AMR Pharma

AMR Pharma India Private Limited based at Tamilnadu is a leading pharmaceutical company with expertise in solid and liquid oral medicine manufacturing. Contract manufacturing and third party manufacturing are also undertaken.

LIST OF APPROVED PRODUCTS

Equipment (Medicine Manufacturing)

• All major processing, Packing and analysing equipment’s with 21 CFR compliance.
• High efficient Pam Glatt Fluid Bed processor, which is one of the world class equipment.
• Sejong Coating machine.
• Flexible stability chambers.

Facility (Medicine Manufacturing)

• Our manufacturing unit comprise of complete epoxy flooring, PU painting and fully paneled false roofing.
• The full facility is equipped with class 100,000 AHU.
• All the major process areas are equipped with separate AHUs.
• Currently we are handling 7 products ( solid orals) and 2 products ( Liquids ) at the same time.
• Separate Dispensing and sampling area to avoid cross contamination is available.
• Separate primary changing rooms and secondary changing rooms for ground and first floor (solid orals and liquid area) are also available.
• Separate storage areas for raw materials, primary, secondary & tertiary packing materials and capsules are provided by us.
• State of the art ETP system.
• Green belt eco-friendly area of more than 3 acres.
• Separate waste storage area.
• Availability of separate rejects storage areas (In process and rejected material).

Product Output (Medicine Manufacturing)

• Equipment can produce approx. 2.5 billion Units(Tablets and capsules) and 10 Million bottles(liquids) per annum.
• All area equipped with separate IPQA.
• All individual rooms can be monitored for Temp and RH.
• All utility lines are of SS304 fabrication and Purified water line fabricated with SS316L and certified for its integrity.

Manufacturing Skills:

SOLIDS (Medicine Manufacturing)

• Capsules
• Tablets (coated & uncoated)
• Effervescent tablets
• Orally Disintegrating Tablets (ODT)
• Granules.
• Tablet in Tablet

LIQUIDS (Medicine Manufacturing)

• Solutions
• Suspensions
• Syrups

Research And Development

AMR Pharma’s Research and Development department offers a miniature facility of the production department comprising the features of the capsulation, Granulation, compression, coating and Packing. Our specialized scientific team has the capability to design various kinds of oral dosage forms like Capsules, Tablets in single as well as Bi-layered form, uncoated, coated, dispersible, sustained, delayed release and sublingual formulations.

At our Research and Development Department our expert team is highly skilled and equipped to handle various formulation processes including direct compression, aqueous and non-aqueous granulation. As per the requirement and necessity of each product we transfer and develop the products in accordance to the regulatory check.

Quality Control

Our Quality Control lab is the backbone of our entire quality process wherein the exclusive chemical, instrumentation and microbiology labs are offered the facility of testing the API, Excipients, Packaging, In-process materials and finished drug products. All the processes are carried out as per the norms of the standards as prescribed by the laboratory authorities. The lab is well furnished with advanced, automated and contemporary applications. We undergo a timely audit check to ensure the quality and safety of each product.

Quality Assurance
We at AMR Pharma (Medicine Manufacturing) assure the delivery of great quality of products. We are constantly striving to implement stringent quality procedures and controls on the entire product life cycle from development to shelf life. A proper quality management system is followed to ensure that all the activities are carried out as per the written SOPs.

Stability studies are routinely performed at various time points under conditions of different temperature and humidity (Real time, Accelerated and Stress studies as per ICH guidelines). Storage conditions meet the ICH standards, including:

25°C/60%RH
30°C/65%RH
40°C/75%RH.

AMR Pharma India Private Limited
Oral Solid and Liquid Medicine Manufacturing
Y-34, 1A Bhagyalekha Apts,
5Th Avenue, Anna Nagar West
Chennai 600040.
Ph: +91-9840266134

AMR Pharma India Private Limited
Oral Solid and Liquid Medicine Manufacturing
No.83, Sengundram Village
Gokulapuram, Kancheepuram 603204
Ph: +91-8754031748

http://www.amrpharma.com/index.html

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