MANUFACTURING & FACILITIES

At Seatrack International Pharmaceutical,

Our MISSION is to provide Quality pharmaceuticals which could reach the society far and wide both in the Domestic and International markets.

Our VISION is to provide affordable healthcare to one and all. The endeavor is to be a focused and one of the largest Finished pharmaceutical injectable technology and R&D based manufacturer.

We Manufacture Finished Pharmaceutical Formulations
in the Following Categories & Forms;

. Injectable – Lyophilized – Powder – Liquid & PFS

. Capsules (General, Hormones, Oncology)

. Sterile Eye Ointments & General Creams

. Tablets (Beta Lactams, Non Beta Lactams, Hormones, Oncology)

. Sachets

. Dry Syrup/ . Liquid Syrups

. Powders

. Neutraceutical

. Eye/Ear/Nasal Drops

. Lotions

. Over the counter (OTC)

. Veterinary

RESEARCH CENTER

Research and development is an important aspect of our business strategies that provides long term competitive advantage. Dedicated terms of highly qualified scientists and professionals are engaged in the path breaking research thus generating IPR wealth. Research areas include Novel Drug Delivery Systems. Development of clinically relevant and safe Fixed Dose Combinations, Analytical Method Development. Stability Studies. Pharmacology, Toxicology, Microbiology and Natural Product Research.

A team of Regulatory Professionals are involved in dossier preparations for Regulated and Semi Regulated markets. We are in collaboration with various Government and Semi Government Research Institutes for various R& D projects.

Research & Development Facilities

FACILITY1

. A recently acquired pharmaceutical unit to manufacture a vast variety of tablets and capsules including beta lactams. The facility has high speed machines and is also equipped with technology to blister in aluminium-aluminium foils for longer stability and elegant presentation.

FACILITY2

. A state-of-art ultra-modern injectable finished pharmaceutical manufacturing having in place the latest automatic tunnel system, lyophilization to make sterile injectables and pre-filled syringes. Automatic fill-form and seal facility has also been added as part of our manufacturing facility. Heating Ventilation Air Conditioning (HVAC) and cold room chains are in place; including hygiene standards suitable to manufacture sterile products and their storage.

We solicit international enquires for “Licensing-Out” of pharmaceutical injectable formulations providing complete technology coupled with facilitation of pilot batch manufacturing.

FACILITY3

. It is specially designed and equipped for manufacturing of high quality liquid syrups, dry syrups and redi-mix syrups that are used as expectorants, antacids, anti-diarrhoeal, antibiotics, tonics and vitamin supplements. These syrups are highly effective and safe to us.

QUALITY CONTROL

In-house Quality Control Laboratories. Analytical research laboratories, Microbiology and Pharmacology laboratories are fully equipped with Sophisticated instruments like High Performance Liquid Chromatography System, Gas Chromatography System, Ultraviolet Spectrophotometer, Infra-red Spectrophotometer and all the required after Laboratory instruments.

Each product is tested for safety, quality & efficacy by team of well qualified personnel in place. Stringent and high quality standards are followed to ensure quality at each an every step of manufacturing.

The Experts in Lyophilization (Cake Form Parenteral)

In solution, many drug substances are susceptible to even modest changes in temperature and chemical environment. These complex molecules undergo hydrolytic, oxidative and aggregation reactions, compromising both potency and safety. Consequently, parenterals must often be distributed cold chained refrigerated or maintained frozen from manufacturing line to patient. Even then, freezing and/or thawing may cause some proteins to aggregate. Lyophilization overcomes poor stability by rending labile drugs and proteins in a solid form more tolerant of long term product storage.

Lyophilisation extends the shelf life of drugs and biological, preserving their chemical and biological properties. It involves less cumbersome storage and handling. Lyophilization reduces the temperature requirement for shipping and protects the biological vitality. Compared with other methods, lyophilisation dries biological at a lower temperature, reducing the damage to the product and retaining the molecular integrity.

. 9.5 Sq. Mtr Lyphilizer with capacity of 50000 vials in single batch

. 1.5 Sq. Mtr lyophillizer with capacity of 5000 vials in one cycle

. validated and standardized cycles as per product Eutectric temperatures

. fully automatic process control

. Hydraulic stopping device

. Clean In Place (CIP) cleaning system

. Steam In Place (SIP)

. steam sterilization system ( D version)

. vaporized Hydrogen Peroxide (VHP) sterilization system

. batch loader/un-loader for bulk products in trays

. loader/un-loader for products in vials without trays

.systems applying isolator and containment technology

. products and documentation to meet FDA regulations and in compliance with GLP, GMP, GAMP guidances.

Advantages of Lyophilization;

. product is stored in dry

. product is dried without elevated temperatures

. it is good for oxygen and air sensitive drugs

. rapid reconstitution

. constituents of dried drugs are homogeneously dispersed

. sterility of the product can be achieved and maintained

Advantages of Lyophilization

We have extensive experience in sterile contract manufacturing with a wealth of lyophilization expertise. In particular, the optimization of the freeze drying process as it relates to cycle times represents a critical attribute for complex parenteral product development.

Our experts support customers’ product development to achieve product stability and improved shelf-life of products destined for clinical or commercial applications. Our fill-finish service for Sterile Powder Lyophilized Vials offers individual filling, suites with lyophilization capacity, along with an intrinsically safe process that enables the use of non-aqueous solvents.

Our facilities for Sterile Lyophilization Filling where separate and dedicated filling lines exist to handle non-potent compounds.

Manufacturing;

>> Aseptic Filling using Nest & Tub technology & Materials

>> Batch Sizes range from 1 – 50 L

>> Vials from 2 R – 10 R

>> Lyophilizer (1 sqm) with Capacity Range of up to 4,000 vials (2 R) – 1,000 vials (10 R) per cycle.

>> Aseptic Fill & Finish plant hosting 2 different lines for Pre-Filled Syringes and Vials respectively. The Vial line can manage Liquid Formulation or Lyophilized Formulation, where the filling line is connected to a 5 sqm Lyophilizer able to handle up to 20,000 vials (2R) or 8,000 vials (10R) per freeze-drying cycle respectively.

Sterile Liquids

Based on our experience in manufacturing Parenteral Sterile Solutions and Emulsions in different pharmaceutical forms such as ampules, vials and pre-filled syringes. Our facility and equipment design, combined with experienced and trained personnel, is pivotal for success in sterile manufacturing.

at our plant we have main areas of production with a focus on Non-Potent traditional Small Molecules, through its long-standing expertise in Terminal Sterilization, and Aseptic Fill & Finish, through special expertise in the handling of large molecules such as Peptides, Oligonucleotides, Carbohydrates and Biologic.

Terminal Sterilization & Filling

>> 3 Separate Process Rooms Equipped with APV High-pressure Homogenizers & Solution Vessels, with batch sizes ranging from 200 L to 1250 L

>> 5 Filling Lines (3 for Vials, 1 for Ampoules, 1 for Pre-filled Syringes (PFS) /Cartridge – custom)

>> 5 Autoclaves (rotating)

>> Container Range 10 – 100 ml (option 5 ml and 150 ml )

>> Inspection

>> Automatic Inspection Machines for 20 ml & Pre-filled Syringes (PFS)

>> Semi-Automatic Inspection Machines for any other vials (50 ml & 100 ml)

Aseptic Fill & Finish

The Commercial Aseptic Fill & Finish plant hosting 2 different lines (segregated one from the other) for Pre-Filled Syringes and Vials respectively. Our manufacturing process is highly sophisticated and includes automatic inspection, packaging and serialization.

>> Aseptic Filling using Nest & Tub Technology & Materials

>> Batch Size range from 1 to 50 L

>> Vials from 2 to 10 R and PFS from 1 ml (Std or LONG) to 10 ml