:: Stanton Pharmaceuticals Manufacturing Company ::

At Stanton Pharmaceuticals Manufacturing Company we offer the following range of services:

Contract Manufacturing of Oral Solid Dosage Forms :
→ Site variations
→ Co-development for dossier filing
→ Contract supply agreements
→ Bulk packaging and customized retail packaging

Dossier development in compliance with USA law guideline
Regulatory assistance
Quality Control back-up for :
→ Manufacturing (including in process controls)
→ Process validation
→ Stability testing
→ Microbiological testing
→ Formulation Product development
Sourcing of APIs:
→ Extensive database of molecules underdevelopment
→ Backed by generics API development
→ Professional sourcing experience
→ Backward integration to make API’s for finished dosage forms
Customer Service Department :
→ One window approach
→ Understanding of cross-cultural issues in communication
→ Dedicated resources to help in IPR, customized product requirements

Customer audits of our facility and processes to ensure compliance are encouraged and supported

Dedicated contract manufacturing operations for regulated markets.
Professional corporate set-up ensures efficient management of operations
Relevant experience: Stanton Pharmaceuticals Manufacturing Company has experience of regulatory processes ISO certification and USA law aspects.
Financially sound to support the investments required.
Layout to match the regulatory requirements as per USA-FDA, WHO and other international regulatory agencies.
Logical man and material movement to ensure unidirectional flow avoiding cress cross.
Flexibility in operations, design of various parameters ensures quick changeover between products.
Separate two lines, one for tablets and one for capsules, minimizing the risk of contamination or cross-contamination.

Key people in charge of operations are trained, qualified and approved by regulatory authorities.
Most people with experience from leading USA and multinational companies.
Sophisticated automated machines for various manufacturing operations.
Ability to enforce stringent controls on entire batch process.
Facility designed to maintain environmental conditions supporting high production efficiency & quick turnaround.