If you are looking for an API partner, you must consider their API compliance. The regulatory compliance of your drugs and raw materials is essential for patient safety and for market entry.
Chemox Pharma has been a trusted API manufacturer with strict pharma compliance in India. In this post, we will discuss how we ensure API compliance that makes clients from 20+ countries trust us. From the quality of our raw material to stability testing, we follow global standards to develop compliant, safe, and high-quality APIs.
Why Is API Compliance Important?
Before jumping into how we maintain compliance, let’s focus on why it’s important. Here are a few reasons we significantly invested in your facility, production setup, and team training for compliance:
- Drug efficacy: If the APIs don’t achieve the desired efficacy, the drug won’t perform as intended.
- Patient safety: Impurities, contamination, or poor API efficacy directly affect the patient’s health.
- Regulatory approvals: Pharma regulatory authorities have strict requirements for APIs and drugs entering their markets.
- Business reputation: Regulatory compliance builds market reputation and saves the drug development company from potential recalls and penalties.
- Market entry: API compliance ensures that the pharma products get marketing approval in diverse new markets.
How Does Chemox Pharma Ensure API Compliance?
Chemox Pharma offers 21 WHO-GMP APIs, and here’s how we ensure that they meet global standards.
Certification
One of the most reliable indicators of the API manufacturer’s compliance is their certificates. GMP certification indicates that the manufacturer meets the safety standards.
Here are our regulatory certifications to ensure our compliance:
WHO GMP
WHO-GMP (Good Manufacturing Practices) certification indicates that the manufacturer is adhering to international standards. The WHO-GMP certification can help you enter the WHO member countries easily.
It indicates that the manufacturer has:
- Validated manufacturing processes
- Controlled production environments
- Strict hygiene protocols
- Equipment calibration and maintenance
- Documented SOP implementation
Chemox Pharma holds WHO-GMP certification, demonstrating our adherence to international production standards.
ISO
ISO stands for International Organization for Standardization. It’s a global, independent, and non-government body known for developing and publishing production standards. These standards minimize errors and failures. Adherence to these standards in the pharma industry helps manufacturers develop compliant and safe drugs.
Chemox Pharma has two important ISO certifications for pharma companies:
- ISO 9001:2015 (Quality Management System)
- ISO 14001:2015 (Environmental Management System)
GLP adherence
Good Laboratory Practice certification ensures that your non-clinical laboratory studies are accurate. This certificate is essential to demonstrate your reliability, reproducibility, and integrity. Chemox Pharma strictly monitors all our procedures and records them accurately.
DUNS identification
DUNS certification includes a numerical identifier allocated by Dun & Bradstreet (D&B). The DUNS number is essential to prove your legitimacy, credibility, and business identity in international markets. Chemox Pharma’s facility has been verified by the agency, demonstrating its compliance with the law.
FEI identification
FEI, or FDA Establishment Identifier, is a numeric identifier assigned by the FDA. If you want to operate in a market regulated by the FDA, you must have an FEI ID. This ID ensures that you are complying with the FDA’s standards at the manufacturing site. Chemox Pharma has FEI identification and is always ready for inspections.
Pharmexcil
Pharmexcil certification strengthens Chemox Pharma’s export capabilities. The certification establishes that Chemox Pharma meets both international pharmaceutical trade standards and regulatory requirements, which increases buyer confidence.
Quality control compliance
One of the most critical trust-building factors in the pharma industry is quality control. The quality assurance in pharma companies ensures that APIs have a balanced profile, lower impurities, and consistent quality throughout the production cycle.
Chemox Pharma has set up a QA system that analyzes and records the quality data at various production stages. We record data for each production cycle to ensure batch consistency and regulatory adherence.
Stability testing & documentation
The safety of the API depends on its stability testing. Through controlled tests, the API manufacturing company identifies the best environment for the API to maintain its potency. Chemox Pharma uses advanced technology to assess API stability and safety and to design the best packaging for delivery without damage.
Rigorous team training
The technical team is the heart of any API manufacturer. Therefore, all our team members undergo structured training before joining. The training course is designed to help them understand the GMP standards and protocols.
Chemox Pharma can help you customize the pharmacopoeial standards for APIs to meet your needs. We can customize the API standards to meet INH, BP, USP, IP, and EP requirements. Contact us to know more.
Conclusion
API compliance is essential for demonstrating a pharma company’s trustworthiness, reliability, and global competitiveness. The GMP certification, quality control, and stability testing help Chemox Pharma prove its commitment to quality. We adhere to WHO-GMP standards for our manufacturing facility and processes. We can customize the pharmacopoeial standards for APIs to meet your needs. Contact us to know more.
FAQs
What is quality assurance in the pharma industry?
Quality assurance in pharma indicates whether pharma products are produced in accordance with predefined quality standards. The quality standards include values for impurities, chemical profile, and more. QA ensures that APIs meet regulatory requirements for APIs and remain safe, effective, and consistent. The pharma company must get approval from a reputable quality assurance authority.
What are the regulatory requirements for API pharma products?
The following are a few factors that API companies need to test for regulatory compliance:
- Controlled production processes
- Impurity profiling
- Stability testing
They also need to maintain clear documentation, batch manufacturing records, and analysis certificates. Compliance with WHO-GMP APIs standards and other international certifications strengthens global acceptance and reduces regulatory risk.
Who is the best manufacturer of WHO-GMP APIs in India?
Chemox Pharma is one of the best and most reliable API manufacturers in India with WHO-GMP approval. Our facility and production processes are designed to align with the WHO-GMP standards. We also have ISO, GLP, DUNS, FEI, and Pharmexcil certifications. Therefore, all our products are safe and stable for further development. Contact us to get answers to your query.
How does pharma compliance work in India?
The pharma companies in India often follow the guidelines of national and international regulatory authorities. Manufacturers must follow strict facility design requirements, validated production processes, quality control testing, and complete documentation systems. Certifications such as WHO-GMP and ISO reinforce compliance credibility. Companies exporting APIs must also meet international regulatory requirements for APIs and maintain audit-ready systems.
