2010-10-13

Application Number : 72848

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Basi Pharmaceutical Industry Laboratorie...

PREP

Not Confirmed

Basi Pharmaceutical Industry Laboratorie...

PREP

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Pethidine Hydrochloride

Brand Name : Petidina Basi

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2024-03-01

Application Number : 89406

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

03

Kern Pharma Sl

Luxepack

Not Confirmed

Kern Pharma Sl

Luxepack

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Pethidine Hydrochloride

Brand Name : Dolantina

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 1955-07-01

Application Number : 24245

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

MOLTENI & C. F.LLI ALITTI SpA

PREP

Not Confirmed

MOLTENI & C. F.LLI ALITTI SpA

PREP

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Italy

Meperidine Hydrochloride

Brand Name : Pethidine Hydrochloride

Dosage Form :

Dosage Strength : 5 Ampoule 100 Mg 2 Ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Panpharma

PREP

Not Confirmed

Panpharma

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Digital Content

Regulatory Info : Cancelled

Registration Country : Spain

Pethidine Hydrochloride

Brand Name : Petidina Panpharma

Dosage Form : Injectable Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 2019-10-10

Application Number : 80314

Regulatory Info : Cancelled

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Takeda AS

PREP

Not Confirmed

Takeda AS

PREP

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Digital Content

Regulatory Info :

Registration Country : Norway

Meperidine Hydrochloride

Brand Name : Petidin

Dosage Form : Insert the pill

Dosage Strength : 100 mg

Packaging : Carton

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Takeda AS

PREP

Not Confirmed

Takeda AS

PREP

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Norway

Meperidine Hydrochloride

Brand Name : Petidin

Dosage Form : Injection fluid, resolution

Dosage Strength : 50 mg/ml

Packaging : Ampoule of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

SALF SpA

Country

Luxepack

Not Confirmed

SALF SpA

Country

Luxepack

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Country

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Regulatory Info :

Registration Country : Italy

Meperidine Hydrochloride

Brand Name : Pethidine Hydrochloride

Dosage Form :

Dosage Strength : 5 Ampoule 100 Mg 2 Ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

MONICO SpA

Country

Luxepack

Not Confirmed

MONICO SpA

Country

Luxepack

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Meperidine Hydrochloride

Brand Name : Pethidine Hydrochloride

Dosage Form :

Dosage Strength : 5 Ampoule 100 Mg 2 Ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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