Certifications:

WHO-GMP & EU-GMP

All systems are governed by Quality Managemnt systems (QMS) with strict adherence to laid down procedures and systems

General Injectable Unit.

Capacity:

1. Ampoules: 300 Ampoules/Minute
2. Liquid Vials: 250 Vials/ Minute
3. Lyophiliser: 2 x 54,000 of 10 ML/ Lot
4. DPI: 300 Vials/ Minute

General Tablet, Capsule & Sachet Unit.

Capacity:

1. Granulation: 3 Suits of 300 KGS, 150 KGS and 60 KGS respectively and tablets compression to compliment the same.
2. Capsules: 90,000 Caps/Hour.

All Manufacturing activities are digitalized with PLC/HMI/SCADA system, confirming to 21 CFR standards .

Key Features of Quality control in the Manufacutring block at Baska

Well equipped Quality Control lab with all relevant sections

1. Chemical Analysis
2. Instrumental Analysis with all advanced instrumentation like HPLCs, GCs, IR, UV, Voltameter, ICP-OES, Zetasizer etc.
3. Microbiological Analysis where apart from regular testing methodology BDR is also equipped with rapid sterility testing equipment that can reduce sterility testing time to 6 hours
4. Separate section for verification of physical parameters of the manufactured dosage form
5. Packaging material Analysis also carried out
6. Stability study section having various conditions to cater the stability protocols prevailing across various global zones

Key Features: R & D Centre at Baska, Gujarat

1. Area: 5,000 Sq/mtr.
2. ADL, Micro, RQO, Stability: 1350 Sq/mtr.
3. FRD General Category: 1400 Sq/mtr.
4. F&D Onco Area: 170 Sq/mtr.
5. 13 Euro vent certified AHU.
6. Current Scientist Strength: 180++.
7. Capable to undertake development of complex formulations such as Microsphere, Liposomal, Nanoparticle, Lyophilised, Sustained Released, Extended Release, IR- Solid/Liquid (tablets (sublingual/chewable/ODR) , semi-solid and topical dosage forms.

Plant Location

Plant 1: RS No 578, Near Effluent Canal, Luna, Padra, Vadodara

Plant 2: Survey No. – 51/1/1, 51/1/2…52/5,53/1,53/2..54/2, At – Vanseti Village, Po – Tajpura, Taluka-Halol, Dist. Panchmahal – 389 350, Gujarat

Formulation Facilities of BDR Group

1. Oncology Oral Solid Dosage Unit based in Padra, Gujarat.
2. General Injectable Unit based in Halol, Gujarat.
3. General Tablet, Capsule and Sachet Unit based in Halol, Gujarat.
4. Oncology Injectable Unit (Up-Coming) based in Halol, Gujarat.

Regulatory Approvals

1. EU-GMP
2. WHO-GMP
3. Anvisa
4. Kenya-PPB
5. Belarus GMP
6. Nigeria - NAFDAC
7. PIC's Philippines
8. Ukraine
9. Malaysia
10. Invima
11. Thailand - FDA
12. Uganda - NDA
13. Sudan - NMPB
14. Yemen - SBDMA

Features

1. Dedicated “stand alone” block for Oncology.
2. Each stage of operation in dedicated areas with individual AHUs to minimize cross contamination.
3. Dedicated capacities for Coated/Uncoated tablets and capsules in Blisters.
4. Oncology range of products are handled under “Isolators” and with special protective gowns for operators to minimize risk of exposure.
5. Triple-layer security: Product vs. Human exposure.
6. Best-in-class quality compliance demonstrated by negligible rejection rate.

Plant Location

BDR Oncology & General API, RS No.-578, Near Effluent Channel, Luna, Padra, Vadodara.

Regulatory Approvals of API Plants

1. Both Oncology API & General API blocks have WHO GMP certification
2. ANVISA Approved
3. Both the Blocks have scheduled inspection by EMEA in the near future

Capacities of API Blocks

1. General 15.75 KL/day
2. Oncology Plant 1 4.75 KL/day
3. Oncology Plant 2 75 KL/day

Features

1. Individual Blocks on “stand alone” basis for Oncology and general products
   1. 9 reactors in General API section
   2. 4 reaction in Oncology API section of Plant 1
2. Each stage of operation in dedicated areas with individual AHUs to minimize cross contamination
3. Oncology range of products are handled under “Isolators” and with special protective gowns for operators to minimize risk of exposure
4. Includes 2,800 m2 of area dedicated to admin, utilities and warehouse utilized by OSD as well as API facilities
5. Exhausts from the manufacturing blocks through scrubber system to control environmental pollution
6. High capacity "Treatment Plant" for treating effluents
7. Special solvent recovery plant gives an additional advantage in API processing
8. Equipped with separate Gram-scale manufacturing areas that handles processing of high potency molecules

Reaction Capabilities

1. Reduction
2. Nitration
3. Acetylation
4. Hydrolysis
5. Grignard
6. Chlorination
7. Bromination
8. Hydrogenation

Plant Location

Block No. 46-47, Plot No. 02, Moje Taluka: Palsana, Guajarat 394315.

Regulatory/Plant Approval

1. WHO GMP certification

Plant Capacity

1. Current 110 KL
2. Post Expansion180 KL

Products Patents

1. US Patent for Etoricoxib No. US 8,841,457 B2
2. Filed Indian and PCT applications for Linezolid

Features

1. Fraction Column for Solvent Recovery: Installation of 2 packed columns with 5KL and 4KL capacities respectively for effective separation of Binary solvent mixtures at low cost with maximum recovery to ensure product viability.
2. Gram-scale manufacturing zone : Equipped with separate Gram-scale manufacturing zone that handles processing of high potency molecules.
3. Hydrogenation Process : Installation of 2 Hydrogenation Plants with 25 kg/ CM2.
4. Tetracycline Derivative's Reactors : Addition of Cycline (Tetracycline Derivative's) Block, 30 reactors

Expertise and capability to handle following Reaction Processes:

1. Fiedal Craft Acylation/Alkylation
2. Oxidation (H2O2CR2O3 )
3. Cryogenic Reaction (Temp upto 80°C - 100°C)
4. Grignard reaction
5. Nitration
6. N-Butyl Lithium reaction
7. Sodium Metal Reaction
8. Cyanation
9. Bromination
10. Acetylation
11. Chiral Separation
12. Esterification
13. Chromatographic Separation

Plant Location

Plot No. 163/D, Phase II, Cherlapally, Kapra Municipality, Ghatkesar Mandal, R.R. District, Hyderabad - 500 051.

Regulatory Approvals

GMP Approved

Features

1. Our company with diverse product portfolio and best manufacturing facility is moving towards the global markets. We are counted among the most reputed manufacturers, exporters and suppliers of Pharmaceutical Pellets.
2. Magnum Chemi-Gran Private Limited is located in Hyderabad in India driven by the vision to provide the best possible range of international quality products at competitive prices through integration, research, innovation, technology & development.
3. Our plant is run by a professional team of skilled chemists and quality control people and our plant complies with WHO- GMP standards.
4. Our company is an integrated export oriented domestic pharmaceutical company, producing best quality branded medicines. Our Company Export Products all over the world. Our company is making its presence felt and making rapid progress in Novel Drug Delivery Systems (NDDS) Namely Sustained / Controlled / Extended / Modified / Continuous Release, Ready To Fill Pellets And Ready To Compress Granules.

Oncology Oral Solid Dosage and Injectable Unit.

Location

03 Zone industrielle Ain Yogout, Batna – Algeria - 05031

Site with production blocks and separate Admin block

Production block to handle

1. Liquid Inj Vials/Lyo Inj Vials for Onco range of products
2. OSD tabs (coated/uncoated) & caps for Onco range of products
3. Lyo capacity of 7.5 M = 15k vials of 10ml/lot
4. Granulation capacity upto 3-12kgs/lot
5. Multilayered Tabs – compression capabilities
6. Controlled storage condition as per norm
7. All operation carried out under containment system
8. Self sufficient QC lab

A herbal extract manufacturing unit along with R&D and pilot scale situated at Ramlingam Palle Village, Bommalaramaram Mandal, Yadadri Bhuvangiri District, Telangana State

Key Feature

1. To establish a Herbal Extracts Manufacturing Unit along with the R&D and pilot scale to capture the market needs
2. No process emission from the unit. Fugitive emission will be controlled by close material handling system and proper storage of materials

Area: total area covered is 4.8 acres

Annual Capacity: 54 tons/annum

Some of the major products: Amla Extract, Ashwagandha Extract, Curry leaf extract, Gokshuru Extract, Senna Leaf Extract, Tulasi Extract, Turmeric Extract