Successful Approval of manufacturing and laboratory facilities by Saudi Food and Drug Authority

New site approval! We are happy to announce that our manufacturing and laboratory facilities for oral solids at AET Laboratories in Hyderabad (India) have been successfully registered by the Saudi Food and Drug Authority.

The registration is a great door opener for the full GCC region. It is an important addition to our existing European and international certifications (like the US FDA approval) and follows Tiefenbacher Group´s strategy to make our high-quality pharmaceuticals better available worldwide!

TIEFENBACHER GROUP – pioneering healthcare since 1963. Please visit us on www.tiefenbachergroup.com

100% Patient-centric

closer to the patient than ever before

First NCE approved

Always striving for better therapies

Frequent day-one launches

market entry at the earliest possible time

Regulatory Affairs (RA)

abundant practical experience: from development to maintenance

350+ tender awards in 12 month

Strong track record of successful tender proposals

150+ marketing partners on five continents

collective power to succeed

80+ countries worldwide

Global market access of generic, value added, and innovative products

15.000+ MAs obtained

FDF marketing authorizations and maintenance

Generic, value added, and innovative drugs

New generation of pharmaceuticals I Flexible technological fit

efficiency driven supply chain management

from API to finished product I Excellence beyond Manufacturing

own state-of-the-art production sites

broad range of technologies including highly potent drugs

small batch and high-volume production

flexible capacities

SPC waiver site in EU (Cyprus)

Internationally competitive manufacturing site based in the EU

up to 3 bn units p.y. production capacity

Industry-Leading in on-time delivery I Capacities and capabilities

GMP compliance including FDA

good manufacturing practices (GMP)

Product safety & quality for high-quality FDF

manufacturing of high-quality pharmaceuticals products

Own GMP-warehouse

Storage + European hub for APIs & narcotics

250+ European customers

Serving the needs of pharmaceutical industry

600+ APIs (Human + Animal)

Broad portfolio raw material

100% After Sales Service

Life cycle + maintenance

100+ audits

supplier qualification I inhouse capacity

Quality assurance (QA) + Regulatory Affairs (RA)

Global regulatory + compliance

130+ manufacturers

multiple sourcing options

100% entire pharmaceutical value chain

GDP (Good Distribution Practice) with on-time delivery

10+ Dosage forms

several types

generics

cost-efficient generic drug development

Value added and innovation medicines

New generation of pharmaceuticals

major indications and highly potent drugs

an innovative portfolio pipeline

150+ R&D Scientists

our center of excellence

180+ FDF Products

Dossiers developed /under development

quality assurance and intellectual property

legal framework & compliance

Own laboratories with FDA approved

stat-of-the-art inhouse development

180+ FDF Products

Dossiers developed /Under development

80+ countries worldwide

Medical innovations & healthcare solutions

Family owned

Pioneering healthcare since 1963

Pioneering Healthcare

Since 1963

100% entire pharmaceutical value chain

High-quality pharmaceuticals worldwide

400+ Customers

Pharmaceutical Out-Licensing and API distribution

800+ employees worldwide

curiosity, passion for healthcare, and diversity

>500million patients

Highly efficient R&D
project management

Affordable medical
devices

Legal Manufacturer
acc. to MDR