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BatchMaster Software Pvt. Ltd

Pharmaceutical API ERP Software

4.4 rating on

BatchMaster ERP is built around how API plants actually run. Formulation, batch synthesis, GMP/CDSCO compliance, by-product control, lot traceability and finance sit in one system, so your team stops re-entering the same batch data three different ways.

  • 3000+ Global Implementations
  • Trusted by Pharma & API Manufacturers
  • 40+ Years in Process Manufacturing
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What Changes Once BatchMaster Runs Your API Operations

  • Formulation, batch sizes and multi-UOM raw materials are tracked together across starting material, intermediates, isolation and purification
  • GMP, CDSCO and FDA 21 CFR Part 11 records get generated as you work, not reconstructed after the fact
  • Lot traceability runs both directions, so a recall search that used to take days takes minutes
  • Inventory shows quarantine status and shelf life in real time, with by-products and impurities accounted for instead of left off the books
  • Costing rolls up by formula, batch and customer, whether you're manufacturing in-house, on contract, or under a loan license

Works With Your Financial Systems

Tally
SAP Business One
Sage
QuickBooks
Xero

What is API Manufacturing ERP Software?

API Manufacturing ERP software is a business management system designed for Active Pharmaceutical Ingredient (API) manufacturers. It connects formulation, production, quality control, inventory, procurement, batch records, lot traceability, compliance, and costing in one platform, helping API manufacturers improve process control, product quality, traceability, and operational efficiency.

Unlike generic ERP systems, active pharmaceutical ingredient ERP includes capabilities such as formula security, FDA 21 CFR Part 11 compliance, QC and stability testing, electronic batch records, CAPA and non-conformance management, shelf-life tracking, and bi-directional lot traceability that are critical for API manufacturing operations.

Trusted by Leading Pharmaceutical & API Manufacturers

What's Actually Slowing Your API Business Down

GMP & CDSCO Compliance Burden

Regulators on both the producing and consuming side keep raising the bar. If your GMP documentation, CDSCO filings and FDA 21 CFR Part 11 records still live in spreadsheets and binders, someone on your team is losing hours to paperwork that a system should be doing for them.

Formulation & Batch Consistency

Scale a synthesis process across starting materials, intermediates and purification without a single source of truth for the formula, and purity, yield and quality start to drift between batches — even when the recipe hasn't changed on paper.

By-Product & Impurity Management

Every synthesis run throws off reagents, catalysts, ligands and impurities that need to be classified, tracked and disposed of correctly. Lose track of any of it and you're looking at compliance gaps and material that just goes to waste.

Margin Pressure from Patent Expiry

As branded products go off-patent, more players chase the same volume and prices get pushed down. The manufacturers protecting margin here are the ones who actually know their formula and batch costs, down to the reagent.

Lot Traceability & Recall Readiness

A quality complaint or adverse event doesn't wait for a convenient time. Regulators expect you to name the affected batches within minutes of asking, in both directions — and that only works if traceability was built in from the start.

Disconnected Financials & Production Data

Production runs in one system, accounting in another — that's still the norm at a lot of API plants. The result is costing errors, inventory that never quite matches, and no one able to say with confidence what a batch actually cost to make.

Why BatchMaster ERP

Purpose-Built API ERP for Formulation, Compliance & Traceability

Most generic ERP systems ask API manufacturers to bend their process to fit the software. BatchMaster’s ERP Software for API Manufacturing was built the other way around — for the specific realities of active pharmaceutical ingredient production, on one platform, whether you manufacture in-house, on contract, or under a loan license.

GMP/CDSCO-Aligned Compliance Engine

GMP documentation, CDSCO filings, FDA 21 CFR Part 11 records and adverse-event reporting live in one place, ready for an audit whenever one comes.

Industry-Specific, Not a Generic ERP

Starting material, intermediates, isolation, purification, packaging — the software follows the same stages your plant does, because it was designed around them.

40+ Years. 3,000+ Implementations.

We've been doing this a while, and it shows up in the implementation team as much as the product itself.

Cloud or On-Premise — Your Choice

Some plants want access from anywhere; others need to keep every byte on-site. BatchMaster runs either way.

Request a Demo

Driving Success Across All Pharmaceutical Segments

Pharmaceutical manufacturing requires specialized technology. Select a pharmaceutical ERP solution built for the industry, with the capabilities needed to manage formulations, regulatory compliance, quality processes, and scalable growth.

Active Pharmaceutical Ingredient ERP — Compliance Made Easy

Ensure Compliance with Global Pharmaceutical Regulations

Pharmaceutical safety rules keep changing, and keeping up with them by hand isn’t sustainable at scale. BatchMaster’s API software takes over the compliance grunt work — the filings, the sign-offs, the traceability — so your team can focus on running the plant.

  • GMP
  • CDSCO
  • ICH Q7
  • DMF
  • GST / E-Invoicing
  • WHO-GMP
  • FDA 21 CFR Part 11
  • Adverse Event Reporting

01

GMP & CDSCO Compliance Documentation

GMP records, CDSCO filing data and product-level documentation get generated as work happens, not assembled after the fact for an audit.

02

FDA 21 CFR Part 11 Electronic Records

Electronic batch records come with audit trail, e-signatures and approval workflow already built in — no separate system to reconcile.

03

Lot Traceability for Recalls

Trace a lot forward or backward, from the starting-material supplier all the way to the customer, in the time it takes to run a query.

04

GST Billing & E-Invoicing

GST-compliant invoices, e-invoices and HSN/SAC-mapped billing flow straight into your accounting platform.

05

CAPA & Non-Conformance Management

Log a corrective or preventive action against any batch, deviation or complaint, and track it through to close-out.

06

Adverse Event & Complaint Reporting

Complaints, adverse events and returns get logged, investigated and reported within the timelines regulators expect.

See BatchMaster ERP in Action

Core Capabilities

What's Inside BatchMaster

From sourcing raw material to dispatching the finished API, here’s where each piece of the system fits into the process.

Formula Management

Every API formula lives in one secured, version-controlled place with its own approval workflow — and the same formula can carry across your own manufacturing, contract work, or a loan-licensing arrangement.

  • Set exact raw-material ratios, reagent quantities, and process parameters per formula
  • Multi-level approval and a full audit trail on every formula change
  • Scale a batch up or down without redoing the math by hand
  • Swap in a substitute material quickly if a reagent runs short
  • One formula can serve multiple products and BOMs
Learn More
Formula — [Drug Name] API v2.1
Starting Material
62.5 kg
Catalyst
0.8 kg
Reaction Temp Range
26–28 °C
Expected Yield
96.2%
Recipe compliance status

92% — GMP compliant

Batch Production & Shop-Floor Control

From the starting-material charge through intermediates, isolation, purification, and packaging, operators log data in real time and SOPs get enforced as they go, not checked after the fact.

  • Electronic batch ticket, weigh sheet, and Manufacturing Batch Record (MBR) in one place
  • SOPs run as inspection checklists rather than paper instructions
  • Batch monitoring tied to a defined inspection plan
  • Scheduling that accounts for reactor capacity and where demand is heading
  • Works across own manufacturing, contract manufacturing, and loan-licensing
Learn More
Production Order — Batch #BT-2406-081
Product
[API Name]
Batch Qty
200 kg
Stage
Purification
Reactor Load
R-3
58% — Stage 3 of 6

By-Product & Inventory Management

Synthesis doesn’t just produce the finished API — it produces everything around it too. BatchMaster keeps starting materials, intermediates, reagents, catalysts, and by-products visible in real time.

  • Classify materials as starting material, by-product, intermediate, reagent, ligand, catalyst, or impurity
  • Safety Data Sheets attached for handling and transport, so employee safety isn’t guesswork
  • Shelf-life and expiry tracked with FIFO or FEFO rotation
  • Handheld RF devices for warehouse moves across multiple facilities
Learn More
Inventory — Quarantine & Expiry Dashboard
Starting Material A
42 days left
Catalyst B
8 days left ⚠
Reagent C
30 days left
By-product D
Pending disposal 🔴
78% in healthy range

Bi-Directional Lot Traceability

When a quality issue or adverse event comes up, you don’t have time to dig through paper trails. Every raw material is tracked through every stage to every shipment it ends up in.

  • Forward: raw material supplier → synthesis → purification → finished API → customer
  • Backward: start from a complaint, find the affected lots, isolate the stock
  • Electronic Batch Records (EBR & MBR) kept for every run, not just the flagged ones
  • Lot-level status — quarantine, release, or reject — set according to cGMP norms
Learn More
Lot Trace — LOT-2406-044
Raw Material
Supplier X
GRN Date
04 Jun 2026
Used In Batch
BT-081, -082
Recall Affected
None
100% — fully traceable

Costing & Margin Analysis

Formula cost and packaging cost are tracked separately and in detail, so you actually know what each API costs to make — and can price it, and protect the margin, accordingly.

  • Formula and packaging material costed separately, down to the detail
  • Run ‘what-if’ scenarios across multiple costing methods before committing
  • Compare actual cost against standard cost, batch by batch
  • Posts straight through to Tally, SAP B1, or QuickBooks at the GL level
Learn More
Margin Analysis — May 2026
API Product A
38.4% margin
API Product B
21.1% margin ↓
Std vs Actual Cost
+₹1.2/kg
100% — fully traceable

Quality Control & Inspection

Quality gets checked at incoming inspection, at in-process checkpoints, and again at final release — nothing goes out the door below cGMP standard.

  • Sampling plans and stability testing built into QC
  • QC tests defined per cGMP norms, with quarantine, release, or reject outcomes
  • CAPA and non-conformance management tied directly to the affected batch
  • One module handles complaints, returns, and recalls together
Learn More
QC Inspection — Batch BT-2406-082
Purity
99.6% ✓ Pass
Residual Solvent
Within Limit ✓
Moisture Content
0.4% ⚠ Review
COA Status
Auto-generated
97% first-pass quality rate

Formula Management

Every API formula lives in one secured, version-controlled place with its own approval workflow — and the same formula can carry across your own manufacturing, contract work, or a loan-licensing arrangement.

  • Set exact raw-material ratios, reagent quantities, and process parameters per formula
  • Multi-level approval and a full audit trail on every formula change
  • Scale a batch up or down without redoing the math by hand
  • Swap in a substitute material quickly if a reagent runs short
  • One formula can serve multiple products and BOMs
Learn More
Formula — [Drug Name] API v2.1
Starting Material
62.5 kg
Catalyst
0.8 kg
Reaction Temp Range
26–28 °C
Expected Yield
96.2%
Recipe compliance status

92% — GMP compliant

Batch Production & Shop-Floor Control

From the starting-material charge through intermediates, isolation, purification, and packaging, operators log data in real time and SOPs get enforced as they go, not checked after the fact.

  • Electronic batch ticket, weigh sheet, and Manufacturing Batch Record (MBR) in one place
  • SOPs run as inspection checklists rather than paper instructions
  • Batch monitoring tied to a defined inspection plan
  • Scheduling that accounts for reactor capacity and where demand is heading
  • Works across own manufacturing, contract manufacturing, and loan-licensing
Learn More
Production Order — Batch #BT-2406-081
Product
[API Name]
Batch Qty
200 kg
Stage
Purification
Reactor Load
R-3
58% — Stage 3 of 6

By-Product & Inventory Management

Synthesis doesn’t just produce the finished API — it produces everything around it too. BatchMaster keeps starting materials, intermediates, reagents, catalysts, and by-products visible in real time.

  • Classify materials as starting material, by-product, intermediate, reagent, ligand, catalyst, or impurity
  • Safety Data Sheets attached for handling and transport, so employee safety isn’t guesswork
  • Shelf-life and expiry tracked with FIFO or FEFO rotation
  • Handheld RF devices for warehouse moves across multiple facilities
Learn More
Inventory — Quarantine & Expiry Dashboard
Starting Material A
42 days left
Catalyst B
8 days left ⚠
Reagent C
30 days left
By-product D
Pending disposal 🔴
78% in healthy range

Bi-Directional Lot Traceability

When a quality issue or adverse event comes up, you don’t have time to dig through paper trails. Every raw material is tracked through every stage to every shipment it ends up in.

  • Forward: raw material supplier → synthesis → purification → finished API → customer
  • Backward: start from a complaint, find the affected lots, isolate the stock
  • Electronic Batch Records (EBR & MBR) kept for every run, not just the flagged ones
  • Lot-level status — quarantine, release, or reject — set according to cGMP norms
Learn More
Lot Trace — LOT-2406-044
Raw Material
Supplier X
GRN Date
04 Jun 2026
Used In Batch
BT-081, -082
Recall Affected
None
100% — fully traceable

Costing & Margin Analysis

Formula cost and packaging cost are tracked separately and in detail, so you actually know what each API costs to make — and can price it, and protect the margin, accordingly.

  • Formula and packaging material costed separately, down to the detail
  • Run ‘what-if’ scenarios across multiple costing methods before committing
  • Compare actual cost against standard cost, batch by batch
  • Posts straight through to Tally, SAP B1, or QuickBooks at the GL level
Learn More
Margin Analysis — May 2026
API Product A
38.4% margin
API Product B
21.1% margin ↓
Std vs Actual Cost
+₹1.2/kg
100% — fully traceable

Quality Control & Inspection

Quality gets checked at incoming inspection, at in-process checkpoints, and again at final release — nothing goes out the door below cGMP standard.

  • Sampling plans and stability testing built into QC
  • QC tests defined per cGMP norms, with quarantine, release, or reject outcomes
  • CAPA and non-conformance management tied directly to the affected batch
  • One module handles complaints, returns, and recalls together
Learn More
QC Inspection — Batch BT-2406-082
Purity
99.6% ✓ Pass
Residual Solvent
Within Limit ✓
Moisture Content
0.4% ⚠ Review
COA Status
Auto-generated
97% first-pass quality rate

BatchMaster ERP for API Manufacturers: GMP Compliance, Quality & Traceability

Discover how our API manufacturing ERP software streamlines formulation management, production, quality assurance, costing, and GMP compliance.

Download Brochure
API-inr

Ready to Get Started?

See It Running on a Real Batch

Pharmaceutical and API manufacturers have moved off spreadsheets and off generic ERP for a system that actually matches how they work. Ask for a demo and see it against your own process.

Schedule a Free Demo

Security & Infrastructure

Enterprise-Grade Security. Audit-Ready Infrastructure.

Built and hosted to the standards that regulated pharmaceutical manufacturers require.

ISO Certified

ISO 9001 quality management

Data Encryption

End-to-end, in transit & at rest

Secure Cloud Hosting

99.9% uptime SLA

SLA-Backed Support

Defined response times

Privacy & Compliance

GDPR & data protection

24×7 Support

Round-the-clock global coverage

Frequently Asked Questions

An API manufacturing ERP should include formulation and formula security, batch production management, MRP, inventory and warehouse management, quality control, stability testing, electronic batch records, CAPA and non-conformance management, lot traceability, costing, supplier management, and regulatory compliance capabilities.

Yes. A pharmaceutical ERP designed for regulated manufacturing can support 21 CFR Part 11-related processes through electronic records, audit trails, electronic signatures, controlled workflows, and approvals. BatchMaster’s API solution specifically includes electronic records and approval workflows for this purpose.

API ERP software can provide bi-directional lot traceability, allowing manufacturers to trace materials from suppliers through intermediates and finished APIs and trace finished batches backward to the materials and production processes used. This makes investigations, quality management, and recalls faster and more controlled.

Yes. An API-specific ERP should support the different stages of API manufacturing, including starting materials, intermediates, isolation, purification, packaging, by-products, reagents, catalysts, and impurities. This provides better inventory control, material utilization, and production visibility.

Yes. API manufacturing ERP can integrate quality control processes such as sampling plans, stability testing, specification-based QC tests, quarantine/release/reject decisions, non-conformance management, and CAPA with the relevant batches.