FDF / DRUG PRODUCTS SERVICES in APAC
Block A, established in 1999, houses production lines for a diverse array of sterile products including Ophthalmic Drops, Pre-filled Syringes, Sterile Eye...
About the plant
Swiss Parenterals Limited is a third-generation family business with a deep history in the sterile injectables industry.
Founded in 1986 as a trading house, the company transitioned into a full-fledged manufacturing enterprise in 1999. This pivotal
moment solidified our commitment to providing high-quality sterile pharmaceutical products.
Today, as a leading provider of sterile pharmaceutical manufacturing services, we operate a state-of-the-art facility in Ahmedabad,
India, strategically positioned for global reach. Our dedication lies in delivering high-quality, safe, and effective sterile products that
meet the stringent requirements of our clients.
Our site encompasses three distinct manufacturing blocks, dedicated to producing a range of small-volume parenteral:
Block A, established in 1999, houses production lines for a diverse array of sterile products including Ophthalmic Drops, Pre-filled
Syringes, Sterile Eye Ointments, Ampoules, and Inhaled Anesthesia.
Block B, constructed in 2019, features lines for Liquid Vials and Lyophilization, Liquid Ampoules, and Sterile Dry Powder filling.
Block C, also built in 2019, serves as the hub for our Quality Assurance, Quality Control, and Administration departments.
1 Block A
Inhaled Anesthesia, Ophthalmic
Drops, Pre-filled Syringes and
Sterile Eye Ointments, Ampoules
2 Block B
Liquid Vials + Lyophilization, Liquid
Ampoules, and Sterile Dry Powder
filling
3 Block C
Quality Assurance, Quality Control,
and Administration departments
Short description of the site and blocks:
Block A:
This block manufactures inhaled anesthesia, eye drops, eye ointment, and liquid ampoules.
The ground floor houses the eye drop line, pre-filled syringe (PFS) line, liquid ampoule line, manufacturing area, day store raw
material (RM) store, and packing area.
The first-floor houses liquid inhalation (anesthesia), sterile ointment, and service areas such as the water system.
Block B:
The ground floor includes the dry powder line, liquid ampoule line, liquid vials with lyophilizers, packing line, entry airlocks for the
sterile area, manufacturing area, and autoclave area.
The first floor houses the raw material (RM) store, vials/ampoules store, finished goods (FG) store, water system, PSG, MEDS,
compressed air, and nitrogen generation plant.
The second floor includes bung stores, flip-off seal stores, sterile water for injection and diluents store, secondary packaging material
store, and printed label store. Finished goods area and reject room.
Block C:
This block contains the Quality Control Labs, Quality Assurance Office, and support teams for purchase and administration. The
building is designed for optimal functionality and includes three floors, each dedicated to specific functions.
Ground Floor: The ground floor contains the Director´s Cabin, the Quality Assurance team, the Purchase and Admin team.
First Floor: The first floor contains the Quality Control labs, which are divided into chemical and microbiology sections.
Second Floor: The second floor contains the stability chambers, where samples are stored under controlled conditions to assess their
long-term stability. It also includes an area for retaining samples for future reference and document storage for recordkeeping
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- World Health Organization (GMP / HACCP)
- NMPA (China GMP)
- TGA (Australia GMP)
- ANVISA (Brazil B-GMP)
- Roszdravnadzor (Russia GMP)
- PMDA/MHLW (Japan GMP)
- INVIMA
- COFEPRIS
- DIGEMID
- MHRA (UK GMP)
- SQF (Safe Quality Food)
- IFS
- BRCGS
Activity
- Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
- DEA: Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
- BSL:
- Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EMA (EU), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), EDE (UAE), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Genetic analysis & Pharmacogenetics, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission
