Source: https://formula-pharma.de/history/
Timestamp: 2020-08-12 07:10:21
Document Index: 665841295

Matched Legal Cases: ['§ 52', '§72', '§ 14', '§ 16', '§72', '§16', '§13', '§14', '§16', '§72']

History, Facts and Figures - Formula GmbH
In 1995, Formula GmbH was founded as a highly innovative company focussing on the development of medicinal products. Today, the development of medicinal products is a core business segment of Formula GmbH with the objectives of formulation of solid, semi-solid, liquid and injectable medicinal products. This also includes the development of lyophilizates, liposomes, infusible emulsions and sophisticated solid formulations, e.g. Multiple Unit Pellet Systems (MUPS).
In 2005, Formula GmbH was granted a manufacturing license for manufacturing clinical supplies regarding packaging, labelling, blinding, testing and release of solid, semi-solid and liquid formulations for non-sterile products. In recent years, the manufacturing license has been constantly expanded and adapted to the needs of our customers.
It also involves procurement of comparator products or clinical test products from non-EU countries. Therefore, the competent authority in Berlin has granted the wholesaler license as well as the import license for clinical supplies in accordance with § 52a and §72 AMG, respectively.
Medicinal products can be handled in the open state:
This is necessary in the case of clinical trials for special test designs. On the other hand, small batches of medicinal products for the market can be professionally packaged or blistered. For example, this may be used to circumvent the Sunset Clause rule [EU Regulation (EC) No No 726/2004, Article 14 (4), 14 (5)].
The manufacturing authorization and corresponding GMP certificate of Formula GmbH were successfully extended by the primary and secondary packaging of market goods, their quality control and market release.
Galenical development is always successful if analytical development and validation of analytical methods as well as stability testing are run in parallel. Therefore, our GMP-lab is instrumentally equipped to provide the required analytical services. This also includes the storage of medicinal products in climatic zones, as required by ICH.
In addition to our analytical service for developmental purposes, GMP-compliant analytics has been successively expanded. Starting materials, intermediate products and finished products are tested according to § 14 AMWHV in terms of conformity with the respective applicable pharmacopoeia or authorization specification.
The same also applies to medicinal products to be imported into the European Union from non-EU countries. The so-called “re-test”, withdrawal of retention sample and market release in accordance with § 16 AMWHV are core competences of our service spectrum.
– Pharmaceutical, analytical and galenical development
– Clinical supplies
– GMP service
– Import, re-test, market-release
– Applicant for EU-market authorization
Berlin (Germany), 1995 (Amtsgericht Charlottenburg, HRB 55 301)
Managing Directors and Owners:
Rudy Thoma and Dr. Christian Brätter
Turn over: ~1 Mio €
Galenical development medicinal products and nutrition supplement products- Formulation of pharmaceutical products: solid, liquid, injectable and infusible forms
– Lyophilization technology
Analytical development and validation of analytical methods (CPMP)- Development and validation of HPLC methods
– Development and validation of GC methods
– Development and validation of titrimetric methods
Stability testing and in-use stability (CPMP/ICH and on-going under GMP)- Climatic storage of API, clinical supplies and medicinal products in
climatic chambers: 25°C, 60% RH, 30°C, 65% RH, 40°C, 75% RH, 2 -8°C
and storage at custom specified conditions
– Analytical testing after withdrawal from stability storage
Purification, isolation and identification of degradation products in
medicinal products and drug substances
Screening of packaging materials
GMP-Quality control of starting material, packaging material,
intermediate, bulk and finished products (QC-confirmation of medicinal products in accordance with 14 AMWHV)
Import (§72 AMG), re-test and release of medicinal products from non-EU countries (§16 AMWHV))
GMP-service and audit by Qualified Person of pharmaceutical manufacturers (API/issuing of QP declaration and medicinal products)
Manufacturing of clinical supplies in accordance with §13 AMWHV
– Procurement of comparator products, e.g. originatorBlister packaging of solid formulations, dispensing of liquids and semi-solids for oral or topical application
– Analytical testing and on-going stability testing of clinical supplies in accordance with §14 AMWHV
– Recording of dissolution-data and biowaver-examinations based on the EMA-Bioequivalence Guideline
– Release for clinical studies in accordance with §16 AMWHV
– Global shipment and distribution of clinical supplies to corresponding CRO, respectively
– EU-Import of clinical supplies and formulations in bulk from non-EU countries (§72 AMG)
Applicant of market authorization inside the European Union as SME-granted company
– Support and consulting regarding regulatory affairs inside the EU and
quality check of the registration document (CTD)
– Support and service regarding Pharmacovigilance,
e.g. Site Mster File for Pharmacovigilance (SMPV),
Risk Management Plan (RMP),
Qualified Person for Pharmacovigilance (QPPV), etc.
Approach to Formula GmbH
Goerzallee 305 b, 14167 Berlin , Deutschland
+49 - (0)30 - 75 11 054
+49 - (0)30 - 757 02 408
info@formula-pharma.de
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