Glycopyrrolate / Glycopyrronium Bromide

Glycopyrrolate / Glycopyrronium Bromide
Product Description

Glycopyrrolate is manufactured at a USFDA Inspected, EUGMP Certified, Cofepris Mexico, and Korean FDA-approved facility, which is also WHO-GMP certified and compliant with major regulatory bodies worldwide. 

Our regulatory filings details are given below.
USDMF Numbers:

Glycopyrrolate - US-DMF is filed 
USDMF number is 038550.

Glycopyrrolate - CEP will be filed by the end of 2023.

Written Confirmation: Available.

Swati Spentose Pvt. Ltd.

  • Country/Region:
    India
  • Founded:
    1982
  • On CPHI since:
    2015
  • Certificates:
    3
  • Employees:
    1000 - 4999
Company types
Manufacturer/Innovator
Primary activities
API Producer
Cosmetic Ingredients
Excipients Manufacturer
Intermediates Manufacturer
Pharmaceutical Company (generic finished products)
Specifications
  • Selling Points
    International Approvals/Standards; Price; Prompt Delivery; Quality Service; Sustainability
  • Supplied from
    India

Swati Spentose Pvt. Ltd.

  • Country/Region:
    India
  • Founded:
    1982
  • On CPHI since:
    2015
  • Certificates:
    3
  • Employees:
    1000 - 4999
Company types
Manufacturer/Innovator
Primary activities
API Producer
Cosmetic Ingredients
Excipients Manufacturer
Intermediates Manufacturer
Pharmaceutical Company (generic finished products)

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Swati Spentose Pvt. Ltd. resources (2)

  • Brochure Swati Spentose Pvt Ltd Introduction

    We are Swati Spentose Pvt. Ltd. (SSPL), a pharmaceutical company, specializing in manufacturing APIs with backward integration and are also forward integrated into Finished Dosage Forms. Following is our short introduction and product list. Our product list and compliances are given below :

    · Unit 1 facility : Facility having approvals/certifications from USFDA, EUGMP, ANVISA (Brazil), WHO GMP, COFEPRIS (Mexico), and Korean MFDS. (AFM Certificate No.: AG12300239).

    · Unit 2 facility: A dedicated facility for steroids and hormones. It is PMDA (Japan) inspected and certified by ANVISA (Brazil) and WHO GMP.

    · BJPPL: WHO GMP certified and compliant with USFDA and EUGMP.

    . Unit 3 facility : This is our finished formulation facility complying with global regulatory standards which will be operational from Q4-2026. 

  • Brochure Swati Spentose Pvt Ltd CMO site

    We are pleased to introduce Swati Spentose Pvt. Ltd., a pharmaceutical company with over four decades of expertise in the development and manufacturing of specialty pharmaceutical products. As part of our strategic expansion, we are pleased to offer Contract Manufacturing (CMO) and Contract Development & Manufacturing (CDMO) services through our newly established, state-of-the-art formulation manufacturing facility.

    It has been developed in line with international regulatory standards and incorporates almost  90% automation to ensure consistent product quality, data integrity, and manufacturing efficiency.Our facility has been designed to meet the expectations of global regulated markets & our current manufacturing capabilities include:

    Tablets, Hard Gelatin Capsules, Ointments, Creams & Gels, Oral Liquids & Syrups, Sachet Filling & Sealing